Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine the safety and effectiveness of hydrocortisone ophthalmic ointment compared to placebo in the treatment of Allergic Conjunctivitis.


Clinical Trial Description

Compare the safety and efficacy of Hydrocortisone Ophthalmic Ointment 0.5% vs. Placebo for the reduction of signs and symptoms associated with allergic conjunctivitis. Demonstration of efficacy is a statistically significant improvement in itching on a 0 to 4 patient subjective assessment itch score compared to the vehicle arm and at least a 25% (or 1 full unit or more) improvement in itch scores. Efficacy for bulbar redness scores would be indicated by a statistically significant improvement in redness on a zero to 4 based on the investigators objective assessment compared to the vehicle group. Differences of at least 25% on the four point scale would be considered clinically significant when attained at the majority of time points. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01860664
Study type Interventional
Source Koffler Vision Group
Contact
Status Terminated
Phase Phase 2
Start date May 2013
Completion date January 1, 2017

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 NCT01697969 - Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients Phase 4
Completed NCT01685242 - A Single-Center,Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle Phase 3
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 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