Who is sponsoring NCT01435460?

NCT01435460 is sponsored by Bausch & Lomb Incorporated.

What condition does NCT01435460 study?

NCT01435460 studies Seasonal Allergic Conjunctivitis.

What drugs are being tested in NCT01435460?

Interventions: Loteprednol etabonate 0.2%, Olopatadine 0.1%.

What is the status of NCT01435460?

NCT01435460 is currently COMPLETED.

Last reviewed 2012-02-17 · How we verify

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)

NCT01435460 Phase 3 COMPLETED Results posted

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).

Details

Lead sponsor	Bausch & Lomb Incorporated
Phase	Phase 3
Status	COMPLETED
Enrolment	300
Start date	2010-08
Completion	2011-05

Conditions

Seasonal Allergic Conjunctivitis

Interventions

Loteprednol etabonate 0.2%
Olopatadine 0.1%

Primary outcomes

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

Countries

Singapore