A Phase 3 interventional study of ISV-403 and Vehicle in Acute Bacterial Conjunctivitis, sponsored by Bausch & Lomb Incorporated. Completed. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2015-03-24.
Sponsored by Bausch & Lomb Incorporated (part of Bausch Health Companies Inc.) · Phase 3, Interventional, and Treatment
Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's enrollment of 957 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.
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.
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.
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.
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.
0.6% ISV-403 ophthalmic suspension
Drug: ISV-403
Vehicle of ISV-403 ophthalmic suspension
Drug: Vehicle
Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days.
Also known as: besifloxacin, Besivance, BOL-303224
Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (TID) for 5 days.
Clinical Resolution of Baseline Bacterial Conjunctivitis
The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
Time frame: Day 5 +/- 1 day
Microbial Eradication of Baseline Bacterial Infection
Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.
Time frame: Day 5 +/- 1 day
Clinical Resolution of Baseline Bacterial Conjunctivitis
The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
Time frame: Day 8 or 9
Microbial Eradication of Baseline Bacterial Infection
Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.
Time frame: Day 8 or 9
First subject enrolled 6/5/2006, last patient exited on 11/7/2007. This study was conducted at multiple sites in the US.
| Milestone | ISV-403 | Vehicle |
|---|---|---|
| Started | 475 | 482 |
| Completed | 444 | 430 |
| Not completed | 31 | 52 |
| Withdrew: Adverse event | 4 | 5 |
| Withdrew: Lack of efficacy | 3 | 14 |
| Withdrew: Lost to follow-up | 10 | 9 |
| Withdrew: Withdrawal by subject | 10 | 16 |
| Withdrew: Did not meet inclusion criteria | 4 | 8 |
The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
| Participants | ISV-403 | Vehicle |
|---|---|---|
| Clinical Resolution of Baseline Bacterial Conjunctivitis | 90 | 63 |
Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.
| Participants | ISV-403 | Vehicle |
|---|---|---|
| Microbial Eradication of Baseline Bacterial Infection | 182 | 114 |
The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
| Participants | ISV-403 | Vehicle |
|---|---|---|
| Clinical Resolution of Baseline Bacterial Conjunctivitis | 168 | 132 |
Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.
| Participants | ISV-403 | Vehicle |
|---|---|---|
| Microbial Eradication of Baseline Bacterial Infection | 176 | 137 |
Collected over 8 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ISV-403 | — | 1/442 (0.2%) | 0/741 (0%) |
| Vehicle | — | 1/432 (0.2%) | 0/760 (0%) |
| Event | ISV-403 | Vehicle |
|---|---|---|
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/442 | 1/432 |
| Age, Customized(participants) | ISV-403 | Vehicle | Total |
|---|---|---|---|
| <2 years | 21 | 20 | 41 |
| 2 to 19 years | 196 | 196 | 392 |
| 20 to 59 years | 212 | 226 | 438 |
| >=60 years | 46 | 40 | 86 |
| Sex: Female, Male(Participants) | ISV-403 | Vehicle | Total |
|---|---|---|---|
| Female | 302 | 300 | 602 |
| Male | 173 | 182 | 355 |
| Race/Ethnicity, Customized(Participants) | ISV-403 | Vehicle | Total |
|---|---|---|---|
| Caucasian | 312 | 312 | 624 |
| Asian | 10 | 7 | 17 |
| Black or African American | 44 | 46 | 90 |
| Other | 109 | 117 | 226 |
| Region of Enrollment(participants) | ISV-403 | Vehicle | Total |
|---|---|---|---|
| United States | 475 | 482 | 957 |
No study locations are listed for this record.
The record gives a start of Jun 2006, a primary completion of Nov 2007 and a completion of Nov 2007. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2009, 1 year 9 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 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Besifloxacin