Phase 3
N=300
Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)
Seasonal Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT01435460 ↗Enrolled (actual)
300
Serious AEs
0.3%
Results posted
Mar 2012
Primary outcome: Primary: Bulbar Conjunctival Injection — -1.91; -1.71 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Loteprednol etabonate 0.2% (Drug); Olopatadine 0.1% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bulbar Conjunctival Injection |
-1.36; -1.18 | — |
| PRIMARY Ocular Itching |
-2.46; -2.02 | — |
| SECONDARY Bulbar Conjunctival Injection |
-1.36; -1.18 | — |
| SECONDARY Ocular Itching |
-2.46; -2.02 | — |
Summary
This study is to evaluate the safety and efficacy of Alrex (LE ophthalmic suspension, 0.2%) versus Patanol (olopatadine hydrochloride ophthalmic solution, 0.1%) in the temporary relief of the signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).
Eligibility Criteria
Inclusion Criteria
- Subjects who are diagnosed with acute SAC and experience at least grade 4 ocular itching and at least grade 2 bulbar conjunctival injection (redness) in each eye due to seasonal allergy at Visit 1.
Exclusion Criteria
- Subjects who have a known hypersensitivity to the study medications or their components or contraindications to ocular corticosteroids.
- Subjects who use any of the disallowed medications throughout the duration of the study and during the period indicated prior to Visit 1.
- Subjects who have intraocular pressure (IOP) greater than 21 mm Hg in either eye or any type of glaucoma.
- Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study or affect the subject's safety or trial parameters.
Data sourced from ClinicalTrials.gov (NCT01435460). 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.