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

Seasonal Allergic Conjunctivitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435460
• Other study ID #: 634
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2011
• Last updated: February 17, 2012
• Start date: August 2010
• Est. completion date: May 2011

Study information

• Verified date: February 2012
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic
• Seasonal Allergic Conjunctivitis

Intervention

Drug:
• Loteprednol etabonate 0.2%
1 drop of Alrex 4 times daily (QID) in both eyes at approximately 4 hour intervals for 2 weeks.
• Olopatadine 0.1%
1 drop of Patanol 2 times daily (BID)at intervals of 6-8 hours or more for 2 weeks.

Locations

Country	Name	City	State
Singapore	Bausch & Lomb Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bulbar Conjunctival Injection	Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe	Change from baseline to day 15 (visit 3)	No
Primary	Ocular Itching	Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe	Change from baseline to day 15 (visit 3)	No
Secondary	Bulbar Conjunctival Injection	Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe	Change from baseline to day 8 (visit 2)	No
Secondary	Ocular Itching	Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe	Change from baseline to day 8 (visit 2)	No