Efficacy and Safety of Topical Bromfenac Ophthalmic Solution vs. Placebo in Subjects With Allergic Conjunctivitis
Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00423007
Collaborator
(none)
90
1
2
9
10
Study Details
Study Description
Brief Summary
The primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment in subjects with a history of allergic conjunctivitis
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Topical Bromfenac Ophthalmic Solution vs. Placebo in Subjects With a History of Allergic Conjunctivitis
Study Start Date
:
Nov 1, 2006
Actual Primary Completion Date
:
Aug 1, 2007
Actual Study Completion Date
:
Aug 1, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bromfenac Ophthalmic Solution |
Drug: Bromfenac
|
| Placebo Comparator: Placebo Vehicle ophthalmic solution |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Treatment of ocular itching []
Secondary Outcome Measures
- Treatment of chemosis, episcleral and ciliary hyperemia, ocular mucous discharge, eyelid swelling, foreign body sensation, nasal symptoms, and/or tearing []
Eligibility Criteria
Criteria
Ages Eligible for Study:
10 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
History of clinically active allergic conjunctivitis
-
Agree to return for all required visits
-
Agree to avoid disallowed meds
Exclusion Criteria:
- Known hypersensitivity to bromfenac and salicylates
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ISTA Pharmaceuticals, Inc. | Irvine | California | United States | 92618 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Study Director: Jon Williams, PhD, ISTA Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00423007
Other Study ID Numbers:
- ISTA-BR-CS03
First Posted:
Jan 17, 2007
Last Update Posted:
Mar 14, 2013
Last Verified:
Mar 1, 2013