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OpenTrials
Completed

NCT Number: NCT00893139

A Study of AL-38583 Ophthalmic Solution 0.05%, 0.010% Versus AL-38583 Vehicle for Dry Eye

The purpose of this study is to determine whether AL-38583 ophthalmic solution is effective for treatment of signs and symptoms of dry eye.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Composite corneal staining score of greater than 5 in one or both eyes.
  • Schirmer II score of greater than 4 mm.
  • OSDI score of greater than 23.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude the safe administration of the test article or safe participation in this study.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

AL-38583 ophthalmic solution 0.05%

Drug

AL-38583 ophthalmic solution 0.10%

Drug

AL-38583 vehicle

Drug

Inactive ingredients used as a placebo comparator

Primary outcomes

  1. Mean change from baseline in sodium fluorescein corneal staining score

    Time frame: Baseline, up to Day 35

Secondary outcomes

  1. Mean change from baseline in phenol red thread length

    Time frame: Baseline, up to Day 35

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 5, 2009
Registry last updated
Jul 15, 2014

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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