Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis
Primary Purpose
Bacterial Conjunctivitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ISV-403
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- Must be at least one year of age.
- Must have signature of subject or legally authorized representative (if subject is under 18 years of age) on the informed Consent Form.
- Must have signature of subject on the Assent Form if subject is 6 to 17 years of age.
- Must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least one eye. A minimum score of 1 should be present for discharge and a minimum score of 1 for either bulbar or palpebral conjunctival injection.
- Must have pinholed visual acuity equal to or better than 20/200 in both eyes. Age appropriate visual acuity testing was to be performed. Every effort was made to obtain a visual acuity measurement in children. If visual acuity was unobtainable in children, it was at the investigator's discretion to meet inclusion criteria.
- Must be willing to discontinue contact lens wear for the duration of the study.
- Must be willing to avoid disallowed medications during the study period.
- Must understand the scope of the study including completion of diary, be willing to follow instructions, and be able to make all required study visits.
- If a subject was a female of childbearing potential, she must utilize reliable contraceptive methods and have a negative pregnancy test.
Exclusion Criteria:
- Any uncontrolled systemic disease or debilitating disease.
- Use of topical ophthalmic solutions including tear substitutes within two hours before and during the study.
- Use of any ophthalmic topical anti-inflammatory agents within 48 hours before and during the study.
- Subjects likely to require antimicrobial therapy with any active respiratory tract infection, urinary tract infection, skin/soft tissue infection, or otitis media.
- Pregnant or nursing females.
- Known hypersensitivity to SS734 or to any of the ingredients in the study medications.
- Known hypersensitivity to fluoroquinolones or to any of the ingredients in the study medications.
- Ocular surgery (including laser surgery) in either eye within the past six weeks.
- Subjects with suspected viral or allergic conjunctivitis (i.e., severe itching or acute follicular conjunctivitis), or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication.
- Subjects with suspected iritis (i.e., smaller pupil, pain, and photophobia in infected eye).
- History of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome.
- Use of any antibiotic within 72 hours of enrollment.
- Any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis
- Participation in an ophthalmic drug or device research study within the 30 days prior to entry in this study.
- Subjects who were immune compromised.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ISV-403
Vehicle
Arm Description
ISV-403 0.6%
Vehicle of ISV-403
Outcomes
Primary Outcome Measures
Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9)
Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.
Eradication of Baseline Pathogens (Day 8 or 9)
Bacterial species eradication of baseline bacterial infection
Secondary Outcome Measures
Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day)
The absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.
Eradication of Baseline Pathogens Day 4 (+/- 1 Day)
Bacterial species eradication of baseline bacterial infection
Full Information
NCT ID
NCT00622908
First Posted
February 14, 2008
Last Updated
March 4, 2015
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00622908
Brief Title
Clinical and Microbial Efficacy of ISV403 in 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
December 2004 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (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
To evaluate the clinical and microbial efficacy of ISV-403 administered three times a day (TID) for 5 days compared to vehicle three times a day for 5 days 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
Bacterial Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ISV-403
Arm Type
Experimental
Arm Description
ISV-403 0.6%
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle of ISV-403
Intervention Type
Drug
Intervention Name(s)
ISV-403
Other Intervention Name(s)
besifloxacin
Intervention Description
0.6% TID, 5 days
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Vehicle of ISV-403 TID, 5 days
Primary Outcome Measure Information:
Title
Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9)
Description
Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.
Time Frame
Visit 3 - day 8 or 9
Title
Eradication of Baseline Pathogens (Day 8 or 9)
Description
Bacterial species eradication of baseline bacterial infection
Time Frame
Visit 3 - Day 8 or day 9
Secondary Outcome Measure Information:
Title
Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day)
Description
The absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.
Time Frame
Visit 2 - Day 4 (+/- 1 day)
Title
Eradication of Baseline Pathogens Day 4 (+/- 1 Day)
Description
Bacterial species eradication of baseline bacterial infection
Time Frame
Visit 2 - Day 4 (+/- 1 day)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be at least one year of age.
Must have signature of subject or legally authorized representative (if subject is under 18 years of age) on the informed Consent Form.
Must have signature of subject on the Assent Form if subject is 6 to 17 years of age.
Must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least one eye. A minimum score of 1 should be present for discharge and a minimum score of 1 for either bulbar or palpebral conjunctival injection.
Must have pinholed visual acuity equal to or better than 20/200 in both eyes. Age appropriate visual acuity testing was to be performed. Every effort was made to obtain a visual acuity measurement in children. If visual acuity was unobtainable in children, it was at the investigator's discretion to meet inclusion criteria.
Must be willing to discontinue contact lens wear for the duration of the study.
Must be willing to avoid disallowed medications during the study period.
Must understand the scope of the study including completion of diary, be willing to follow instructions, and be able to make all required study visits.
If a subject was a female of childbearing potential, she must utilize reliable contraceptive methods and have a negative pregnancy test.
Exclusion Criteria:
Any uncontrolled systemic disease or debilitating disease.
Use of topical ophthalmic solutions including tear substitutes within two hours before and during the study.
Use of any ophthalmic topical anti-inflammatory agents within 48 hours before and during the study.
Subjects likely to require antimicrobial therapy with any active respiratory tract infection, urinary tract infection, skin/soft tissue infection, or otitis media.
Pregnant or nursing females.
Known hypersensitivity to SS734 or to any of the ingredients in the study medications.
Known hypersensitivity to fluoroquinolones or to any of the ingredients in the study medications.
Ocular surgery (including laser surgery) in either eye within the past six weeks.
Subjects with suspected viral or allergic conjunctivitis (i.e., severe itching or acute follicular conjunctivitis), or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication.
Subjects with suspected iritis (i.e., smaller pupil, pain, and photophobia in infected eye).
History of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome.
Use of any antibiotic within 72 hours of enrollment.
Any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis
Participation in an ophthalmic drug or device research study within the 30 days prior to entry in this study.
Subjects who were immune compromised.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Comstock, OD
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
19393842
Citation
Karpecki P, Depaolis M, Hunter JA, White EM, Rigel L, Brunner LS, Usner DW, Paterno MR, Comstock TL. Besifloxacin ophthalmic suspension 0.6% in patients with bacterial conjunctivitis: A multicenter, prospective, randomized, double-masked, vehicle-controlled, 5-day efficacy and safety study. Clin Ther. 2009 Mar;31(3):514-26. doi: 10.1016/j.clinthera.2009.03.010.
Results Reference
derived
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Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis
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