A Phase 3 interventional study of Besivance and Vehicle in Bacterial Conjunctivitis, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2013-05-01.
Sponsored by Bausch & Lomb Incorporated (part of Bausch Health Companies Inc.) · Phase 3, Interventional, and Treatment
The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's enrollment of 518 is above the median of 261 across 36 interventional studies indexed under Conjunctivitis, Bacterial.
Browse Conjunctivitis, Bacterial studies →Bausch & Lomb Incorporated is the lead sponsor of 223 studies on the registry; 5 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 41 (80%) have results posted.
First submitted before Bausch & Lomb Incorporated became part of Bausch Health Companies Inc..
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.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
besifloxacin ophthalmic suspension 0.6%
Drug: Besivance
Vehicle of Besivance
Drug: Vehicle
Ocular administration to affected eye for 7 days
Vehicle of Besivance administered to affected eye for 7 days
Ocular Treatment Emergent Adverse Events
Ocular Treatment-Emergent Adverse Events on the Study Eye
Time frame: At each visit - 7 days
Non-Ocular Treatment-Emergent Adverse Events
Non-Ocular Treatment-Emergent Adverse Events on the Study Eye
Time frame: 7 days
Clinical Resolution
The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Participants with non-missing data
Time frame: Day 8 (Visit 2)
Clinical Resolution
The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.
Time frame: Day 11 (Visit 3)
Microbial Eradication
The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.
Time frame: Days 8 (Visit 2)
Microbial Eradication
The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.
Time frame: Days 11 (Visit 3)
Microbial Outcome With Clinical Resolution
At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline
Time frame: Day 8 (Visit 2)
Microbial Outcome With Clinical Resolution
At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline
Time frame: Day 11 (Visit 3)
Individual Clinical Outcomes - Ocular Discharge
ocular conjunctival discharge measured as absent, mild, moderate or severe
Time frame: At day 1 (Vist 1)
Individual Clinical Outcomes - Ocular Discharge
ocular conjunctival discharge measured as absent, mild, moderate or severe
Time frame: At day 8 (Vist 2)
Individual Clinical Outcomes - Ocular Discharge
ocular conjunctival discharge measured as absent, mild, moderate or severe
Time frame: At day 11 (Vist 3)
Individual Clinical Outcomes - Bulbar Injection
Bulbar conjunctival injection measured as normal, mild, moderate or severe
Time frame: At day 1 (Vist 1)
Individual Clinical Outcomes - Bulbar Injection
Bulbar conjunctival injection measured as normal, mild, moderate or severe
Time frame: At day 8 (Vist 2)
Individual Clinical Outcomes - Bulbar Injection
Bulbar conjunctival injection measured as normal, mild, moderate or severe
Time frame: At day 11 (Vist 3)
First participant entered the study 6/22/2010 and the last participant visit was 12/12/2011. Twenty four sites in the United States participated in the study.
| Milestone | Besivance | Vehicle |
|---|---|---|
| Started | 347 | 171 |
| Modified intent to treat population | 212 | 87 |
| Safety population | 344 | 170 |
| Completed | 335 | 161 |
| Not completed | 12 | 10 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Adverse event | 4 | 0 |
| Withdrew: Physician decision | 1 | 4 |
| Withdrew: Lack of efficacy | 1 | 1 |
| Withdrew: Residual bacterial conjunctivitis | 1 | 0 |
| Withdrew: Treated not as randomized | 3 | 2 |
| Withdrew: Herpes simplex dermatitis | 1 | 0 |
| Withdrew: Protocol violation | 0 | 1 |
Ocular Treatment-Emergent Adverse Events on the Study Eye
| Events | Besivance | Vehicle |
|---|---|---|
| Conjunctivitis | 3 (0.2 to 3) | 3 (0.4 to 5.1) |
| Blepharitis | 1 (0.0 to 1.6) | 1 (0.0 to 3.2) |
| Conjunctival Oedema | 1 (0.0 to 1.6) | 1 (0.0 to 3.2) |
| Erythema of Eyelid | 2 (0.1 to 2.1) | 0 (0.0 to 0.0) |
| Punctate Keratitis | 1 (0.0 to 1.6) | 1 (0.0 to 3.2) |
| Conjunctival Haemorrhage | 1 (0.0 to 1.6) | 0 (0.0 to 0.0) |
| Conjunctivitis Allergic | 0 (0.0 to 0.0) | 1 (0.0 to 3.2) |
| Corneal Infiltrates | 1 (0.0 to 1.6) | 0 (0.0 to 0.0) |
| Dacryocystitis | 1 (0.0 to 1.6) | 0 (0.0 to 0.0) |
| Eye Pain | 1 (0.0 to 1.6) | 0 (0.0 to 0.0) |
| Lacrimation Increased | 1 (0.0 to 1.6) | 0 (0.0 to 0.0) |
| Scleritis | 0 (0.0 to 0.0) | 1 (0.0 to 3.2) |
| Instillation Site Reaction | 2 (0.1 to 2.1) | 1 (0.0 to 3.2) |
| Instillation Site Erythema | 1 (0.0 to 1.6) | 0 (0.0 to 0.0) |
| Instillation Site Irritation | 0 (0.0 to 0.0) | 1 (0.0 to 3.2) |
| Instillation Site Pain | 1 (0.0 to 1.6) | 0 (0.0 to 0.0) |
| Pain | 0 (0.0 to 0.0) | 1 (0.0 to 3.2) |
| Herpes Dermatitis | 1 (0.0 to 1.6) | 0 (0.0 to 0.0) |
| Post-Traumatic Pain | 0 (0.0 to 0.0) | 1 (0.0 to 3.2) |
| Corneal Staining | 1 (0.0 to 1.6) | 0 (0.0 to 0.0) |
The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Participants with non-missing data
| eyes | Besivance | Vehicle |
|---|---|---|
| Clinical Resolution | 112 | 46 |
The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.
