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Completed

NCT Number: NCT01435460

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

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).

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Key information

Conditions

Seasonal Allergic Conjunctivitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bausch & Lomb Singapore

Singapore, 556741

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Loteprednol etabonate 0.2%

Drug

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

Other names: Alrex

Olopatadine 0.1%

Drug

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

Other names: Patanol

Primary outcomes

  1. Bulbar Conjunctival Injection

    Time frame: 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

  2. Ocular Itching

    Time frame: 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 outcomes

  1. Bulbar Conjunctival Injection

    Time frame: 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

  2. Ocular Itching

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 16, 2011
Registry last updated
Mar 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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