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Completed

NCT Number: NCT00370747

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

Primary location

Irvine, California, 92618, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male/female at least 18 years of age
  • Agree to avoid disallowed medications
  • Have a diagnosis of dry eye

Exclusion criteria

  • Have chronic systemic inflammation
  • Have active seasonal ocular allergies

Treatment and study plan

Ecabet

Drug

ophthalmic solution 2.83%

Placebo

Drug

Primary outcomes

  1. Ocular signs and Symptoms

    Time frame: 90 days

    ocular signs, including corneal and conjunctival staining, tear film breakup time and blink rate, and ocular symptoms, including burning or stinging, itchiness or scratchiness, grittiness or sandiness, foreign body sensation, haziness or blurriness, photophobia, photopsia, and eye discomfort

Secondary outcomes

  1. Ocular Surface Disease Index (OSDI)

    Time frame: 90 days

    Questionaire

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

Efficacy and Safety of Ecabet Ophthalmic Solution for the Treatment of Dry Eye Syndrome

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 1, 2006
Registry last updated
Mar 15, 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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