Clinical Trials Logo
  1. Home
  2. Allergic Conjunctivitis
  3. NCT00586625
  4. Details
NCT00586625 Clinical Trial

Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers

Allergic Conjunctivitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00586625
Other study ID # CL-SAF-0405071-P
Secondary ID
Status Completed
Phase Phase 3
First received December 21, 2007
Last updated February 13, 2013
Start date October 2007

Study information
Verified date February 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

Safety study for bepotastine besilate ophthalmic solution in normal volunteers

Recruitment information / eligibility
Status Completed
Enrollment 861
Est. completion date
Est. primary completion date May 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Years and older
Eligibility Inclusion Criteria:

- Subjects must be at least 3 years of age, and have ocular health within normal limits

Exclusion Criteria:

- No active ocular disease

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Bepreve
One drop, both eyes, twice a day
• Placebo
One drop, both eyes, twice a day

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Outcome
Type Measure Description Time frame Safety issue
Primary Ocular Comfort A 4-step grading scale with half unit (1-step) increments allowed:
0=Comfortable;discomfort absent; 1.0=Generally comfortable; mild discomfort; 2.0=Some discomfort but tolerable; moderate comfort; 3.0=Severely uncomfortable or intolerable		 Day 8 & Day 22 Yes
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 NCT01754766 - AGN-229666 for the Treatment of Allergic Conjunctivitis Phase 2
Completed NCT01698814 - A Six-Week Safety Study of an Investigational Ophthalmic Solution Phase 3
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 NCT00586664 - Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis Phase 3
Completed NCT00569777 - Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers Phase 3
Completed NCT00534794 - Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis Phase 4