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

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

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

Study Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Drug: Elestat; Drug: Pataday

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elestat	Drug: Elestat; Elestat BID for 2 days
Active Comparator: Pataday	Drug: Pataday; Pataday QD for 2 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Comfort Score at 12 Hours	Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale.	12 hours

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Michael Raizman, MD, Ophthalmic Consultants of Boston

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: September 20, 2007
• First Submitted That Met QC Criteria: September 21, 2007
• First Posted (Estimate): September 26, 2007

Study Record Updates

• Last Update Posted (Estimate): May 13, 2015
• Last Update Submitted That Met QC Criteria: April 27, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Drug-Related Side Effects and Adverse Reactions; Conjunctivitis; Conjunctivitis, Allergic; Drug Hypersensitivity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Olopatadine Hydrochloride
• Other Study ID Numbers: 031-408