A Phase 3 interventional study of SHP640 and PVP-I 0.6% in Bacterial Conjunctivitis, sponsored by Shire. Completed at 163 sites in 13 countries. Per ClinicalTrials.gov, last updated 2021-06-09.
Sponsored by Shire (part of Takeda) · Phase 3, Interventional, and Treatment
The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial conjunctivitis.
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's enrollment of 753 is above the median of 261 across 36 interventional studies indexed under Conjunctivitis, Bacterial.
Browse Conjunctivitis, Bacterial studies →Shire is the lead sponsor of 351 studies on the registry; 2 are open to participants now.
Of its 48 completed or terminated interventional studies of FDA-regulated products, 48 (100%) have results posted.
First submitted before Shire became part of Takeda.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have a clinical diagnosis of suspected bacterial conjunctivitis in at least 1 eye confirmed by the presence of the following minimal clinical signs and symptoms in that same eye:
Exclusion Criteria:
Within 30 days prior to the first dose of investigational product:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will instill 1 drop of SHP640 (povidone-iodine \[PVP-I\] 0.6 percent \[%\] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
Drug: SHP640
Participants will instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID for 7 days
Drug: PVP-I 0.6%
Participants will instill 1 drop of placebo ophthalmic solution in each eye 4 times QID for 7 days.
Drug: Placebo
Instill 1 drop of SHP640 (povidone-iodine \[PVPI\] 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.
Instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.
Instill 1 drop of placebo ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.
Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5
Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
Time frame: Day 5
Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5
Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on colony-forming unit (CFU)/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
Time frame: Baseline, Day 5
Number of Participants With Clinical Resolution
Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of atleast 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
Time frame: Day 3, 8 and 12
Number of Participants With Bacterial Eradication
Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on CFU/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant.
Time frame: Day 3, 8 and 12
Bulbar Conjunctival Injection Score
Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.
Time frame: Day 3, 5, 8 and 12
Change From Baseline in the Bulbar Conjunctival Injection Score
Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.
Time frame: Baseline, Day 3, 5, 8 and 12
Ocular Conjunctival Discharge Score
Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
Time frame: Day 3, 5, 8 and 12
Change From Baseline in the Ocular Conjunctival Discharge Score
Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
Time frame: Baseline, Day 3, 5, 8 and 12
Global Clinical Score
Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
Time frame: Day 3, 5, 8 and 12
Change From Baseline in the Global Clinical Score
Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
Time frame: Baseline, Day 3, 5, 8 and 12
Number of Participants With Modified Clinical Resolution
Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
Time frame: Day 3, 5, 8 and 12
Number of Participants With Expanded Clinical Resolution
Expanded clinical resolution was defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
Time frame: Day 3, 5, 8 and 12
Time to Clinical Resolution
Clinical resolution was defined as absence (score of 0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Time to clinical resolution defined as the date on which a participant first reached clinical resolution minus the date of first dose of investigational product, plus 1.
Time frame: Baseline to Day 12
Number of Participants Who Used Rescue Medication
Rescue treatment with a licensed antibiotic according to the local standard of care was provided to participants if, in the judgment of the investigator, there was no clinical improvement or worsening of their condition to an extent that it would be in the best interest of the participant treated with an alternate therapy for safety reasons.
Time frame: Baseline to Day 12
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Any AE that occured after the first dose of investigational product instillation was considered a TEAE.
Time frame: From start of study drug administration up to 14 days
Study was conducted at 121 centers in 14 countries between 29 Mar 2017 (first participant first visit) and 01 Oct 2018 (last participant last visit).
