Back to resultsA Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.
Primary Purpose
Acute Bacterial Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ISV-403
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Acute Bacterial Conjunctivitis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ISV-403
Vehicle
Arm Description
0.6% ISV-403 ophthalmic suspension
Vehicle of ISV-403 ophthalmic suspension
Outcomes
Primary Outcome Measures
Clinical Resolution of Baseline Bacterial Conjunctivitis
The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
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.
Secondary Outcome Measures
Clinical Resolution of Baseline Bacterial Conjunctivitis
The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
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.
Full Information
NCT ID
NCT00347932
First Posted
June 30, 2006
Last Updated
March 4, 2015
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00347932
Brief Title
A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bacterial Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
957 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ISV-403
Arm Type
Experimental
Arm Description
0.6% ISV-403 ophthalmic suspension
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle of ISV-403 ophthalmic suspension
Intervention Type
Drug
Intervention Name(s)
ISV-403
Other Intervention Name(s)
besifloxacin, Besivance, BOL-303224
Intervention Description
Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (TID) for 5 days.
Primary Outcome Measure Information:
Title
Clinical Resolution of Baseline Bacterial Conjunctivitis
Description
The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
Time Frame
Day 5 +/- 1 day
Title
Microbial Eradication of Baseline Bacterial Infection
Description
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
Secondary Outcome Measure Information:
Title
Clinical Resolution of Baseline Bacterial Conjunctivitis
Description
The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
Time Frame
Day 8 or 9
Title
Microbial Eradication of Baseline Bacterial Infection
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Trusso
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
32841261
Citation
DeCory HH, Sanfilippo CM, Proskin HM, Blondeau JM. Characterization of baseline polybacterial versus monobacterial infections in three randomized controlled bacterial conjunctivitis trials and microbial outcomes with besifloxacin ophthalmic suspension 0.6. PLoS One. 2020 Aug 25;15(8):e0237603. doi: 10.1371/journal.pone.0237603. eCollection 2020.
Results Reference
derived
PubMed Identifier
20629472
Citation
Comstock TL, Paterno MR, Decory HH, Usner DW. Safety and tolerability of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis: data from six clinical and phase I safety studies. Clin Drug Investig. 2010;30(10):675-85. doi: 10.2165/11536720-000000000-00000.
Results Reference
derived
PubMed Identifier
19323612
Citation
Tepedino ME, Heller WH, Usner DW, Brunner LS, Morris TW, Haas W, Paterno MR, Comstock TL. Phase III efficacy and safety study of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis. Curr Med Res Opin. 2009 May;25(5):1159-69. doi: 10.1185/03007990902837919.
Results Reference
derived
Learn more about this trial
A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.
We'll reach out to this number within 24 hrs