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OpenTrials
Completed

NCT Number: NCT01632137

Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome

The purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic suspension in subjects with dry eye syndrome.

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Phoenix, Arizona, 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

  • History of dry eye-related ocular symptoms for at least 20 months.
  • Meet protocol-defined criteria for corneal and conjunctival staining.
  • Meet protocol-defined criteria for ocular discomfort.

Exclusion criteria

  • Active anterior segment ocular disease other than dry eye syndrome.
  • Inability to suspend the use of topical ophthalmic medications throughout the duration of the study.
  • Inability to suspend the use of contact lenses for the duration of the study.
  • Judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease, or safety concerns.
  • Received any other investigational product within 4 months before the screening visit.

Treatment and study plan

rebamipide 2% ophthalmic suspension

Drug

Instill one drop into each eye 4 times a day for 4 weeks.

Placebo (Vehicle)

Drug

Instill one drop into each eye 4 times a day for 4 weeks.

Primary outcomes

  1. Primary ocular sign: Fluorescein corneal staining total score

    Time frame: 4 weeks

  2. Primary ocular symptom: Worst ocular symptom severity score

    Time frame: 4 weeks

Secondary outcomes

  1. Fluorescein corneal staining total score

    Time frame: 2 weeks

  2. Worst ocular symptom severity score

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Kubota Vision Inc.

Industry

Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study title

A Phase 3 Study to Determine the Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome

Important dates

Study start
2012
Primary completion
2013
First posted
Jul 2, 2012
Registry last updated
May 7, 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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