| Milestone | SHP640 | PVP-I 0.6% | Placebo |
|---|---|---|---|
| Started | 324 | 108 | 321 |
| Completed | 297 | 94 | 293 |
| Not completed | 27 | 14 | 28 |
| Withdrew: Adverse event | 6 | 5 | 10 |
| Withdrew: Protocol violation | 4 | 0 | 1 |
| Withdrew: Withdrawal by subject | 5 | 3 | 5 |
| Withdrew: Lost to follow-up | 6 | 1 | 4 |
| Withdrew: Lack of efficacy | 2 | 4 | 2 |
| Withdrew: Physician decision | 1 | 0 | 1 |
| Withdrew: Withdrawal by parent/guardian | 1 | 0 | 2 |
| Withdrew: Screen failure | 1 | 0 | 0 |
| Withdrew: Pregnancy | 0 | 1 | 0 |
| Withdrew: Terminated by sponsor | 0 | 0 | 1 |
| Withdrew: Missed study visit | 0 | 0 | 2 |
| Withdrew: Hsv1 positive | 1 | 0 | 0 |
Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
| Participants | SHP640 | PVP-I 0.6% | Placebo |
|---|---|---|---|
| Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5 | 111 | 0 | 95 |
Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on colony-forming unit (CFU)/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
| Participants | SHP640 | PVP-I 0.6% | Placebo |
|---|---|---|---|
| Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5 | 94 | 0 | 102 |
Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of atleast 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
| Participants | SHP640 | PVP-I 0.6% | Placebo |
|---|---|---|---|
| Day 3 | 39 | 6 | 39 |
| Day 8 | 148 | 39 | 133 |
| Day 12 | 150 | 47 | 154 |
Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on CFU/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant.
| Participants | SHP640 | PVP-I 0.6% | Placebo |
|---|---|---|---|
| Day 3 | 76 | 33 | 79 |
| Day 8 | 85 | 25 | 87 |
| Day 12 | 83 | 21 | 82 |
Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.
| Score on a scale | SHP640 | PVP-I 0.6% | Placebo |
|---|---|---|---|
| Day 3 | 1.0 ± 0.84 | 1.3 ± 0.90 | 1.1 ± 0.86 |
| Day 5 | 0.5 ± 0.77 | 0.7 ± 0.88 | 0.7 ± 0.80 |
| Day 8 | 0.3 ± 0.64 | 0.4 ± 0.61 | 0.4 ± 0.61 |
| Day 12 | 0.2 ± 0.56 | 0.2 ± 0.47 | 0.2 ± 0.48 |
Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.
| Score on a scale | SHP640 | PVP-I 0.6% | Placebo |
|---|---|---|---|
| Day 3 | -1.0 ± 0.77 | -0.8 ± 0.76 | -0.9 ± 0.76 |
| Day 5 | -1.5 ± 0.87 | -1.3 ± 0.99 | -1.3 ± 0.85 |
| Day 8 | -1.8 ± 0.91 | -1.6 ± 0.86 | -1.6 ± 0.81 |
| Day 12 | -1.8 ± 0.89 | -1.8 ± 0.74 | -1.8 ± 0.82 |
Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
| Score on a scale | SHP640 | PVP-I 0.6% | Placebo |
|---|---|---|---|
| Day 3 | 0.7 ± 0.73 | 0.8 ± 0.74 | 0.7 ± 0.76 |
| Day 5 | 0.3 ± 0.57 | 0.2 ± 0.44 | 0.4 ± 0.60 |
| Day 8 | 0.1 ± 0.43 | 0.1 ± 0.31 | 0.2 ± 0.47 |
| Day 12 | 0.1 ± 0.49 | 0.0 ± 0.22 | 0.1 ± 0.28 |
Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
| Score on a scale | SHP640 | PVP-I 0.6% | Placebo |
|---|---|---|---|
| Day 3 | -0.9 ± 0.77 | -0.8 ± 0.67 | -0.9 ± 0.85 |
| Day 5 | -1.4 ± 0.74 | -1.4 ± 0.75 | -1.3 ± 0.75 |
| Day 8 | -1.5 ± 0.71 | -1.5 ± 0.73 | -1.4 ± 0.74 |
| Day 12 | -1.5 ± 0.76 | -1.6 ± 0.71 | -1.6 ± 0.73 |
Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
| Score on a scale | SHP640 | PVP-I 0.6% | Placebo |
|---|---|---|---|
| Day 3 | 1.7 ± 1.37 | 2.1 ± 1.39 | 1.9 ± 1.42 |
| Day 5 | 0.8 ± 1.18 | 0.9 ± 1.19 | 1.0 ± 1.18 |
| Day 8 | 0.4 ± 0.93 | 0.5 ± 0.77 | 0.6 ± 0.93 |
| Day 12 | 0.4 ± 0.90 | 0.3 ± 0.55 | 0.3 ± 0.67 |
Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
| Score on a scale | SHP640 | PVP-I 0.6% | Placebo |
|---|---|---|---|
| Day 3 | -1.9 ± 1.28 | -1.6 ± 1.22 | -1.8 ± 1.30 |
| Day 5 | -2.9 ± 1.27 | -2.8 ± 1.47 | -2.6 ± 1.31 |
| Day 8 | -3.2 ± 1.36 | -3.2 ± 1.25 | -3.1 ± 1.25 |
| Day 12 | -3.3 ± 1.38 | -3.4 ± 1.06 | -3.3 ± 1.23 |
Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
| Participants | SHP640 | PVP-I 0.6% | Placebo |
|---|---|---|---|
| Day 3 | 100 | 28 | 93 |
| Day 5 | 166 | 48 | 143 |
| Day 8 | 189 | 59 | 175 |
| Day 12 | 182 | 59 | 173 |
Expanded clinical resolution was defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
| Participants | SHP640 | PVP-I 0.6% | Placebo |
|---|---|---|---|
| Day 3 | 155 | 46 | 154 |
| Day 5 | 185 | 54 | 171 |
| Day 8 | 193 | 63 | 192 |
| Day 12 | 185 | 61 | 181 |
Clinical resolution was defined as absence (score of 0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Time to clinical resolution defined as the date on which a participant first reached clinical resolution minus the date of first dose of investigational product, plus 1.
