Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis

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

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

Study Overview

• Status: Completed
• Conditions: Bacterial Conjunctivitis
• Intervention / Treatment: Drug: ISV-403; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ISV-403; ISV-403 0.6%	Drug: ISV-403; 0.6% TID, 5 days; Other Names: besifloxacin
Placebo Comparator: Vehicle; Vehicle of ISV-403	Drug: Vehicle; Vehicle of ISV-403 TID, 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9)	Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.	Visit 3 - day 8 or 9
Eradication of Baseline Pathogens (Day 8 or 9)	Bacterial species eradication of baseline bacterial infection	Visit 3 - Day 8 or day 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day)	The absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.	Visit 2 - Day 4 (+/- 1 day)
Eradication of Baseline Pathogens Day 4 (+/- 1 Day)	Bacterial species eradication of baseline bacterial infection	Visit 2 - Day 4 (+/- 1 day)

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): June 1, 2005
• Study Completion (Actual): June 1, 2005

Study Registration Dates

• First Submitted: February 14, 2008
• First Submitted That Met QC Criteria: February 14, 2008
• First Posted (Estimate): February 25, 2008

Study Record Updates

• Last Update Posted (Estimate): March 24, 2015
• Last Update Submitted That Met QC Criteria: March 4, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Eye Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Conjunctival Diseases; Eye Infections, Bacterial; Eye Infections; Conjunctivitis; Conjunctivitis, Bacterial; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Besifloxacin
• Other Study ID Numbers: 373 (Italian RSO http://osservazionali.agenziafarmaco.it)