Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis

Allergic Conjunctivitis Clinical Trial

Official title:

A Single-Center, Masked, Randomized Study Comparing Two Marketed Ocular Anti-Allergy Medications in the Cat Room Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534794
• Other study ID #: 031-408
• Status: Completed
• Phase: Phase 4
• First received: September 20, 2007
• Last updated: April 27, 2015
• Start date: October 2007

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effects of two marked ocular anti-allergy medications in cat sensitive subjects with allergic conjunctivitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented history of ocular allergy to cats.

• Positive skin prick allergen reaction to cat dander.

Exclusion Criteria:

• Use of any topical or systemic corticosteroids, immunosuppressive agents, antihistamines, decongestants, NSAIDs, or asprin during the two weeks prior to enrollment into the study.

• History of severe asthma, reactive airway disease or bronchial obstruction.

• Ocular surgery or trauma in the last year.

Study Design

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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic
• Drug Hypersensitivity

Intervention

Drug:
• Elestat
Elestat BID for 2 days
• Pataday
Pataday QD for 2 days

Locations

Country	Name	City	State
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Ocular Itch Score From Baseline	Ocular itch was measured on a 0 (none) to 4 (severe itch with continual desire to rub eyes) scale. Negative values for change from baseline represent favorable outcomes.	0 hours, 12 hours	No
Secondary	Ocular Comfort Score at 12 Hours	Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale.	12 hours	No