A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis

NCT00348348 | Completed Phase 3 Results

• 1 other identifier: 434
• Study Type: interventional
• Target: 1,161
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a study to investigate a novel drug candidate for the treatment of bacterial conjunctivitis.

Conditions

Acute Bacterial Conjunctivitis

Outcome Measures

Primary Outcomes (2)

• Clinical Resolution

  Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)

  Day 5(+/- 1 day)

• Microbial Eradication

  eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated

  Day 5 (+/- 1 day)

Secondary Outcomes (2)

• Clinical Resolution

  Day 8 or Day 9

• Microbial Eradication

  Day 8 or Day 9

Study Arms (2)

Moxifloxacin solution

ACTIVE COMPARATOR

Moxifloxacin hydrochloride ophthalmic solution 0.5%

Drug: Moxifloxacin solution

Besifloxacin Suspension

EXPERIMENTAL

Besifloxacin hydrochloride ophthalmic suspension 0.6%

Drug: Besifloxacin

Interventions

Besifloxacin DRUG

Besifloxacin hydrochloride ophthalmic suspension, 0.6% as base, administered TID for 5 days

Besifloxacin Suspension

Moxifloxacin solution DRUG

Moxifloxacin hydrochloride ophthalmic solution 0.5% administered TID for 5 days.

Moxifloxacin solution

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:

• Clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.

You may not qualify if:

• Pregnant or nursing females.
• Use of any antibiotic within 72 hours of enrollment.
• Any disease conditions that could interfere with the safety and efficacy evaluations of the study drug.
• Participation in an ophthalmic drug or device research study within 30 days prior to entry into this study.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Related Publications (2)

• 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

MeSH Terms

Interventions

besifloxacin

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 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2006
• First Posted: July 4, 2006
• Study Start: June 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: March 24, 2015
• Results First Posted: August 13, 2009

Record last verified: 2015-03