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

Phase 3

Completed

• Conditions: Seasonal Allergic Conjunctivitis
• Interventions: Drug: Olopatadine 0.1%; Drug: Loteprednol etabonate 0.2%

• Registration Number: NCT01435460
• Lead Sponsor: Bausch & Lomb Incorporated

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2011-04
• Study Completion: 2011-05
• Study First Submitted: 2011-09-14
• Study First Submitted QC: 2011-09-15
• Study First Posted: 2011-09-16
• Status Verified: 2012-02
• Results First Submitted: 2012-02-17
• Results First Submitted QC: 2012-02-17
• Last Update Submitted: 2012-02-17
• Results First Posted: 2012-03-13
• Last Update Posted: 2012-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patanol	Olopatadine 0.1%	Ophthalmic solution containing olopatadine, 0.1%
Alrex	Loteprednol etabonate 0.2%	Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%

Primary Outcome Measures

Name	Time	Method
Bulbar Conjunctival Injection	Change from baseline to day 15 (visit 3)	Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe
Ocular Itching	Change from baseline to day 15 (visit 3)	Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe

Secondary Outcome Measures

Name	Time	Method
Bulbar Conjunctival Injection	Change from baseline to day 8 (visit 2)	Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe
Ocular Itching	Change from baseline to day 8 (visit 2)	Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe

Trial Locations

Locations (1)

Bausch & Lomb Singapore; 🇸🇬 Singapore, Singapore