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Completed

NCT Number: NCT01027013

Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye

The purpose of this study is to evaluate the safety and efficacy of rebamipide 2% suspension for the treatment of patients with dry-eye.

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Key information

Conditions

Dry Eye Syndromes Conjunctival Diseases Conjunctivitis Corneal Diseases Eye Diseases Keratitis Keratoconjunctivitis Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Eye Care Group, P.C., Waterbury, Connecticut, 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

  • Age 18 years and older
  • Diagnosis of dry eye as defined by the protocol

Exclusion criteria

  • Ongoing ocular disease that may interfere with study parameters.
  • Inability to stop using topical ophthalmic medications throughout the duration of the study
  • Inability to stop the use of contact lenses for the duration of the study.

Treatment and study plan

rebamipide 2% ophthalmic suspension

Drug

Instill one drop in each eye four times daily for 12 weeks.

Placebo Eye Drops

Drug

Instill one drop in each eye four times daily for 12 weeks.

Primary outcomes

  1. Total fluorescein corneal staining score

    Time frame: 4 weeks

  2. Primary ocular discomfort

    Time frame: 4 weeks

Secondary outcomes

  1. Dry eye symptoms

    Time frame: 12 weeks

  2. Ocular staining

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Kubota Vision Inc.

Industry

Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study title

A Phase II, Prospective, Randomized, Double-masked, Parallel Group, Multi-center Study Assessing the Safety and Efficacy of 2% Rebamipide (OPC-12759) Compared to Placebo for the Treatment of Keratoconjunctivitis Sicca (Dry Eye)

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 7, 2009
Registry last updated
Jan 11, 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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