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Completed

NCT Number: NCT00534794

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

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

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Elestat

Drug

Elestat BID for 2 days

Pataday

Drug

Pataday QD for 2 days

Primary outcomes

  1. Change in Ocular Itch Score From Baseline

    Time frame: 0 hours, 12 hours

    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.

Secondary outcomes

  1. Ocular Comfort Score at 12 Hours

    Time frame: 12 hours

    Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
First posted
Sep 26, 2007
Registry last updated
May 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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