Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis

NCT00622908 | Completed Phase 2 Results

• 1 other identifier: 373
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day)

  Visit 2 - Day 4 (+/- 1 day)

• Eradication of Baseline Pathogens Day 4 (+/- 1 Day)

  Visit 2 - Day 4 (+/- 1 day)

Study Arms (2)

ISV-403

EXPERIMENTAL

ISV-403 0.6%

Drug: ISV-403

Vehicle

PLACEBO COMPARATOR

Vehicle of ISV-403

Drug: Vehicle

Interventions

ISV-403 DRUG

0.6% TID, 5 days

Also known as: besifloxacin

ISV-403

Vehicle DRUG

Vehicle of ISV-403 TID, 5 days

Vehicle

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Related Publications (3)

• 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.

  PMID: 32841261 DERIVED

• 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.

  PMID: 20629472 DERIVED

• 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.

  PMID: 19393842 DERIVED

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Interventions

besifloxacin

Condition Hierarchy (Ancestors)

Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Results Point of Contact

• Title: Timothy Comstock
• Organization: Bausch & Lomb Incorporated

timothy.comstock@bausch.com

(585) 338-6631

Study Officials

• Timothy Comstock, OD

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 25, 2008
• Study Start: December 1, 2004
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: March 24, 2015
• Results First Posted: August 13, 2009

Record last verified: 2015-03