Clinical Trials Logo
  1. Home
  2. Allergic Conjunctivitis
  3. NCT00423007
  4. Details
NCT00423007 Clinical Trial

Efficacy and Safety of Topical Bromfenac Ophthalmic Solution vs. Placebo in Subjects With Allergic Conjunctivitis

Allergic Conjunctivitis Clinical Trial

Official title:
Efficacy and Safety of Topical Bromfenac Ophthalmic Solution vs. Placebo in Subjects With a History of Allergic Conjunctivitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00423007
Other study ID # ISTA-BR-CS03
Secondary ID
Status Completed
Phase Phase 3
First received January 15, 2007
Last updated March 13, 2013
Start date November 2006
Est. completion date August 2007

Study information
Verified date March 2013
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 10 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Bromfenac

• Placebo

Locations
Country Name City State
United States ISTA Pharmaceuticals, Inc. Irvine California

Sponsors (1)
Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment of ocular itching No
Secondary Treatment of chemosis, episcleral and ciliary hyperemia, ocular mucous discharge, eyelid swelling, foreign body sensation, nasal symptoms, and/or tearing No
See also
  Status Clinical Trial Phase
Completed NCT03660878 - A Methodology Development Environmental Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis Phase 1/Phase 2
Completed NCT03682965 - Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study Phase 2
Completed NCT01685242 - A Single-Center,Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle Phase 3
Completed NCT01697969 - Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients Phase 4
Completed NCT01439815 - An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo Phase 4
Completed NCT01294969 - Patient Perception Study for AL-4943A Phase 4
Completed NCT01471184 - The Effects of Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops Compared to Placebo Phase 1
Completed NCT00609128 - Effect of Olopatadine on Allergic Tear Mediators N/A
Recruiting NCT05969236 - A Study of MDI-1228_mesylate Ophthalmic Solution in Healthy Adults Phase 1
Active, not recruiting NCT04619017 - Airway Immune Response to Allergens (Use Lay Language Here) Phase 1
Not yet recruiting NCT01012752 - A Multicenter Study to Evaluate Safety and Efficacy of Specific Immunotherapy With Modified Allergen Extracts Phase 3
Completed NCT01698814 - A Six-Week Safety Study of an Investigational Ophthalmic Solution Phase 3
Completed NCT01754766 - AGN-229666 for the Treatment of Allergic Conjunctivitis Phase 2
Completed NCT01443442 - Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis Phase 4
Completed NCT01203540 - Evaluation of the Effect and Tolerance of Preservative Free NAAGA on the Inflammatory Component and Symptoms of Dry Eye Syndrome in Allergic Conjunctivitis Patients Phase 4
Completed NCT00987272 - Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis in Japanese Subjects Phase 3
Completed NCT00769886 - Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis. Phase 3
Completed NCT00534794 - Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis Phase 4
Completed NCT00586625 - Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers Phase 3
Completed NCT00586664 - Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis Phase 3