Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01027013
Other study ID # ACU-RED-203
Secondary ID
Status Completed
Phase Phase 2
First received December 4, 2009
Last updated January 9, 2012
Start date December 2009
Est. completion date November 2010

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 rebamipide 2% suspension for the treatment of patients with dry-eye.


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date November 2010
Est. primary completion date October 2010
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

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


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 Central Maine Eye Care Lewiston Maine
United States Richard Eiferman, MD Louisville Kentucky
United States Total Eye Care, P.A. Memphis Tennessee
United States The Eye Care Group, P.C. Waterbury Connecticut

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 Total fluorescein corneal staining score 4 weeks No
Primary Primary ocular discomfort 4 weeks No
Secondary Dry eye symptoms 12 weeks No
Secondary Ocular staining 12 weeks No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04425551 - Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction N/A
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
Recruiting NCT04701086 - 3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis N/A
Active, not recruiting NCT03697876 - Safety and Tolerability of the Ophthalmic Gel PRO-165 Versus Artelac® Nightime Gel Phase 1
Terminated NCT02815293 - Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye Phase 3
Completed NCT02910713 - Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation N/A
Completed NCT04104997 - A Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of GLH8NDE After Single and Mutiple Ocular Administrations in Healthy Korean and Caucasian Volunteers Phase 1
Recruiting NCT02595606 - 0.3% Sodium Hyaluronate in the Treatment of Dry Eye of Diabetic Patients Phase 4
Completed NCT01711424 - An Observational Study of OPTIVE PLUS® for the Treatment of Dry Eye Disease N/A
Completed NCT01202747 - Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction Phase 2/Phase 3
Completed NCT01015209 - Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers Phase 1
Completed NCT00969280 - Acupuncture for Dry Eye Syndrome Phase 3
Completed NCT01496482 - Comparison of Evaporimetry With the Established Methods of Tear Film Measurement N/A
Completed NCT00739713 - Effects of Sea Buckthorn Oil on Dry Eye N/A
Completed NCT00756678 - Efficacy and Acceptability of Two Lubricant Eye Drops Phase 4
Completed NCT00370747 - Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome Phase 2
Completed NCT00349440 - Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy Phase 4
Completed NCT05162261 - to Evaluate the Effectiveness and Safety of the Tixel® , VS LipiFlow® in the Treatment of Meibomian Gland Dysfunction N/A
Completed NCT02871440 - A Two Comparator, Controlled Phase 3 Study in Patients With and Without Evaporative Dry Eye Phase 3
Completed NCT05042960 - Computer Screen Properties Study N/A