A Phase 3 interventional study of Vancomycin 1.1% and Placebo in Bacterial Conjunctivitis, sponsored by Kurobe LLC. Completed at 16 sites in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2024-10-23.
Sponsored by Kurobe LLC · Phase 3, Interventional, and Treatment
This is a Phase 3 study to evaluate the safety and efficacy of a vancomycin hydrochloride ophthalmic ointment dosed 4 times daily for 7 days compared to placebo (vehicle) in patients with moderate to severed Gram-positive bacterial conjunctivitis.
Bacterial conjunctivitis is common ocular disease caused by various types of bacteria including methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-resistant Staphylococcus epidermidis (MRSE). External ocular infections such as those caused by MRSA or MRSE frequently are not serious but in rare cases may be severe enough to threaten vision. When ocular infections due to resistant organisms such as MRSA/MRSE do not respond to empiric treatment with approved antibiotics, there are few treatment options. Vancomycin is one of the few treatment options that has been shown to be effective against all clinical isolates of MRSA/MRSE.
This study is a Phase 3 study to evaluate the safety and efficacy of a vancomycin hydrochloride ophthalmic ointment in patients with moderate to severed Gram-positive bacterial conjunctivitis including those with MRSA and MRSE. Subjects, who are adenovirus negative, will be dosed with vancomycin hydrochloride ophthalmic ointment or placebo (vehicle) 4 times daily for 7 days and evaluated for clinical and bacterial resolution of their infection along with an assessment of the safety of the investigational product.
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's enrollment of 303 is above the median of 261 across 36 interventional studies indexed under Conjunctivitis, Bacterial.
Browse Conjunctivitis, Bacterial studies →This is the only study on the registry with Kurobe LLC as lead sponsor.
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.
Exclusion Criteria:
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
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.
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.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
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.
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.
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.
Vancomycin hydrochloride ophthalmic ointment 1.1% dosed approximately 1 cm of ointment QID for 7 days
Drug: Vancomycin 1.1%
Vehicle (placebo) ophthalmic ointment dosed approximately 1 cm of ointment QID for 7 days
Drug: Placebo
Vancomycin hydrochloride ophthalmic ointment 1.1%
Placebo
Number of Subjects With Clinical Resolution of Bacterial Conjunctivitis
Between-group difference in clinical resolution of bacterial conjunctivitis (defined as absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection) at Day 8
Time frame: 8 days
Number of Subjects That Display Microbial Eradication
Between-group difference in microbial eradication (absence of all Gram-positive bacterial species present at or above the pathological threshold at baseline) at Day 8
Time frame: 8 days
| Milestone | Vancomycin 1.1% | Placebo |
|---|---|---|
| Started | 152 | 151 |
| Completed | 149 | 147 |
| Not completed | 3 | 4 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Other | 1 | 1 |
Between-group difference in clinical resolution of bacterial conjunctivitis (defined as absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection) at Day 8
| Participants | Vancomycin 1.1% | Placebo |
|---|---|---|
| Number of Subjects With Clinical Resolution of Bacterial Conjunctivitis | 71 | 59 |
Between-group difference in microbial eradication (absence of all Gram-positive bacterial species present at or above the pathological threshold at baseline) at Day 8
| Participants | Vancomycin 1.1% | Placebo |
|---|---|---|
| Number of Subjects That Display Microbial Eradication | 56 | 43 |
Collected over 8 days of treatment. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vancomycin 1.1% | 0/152 (0%) | 0/152 (0%) | 5/152 (3.3%) |
| Placebo | 0/151 (0%) | 1/151 (0.7%) | 16/151 (10.6%) |
| Event | Vancomycin 1.1% | Placebo |
|---|---|---|
| DehydrationMetabolism and nutrition disorders | 0/152 | 1/151 |
| Event | Vancomycin 1.1% | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 2/152 | 4/151 |
| VomitingGastrointestinal disorders | 0/152 | 3/151 |
| PyrexiaGeneral disorders | 1/152 | 3/151 |
| Dry eyeEye disorders | 0/152 | 2/151 |
| Punctate keratitisEye disorders | 2/152 | 2/151 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/152 | 2/151 |
| Age, Continuous(years) | Vancomycin 1.1% | Placebo | Total |
|---|---|---|---|
| Mean | 31.5 ± 23.69 | 31.9 ± 26.73 | 31.7 ± 25.21 |
| Sex: Female, Male(Participants) | Vancomycin 1.1% | Placebo | Total |
|---|---|---|---|
| Female | 95 | 83 | 178 |
| Male | 57 | 68 | 125 |
| Ethnicity (NIH/OMB)(Participants) | Vancomycin 1.1% | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 37 | 39 | 76 |
| Not Hispanic or Latino | 115 | 112 | 227 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Vancomycin 1.1% | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 8 | 5 | 13 |
| Native Hawaiian or Other Pacific Islander | 1 | 3 | 4 |
| Black or African American | 8 | 14 | 22 |
| White | 134 | 124 | 258 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 4 | 5 |
| Region of Enrollment(participants) | Vancomycin 1.1% | Placebo | Total |
|---|---|---|---|
| United States | 152 | 151 | 303 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2015 to primary completion in May 2018, 36 months.
Results were first posted in Oct 2024, 6 years 4 months after primary completion.
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Studies of the drug tested here: Vancomycin