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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00534794
Other study ID # 031-408
Secondary ID
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. completion date
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


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
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