| eyes | Besivance | Vehicle |
|---|---|---|
| Clinical Resolution | 169 | 68 |
The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.
| eyes | Besivance | Vehicle |
|---|---|---|
| Microbial Eradication | 172 | 36 |
The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.
| eyes | Besivance | Vehicle |
|---|---|---|
| Microbial Eradication | 169 | 48 |
Non-Ocular Treatment-Emergent Adverse Events on the Study Eye
| Events | Besivance | Vehicle |
|---|---|---|
| Ear Pain | 1 (0.0 to 1.6) | 0 (0.0 to 0.0) |
| Dysgeusia | 1 (0.0 to 1.6) | 0 (0.0 to 0.0) |
| Pyrexia | 1 (0.0 to 1.6) | 0 (0.0 to 0.0) |
| Nasopharyngitis | 2 (0.1 to 2.1) | 1 (0.0 to 3.2) |
| Bronchitis | 0 (0.0 to 0.0) | 1 (0.0 to 3.2) |
| Gastroenteritis, Viral | 0 (0.0 to 0.0) | 1 (0.0 to 3.2) |
| Otitis Media | 1 (0.0 to 1.6) | 0 (0.0 to 0.0) |
| Upper Respiratory Tract Infection | 1 (0.0 to 1.6) | 0 (0.0 to 0.0) |
At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline
| eyes | Besivance | Vehicle |
|---|---|---|
| Clinical Resolution with Microbial Eradication | 96 | 22 |
| Clinical Resolution with no Microbial Eradication | 16 | 24 |
| No Clinical Resolution with Microbial Eradication | 76 | 14 |
| No Clinical Resolution no Microbial Eradication | 18 | 20 |
At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline
| eyes | Besivance | Vehicle |
|---|---|---|
| Clinical Resolution with Microbial Eradication | 143 | 42 |
| Clinical Resolution with no Microbial Eradication | 23 | 25 |
| No Clinical Resolution with Microbial Eradication | 26 | 6 |
| No Clinical Resolution no Microbial Eradication | 8 | 10 |
ocular conjunctival discharge measured as absent, mild, moderate or severe
| eyes | Besivance | Vehicle |
|---|---|---|
| Absent | 0 | 0 |
| Mild | 94 | 38 |
| Moderate | 106 | 44 |
| Severe | 12 | 5 |
ocular conjunctival discharge measured as absent, mild, moderate or severe
| eyes | Besivance | Vehicle |
|---|---|---|
| Absent | 155 | 61 |
| Mild | 42 | 18 |
| Moderate | 8 | 4 |
| Severe | 1 | 0 |
ocular conjunctival discharge measured as absent, mild, moderate or severe
| eyes | Besivance | Vehicle |
|---|---|---|
| Absent | 187 | 77 |
| Mild | 12 | 6 |
| Moderate | 4 | 1 |
| Severe | 1 | 0 |
Bulbar conjunctival injection measured as normal, mild, moderate or severe
| eyes | Besivance | Vehicle |
|---|---|---|
| Normal | 0 | 0 |
| Mild | 110 | 44 |
| Moderate | 83 | 37 |
| Severe | 19 | 6 |
Bulbar conjunctival injection measured as normal, mild, moderate or severe
| eyes | Besivance | Vehicle |
|---|---|---|
| Normal | 142 | 57 |
| Mild | 56 | 23 |
| Moderate | 7 | 3 |
| Severe | 1 | 0 |
Bulbar conjunctival injection measured as normal, mild, moderate or severe
| eyes | Besivance | Vehicle |
|---|---|---|
| Normal | 182 | 72 |
| Mild | 18 | 11 |
| Moderate | 4 | 1 |
| Severe | 0 | 0 |
Collected over 11 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Besivance | — | 0/347 (0%) | 0/347 (0%) |
| Vehicle | — | 0/171 (0%) | 0/171 (0%) |
Intent to treat population (ITT)
| Age, Customized(participants) | Besivance | Vehicle | Total |
|---|---|---|---|
| 0-17 years | 149 | 62 | 211 |
| 18 - 49 years | 106 | 71 | 177 |
| >=50 years | 92 | 38 | 130 |
| Sex: Female, Male(Participants) | Besivance | Vehicle | Total |
|---|---|---|---|
| Female | 205 | 95 | 300 |
| Male | 142 | 76 | 218 |
| Race (NIH/OMB)(Participants) | Besivance | Vehicle | Total |
|---|---|---|---|
| American Indian or Alaska Native | 7 | 3 | 10 |
| Asian | 5 | 5 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 83 | 40 | 123 |
| White | 213 | 103 | 316 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 39 | 19 | 58 |
The record gives a start of Jun 2010, a primary completion of Dec 2011 and a completion of Feb 2012. It does not say whether these dates are actual or estimated.
Results were first posted in May 2013, 1 year 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Besifloxacin