Phase 4
N=79
Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis
Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT00534794 ↗Enrolled (actual)
79
Serious AEs
—
Results posted
May 2009
Primary outcome: Primary: Change in Ocular Itch Score From Baseline — -1.5; -1.5 units on a scale — p=0.532
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Elestat (Drug); Pataday (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Ocular Itch Score From Baseline |
-1.5; -1.5 | 0.532 |
| SECONDARY Ocular Comfort Score at 12 Hours |
8.6; 8.5 | 0.927 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00534794). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.