A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.

Acute Bacterial Conjunctivitis Clinical Trial

Official title:

A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vehicle in the Treatment of Bacterial Conjunctivitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00347932
• Other study ID #: 433
• Secondary ID: BOL-303224
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2006
• Last updated: March 4, 2015
• Start date: June 2006
• Est. completion date: November 2007

Study information

• Verified date: March 2015
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 957
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.

• Females of childbearing potential must utilized reliable contraceptive methods and have a negative pregnancy test.

Exclusion Criteria:

• Pregnant or nursing females.

• Known hypersensitivity to fluoroquinolones or to any of the study ingredients.

• Use of any antibiotic within 72 hours of treatment.

• Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications.

• Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Bacterial Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Bacterial

Intervention

Drug:
• ISV-403
Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days.
• Vehicle
Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (TID) for 5 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Resolution of Baseline Bacterial Conjunctivitis	The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection	Day 5 +/- 1 day	No
Primary	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.	Day 5 +/- 1 day	No
Secondary	Clinical Resolution of Baseline Bacterial Conjunctivitis	The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection	Day 8 or 9	No
Secondary	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.	Day 8 or 9	No