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

NCT ID: NCT01435460

Last Updated: 2012-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-05-31

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).

Conditions

Seasonal Allergic Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Alrex

Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%

Group Type: EXPERIMENTAL

Loteprednol etabonate 0.2%

Intervention Type: DRUG

1 drop of Alrex 4 times daily (QID) in both eyes at approximately 4 hour intervals for 2 weeks.

Patanol

Ophthalmic solution containing olopatadine, 0.1%

Group Type: ACTIVE_COMPARATOR

Olopatadine 0.1%

Intervention Type: DRUG

1 drop of Patanol 2 times daily (BID)at intervals of 6-8 hours or more for 2 weeks.

Interventions

Loteprednol etabonate 0.2%

1 drop of Alrex 4 times daily (QID) in both eyes at approximately 4 hour intervals for 2 weeks.

Intervention Type: DRUG

Olopatadine 0.1%

1 drop of Patanol 2 times daily (BID)at intervals of 6-8 hours or more for 2 weeks.

Intervention Type: DRUG

Other Intervention Names

Alrex; Patanol

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Esther Chu

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Bausch & Lomb Singapore

Singapore, Singapore, Singapore

Countries

Singapore

References

Gong L, Sun X, Qu J, Wang L, Zhang M, Zhang H, Wang L, Gu Y, Elion-Mboussa A, Roy L, Zhu B. Loteprednol etabonate suspension 0.2% administered QID compared with olopatadine solution 0.1% administered BID in the treatment of seasonal allergic conjunctivitis: a multicenter, randomized, investigator-masked, parallel group study in Chinese patients. Clin Ther. 2012 Jun;34(6):1259-1272.e1. doi: 10.1016/j.clinthera.2012.04.024. Epub 2012 May 23.

Reference Type: DERIVED

PMID: 22627057 (View on PubMed)

Other Identifiers

634

Identifier Type: -

Identifier Source: org_study_id