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Completed

NCT Number: NCT01057147

Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Subjects With Dry Eye - Effects on Central Cornea

The purpose of this study is to evaluate the safety and efficacy of 2% rebamipide compared to placebo in clearing of fluorescein staining of the central cornea in subjects with dry eye disease.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

East Valley Ophthalmology, Mesa, Arizona, United States

Loading trial locations.

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
  • Central corneal staining

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. Central corneal clearing as measured by fluorescein staining

    Time frame: 12 weeks

Secondary outcomes

  1. Ocular staining

    Time frame: 12 weeks

  2. Dry eye symptoms

    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 in Clearing of Fluorescein Staining of the Central Cornea in Subjects With Keratoconjunctivitis Sicca (Dry Eye)

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 27, 2010
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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