Clinical Trials Logo
  1. Home
  2. Dry Eye
  3. NCT01057147
  4. Details
NCT01057147 Clinical Trial

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

Dry Eye Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01057147
Other study ID # ACU-RED-204
Secondary ID
Status Completed
Phase Phase 2
First received January 25, 2010
Last updated January 9, 2012
Start date February 2010
Est. completion date February 2011

Study information
Verified date January 2012
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 safety and efficacy of 2% rebamipide compared to placebo in clearing of fluorescein staining of the central cornea in subjects with dry eye disease.

Recruitment information / eligibility
Status Completed
Enrollment 116
Est. completion date February 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

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

Intervention

Drug:
• rebamipide 2% ophthalmic suspension
Instill one drop in each eye four times daily for 12 weeks.
• placebo eye drops
Instill one drop in each eye four times daily for 12 weeks.

Locations
Country Name City State
United States Ora, Inc. Andover Massachusetts
United States Cohen Laser and Vision Center Boca Raton Florida
United States Florida Eye Microsurgical Institute, Inc. Boynton Beach Florida
United States Mundorf Eye Center Charlotte North Carolina
United States The Cataract & Glaucoma Center El Paso Texas
United States Avista Eye Center Las Vegas Nevada
United States Nevada Eye Care Professionals Las Vegas Nevada
United States Central Maine Eye Care Lewiston Maine
United States Corneal Consultants of Colorado Littleton Colorado
United States Macy Eye Center Los Angeles California
United States George R. John, MD Louisville Kentucky
United States New York Ophthalmology, PC Manhasset New York
United States East Valley Ophthalmology Mesa Arizona
United States Med Eye Associates Miami Florida
United States Specialty Eye Care Parker Colorado
United States Arizona Center for Clinical Trials, LLC Phoenix Arizona
United States Cornea Consultants of Arizona Phoenix Arizona
United States Black Hills Regional Eye Institute Rapid City South Dakota
United States Ophthalmology Associates St. Louis Missouri

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 Central corneal clearing as measured by fluorescein staining 12 weeks No
Secondary Ocular staining 12 weeks No
Secondary Dry eye symptoms 12 weeks No
See also
  Status Clinical Trial Phase
Completed NCT05027087 - The Effect of a Novel Blueberry Supplement on Dry Eye Disease Phase 3
Completed NCT05102409 - An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease Phase 2
Completed NCT06159569 - Performance and Tolerability of the Medical Device LACRIACT N/A
Completed NCT04081610 - Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution Phase 1
Completed NCT05062564 - Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye N/A
Completed NCT05825599 - PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms N/A
Completed NCT03418727 - Dry Eye Disease Study With Brimonidine Phase 2
Active, not recruiting NCT04425551 - Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction N/A
Recruiting NCT04527887 - Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED) Phase 4
Not yet recruiting NCT06379685 - Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface. Phase 1
Active, not recruiting NCT05618730 - Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B Phase 1
Completed NCT04553432 - Dry Eye OmniLenz Application of Omnigen Research Study Phase 4
Recruiting NCT04109170 - Dry Eye Evaluation System Based on Bioinformatics
Completed NCT04105842 - Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type N/A
Completed NCT05505292 - Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers Phase 4
Completed NCT04668131 - Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease N/A
Completed NCT06176651 - Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers Phase 4
Completed NCT02235259 - Efficacy and Safety of XG-104 for the Treatment of Dry Eye Phase 2
Not yet recruiting NCT02218827 - Topical Steroid Treatment For Dry Eye N/A
Completed NCT01959854 - Efficacy of Topical 0.2% Xanthan Gum in Patients With Dry Eye N/A