Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome

Dry Eye Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01632137
• Other study ID #: ACU-RED-301
• Status: Completed
• Phase: Phase 3
• First received: June 28, 2012
• Last updated: April 17, 2014
• Start date: June 2012

Study information

• Verified date: April 2014
• Source: Acucela Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 564
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• Rebamipide 2% ophthalmic suspension
Instill one drop into each eye 4 times a day for 4 weeks.
• Placebo (vehicle)
Instill one drop into each eye 4 times a day for 4 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Acucela Inc.	Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary ocular sign: Fluorescein corneal staining total score		4 weeks	No
Primary	Primary ocular symptom: Worst ocular symptom severity score		4 weeks	No
Secondary	Fluorescein corneal staining total score		2 weeks	No
Secondary	Worst ocular symptom severity score		2 weeks	No