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Alrex� Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)

Information source: Bausch & Lomb Incorporated
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Seasonal Allergic Conjunctivitis

Intervention: Loteprednol etabonate 0.2% (Drug); Olopatadine 0.1% (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bausch & Lomb Incorporated

Official(s) and/or principal investigator(s):
Esther Chu, Study Director, Affiliation: Bausch & Lomb Incorporated

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).

Clinical Details

Official title: A Clinical Safety and Efficacy Evaluation of Alrex (Loteprednol Etabonate Ophthalmic Suspension, 0.2%) Versus Patanol (Olopatadine Hydrochloride Ophthalmic Solution, 0.1%) in the Treatment of Seasonal Allergic Conjunctivitis (SAC)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome:

Bulbar Conjunctival Injection

Ocular Itching

Secondary outcome:

Bulbar Conjunctival Injection

Ocular Itching

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Bausch & Lomb Singapore, Singapore 556741, Singapore
Additional Information

Starting date: August 2010
Last updated: February 17, 2012

Page last updated: August 23, 2015

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