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Completed

NCT Number: NCT00198536

Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome

The purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Central Maine Eye Care, Lewiston, Maine, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Agree to avoid systemic & topical ophthalmic meds & disallowed meds
  • Have a best corrected visual acuity (BCVA) of 20/40 with pinhole or better in each eye
  • Diagnosis of moderate dry eye syndrome

Exclusion criteria

  • Uncontrolled ocular or systemic disease that could interfere with study
  • Diagnosis of Sjogren's syndrome, lacrimal obstruction, reflex, lid-related or contact lens-related dry eye syndrome(DES); significant anterior blepharitis or meibomianitis
  • Contraindications or hypersensitivity to use of study meds or components
  • Wear contact lenses
  • Secondary dry eye to surgery
  • Eye surgery (including laser) within 6 months
  • Use of systemic or topical ophthalmic meds within 14 days
  • Punctal plugs in one or both eyes in place for <45 days
  • Permanent occlusion of the lacrimal puncta

Treatment and study plan

Ecabet 2.83%

Drug

Ecabet 3.70%

Drug

Vehicle

Drug

Primary outcomes

  1. Ocular discomfort

    Time frame: Day 91

    Group mean change in ocular discomfort score from pre-Cataract extraction (CAE) to post-CAE

  2. Tear Film Break-up Time (TFBUT)

    Time frame: Day 91

    Group mean change in time to tear break-up from pre-CAE to post-CAE.

  3. Blink Rate

    Time frame: Day 91

    Group mean change in blinks/min from pre-CAE to post-CAE.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

Efficacy and Safety of Ecabet Ophthalmic Solution (2.83% and 3.70%) for Treatment of Dry Eye Syndrome

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Sep 20, 2005
Registry last updated
Mar 14, 2013

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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