Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis

NCT ID: NCT00622908

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2005-06-30

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

Conditions

Bacterial Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ISV-403

ISV-403 0.6%

Group Type: EXPERIMENTAL

ISV-403

Intervention Type: DRUG

0.6% TID, 5 days

Vehicle

Vehicle of ISV-403

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Vehicle of ISV-403 TID, 5 days

Interventions

ISV-403

0.6% TID, 5 days

Intervention Type: DRUG

Vehicle

Vehicle of ISV-403 TID, 5 days

Intervention Type: DRUG

Other Intervention Names

besifloxacin

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 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.

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Comstock, OD

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

References

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.

Reference Type: DERIVED

PMID: 32841261 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20629472 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19393842 (View on PubMed)

Other Identifiers

373

Identifier Type: -

Identifier Source: org_study_id