| Days | SHP640 | PVP-I 0.6% | Placebo |
|---|---|---|---|
| Time to Clinical Resolution | 5 (5.0 to 8.0) | 6 (5.0 to 8.0) | 8 (5.0 to 8.0) |
Rescue treatment with a licensed antibiotic according to the local standard of care was provided to participants if, in the judgment of the investigator, there was no clinical improvement or worsening of their condition to an extent that it would be in the best interest of the participant treated with an alternate therapy for safety reasons.
| Participants | SHP640 | PVP-I 0.6% | Placebo |
|---|---|---|---|
| Number of Participants Who Used Rescue Medication | 2 | 3 | 4 |
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Any AE that occured after the first dose of investigational product instillation was considered a TEAE.
| Participants | SHP640 | PVP-I 0.6% | Placebo |
|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 106 | 43 | 61 |
Collected over From start of study drug administration up to 14 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SHP640 | 0/323 (0%) | 0/323 (0%) | 67/323 (20.7%) |
| PVP-I 0.6% | 0/108 (0%) | 0/108 (0%) | 26/108 (24.1%) |
| Placebo | 0/321 (0%) | 0/321 (0%) | 7/321 (2.2%) |
| Event | SHP640 | PVP-I 0.6% | Placebo |
|---|---|---|---|
| Instillation site painGeneral disorders | 67/323 | 26/108 | 7/321 |
ITT population included all randomized participants.
| Age, Continuous(Years) | SHP640 | PVP-I 0.6% | Placebo | Total |
|---|---|---|---|---|
| Mean | 44.2 ± 22.87 | 43.1 ± 23.03 | 44.7 ± 23.00 | 44.3 ± 22.92 |
| Sex: Female, Male(Participants) | SHP640 | PVP-I 0.6% | Placebo | Total |
|---|---|---|---|---|
| Female | 191 | 71 | 199 | 461 |
| Male | 133 | 37 | 122 | 292 |
| Race/Ethnicity, Customized(Participants) | SHP640 | PVP-I 0.6% | Placebo | Total |
|---|---|---|---|---|
| Ethnicity — Hispanic or Latino | 62 | 30 | 87 | 179 |
| Ethnicity — Not Hispanic or Latino | 254 | 76 | 230 | 560 |
| Ethnicity — Not reported | 4 | 2 | 2 | 8 |
| Ethnicity — Other | 4 | 0 | 2 | 6 |
| Race/Ethnicity, Customized(Participants) | SHP640 | PVP-I 0.6% | Placebo | Total |
|---|---|---|---|---|
| Race — American Indian or Alaska Native | 0 | 1 | 3 | 4 |
| Race — Asian | 12 | 0 | 8 | 20 |
| Race — Black or African American | 54 | 18 | 54 | 126 |
| Race — White | 250 | 88 | 250 | 588 |
| Race — Native Hawaiian or Other Pacific Islander | 0 | 0 | 2 | 2 |
| Race — Other | 6 | 1 | 4 | 11 |
| Race — Multiple | 2 | 0 | 0 | 2 |
Showing the first 100 of 163 sites across 13 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Data sharing details ↗ · vivli.org
Ran from Mar 2017 to primary completion in Oct 2018, 18 months.
Results were first posted in Oct 2019, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: SHP640