- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00234078
Dose-response Study of OPC-12759 Ophthalmic Suspension
January 20, 2014 updated by: Otsuka Pharmaceutical Co., Ltd.
The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic suspension in dry eye patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
290
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tokyo, Japan
- Otsuka Pharmaceutical Co., Ltd.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Outpatient.
- Subjective complaint of dry eye that has been present for minimum 20 months.
- Primary ocular discomfort severity is moderate to severe.
- Corneal - conjunctival damage is moderate to severe.
- Unanesthetized Schirmer's test score of 7mm/5minutes or less.
- Best corrected visual acuity of 0.2 or better in both eyes.
Exclusion Criteria:
- Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca.
- Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study.
- Anticipated use of contact lens during the study.
- Any history of ocular surgery within 12 months.
- Female patients who are pregnant, possibly pregnant or breast feeding;
- Known hypersensitivity to any component of the study drug or procedural medications.
- Receipt of any investigational product within 4 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 0.5% OPC-12759
0.5% OPC-12759 (rebamipide) ophthalmic suspension
|
|
Experimental: 1% OPC-12759
1% OPC-12759 (rebamipide) ophthalmic suspension
|
|
Experimental: 2% OPC-12759
2% OPC-12759 (rebamipide) ophthalmic suspension
|
|
Placebo Comparator: placebo
placebo of OPC-12759 (rebamipide) ophthalmic suspension
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)
Time Frame: baseline, 12 weeks
|
FCS indicates the damage to the corneal epithelium.
Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15).
0 is better.
The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response.
A general linear model was used to examine if slope parameters were not equal to zero.
|
baseline, 12 weeks
|
Change in Primary Ocular Discomfort (POD) Score From Baseline to Last Observation Carried Forward (LOCF)
Time Frame: Baseline, 12 weeks
|
POD indicates the ocular symptom most bothersome to the patient.
POD selected by each patient from among the following ocular symptoms; Foreign body sensation, Dryness, Photophobia, Eye pain and Blurred vision.
POD was scored from 0 through 4; a score of 0 indicated no symptoms and a score of 4 indicated very severe symptoms.
0 is better.
The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response.
A general linear model was used to examine if slope parameters were not equal to zero.
|
Baseline, 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Satoshi Oshima, Dermatologicals & Ophthalmologicals Division
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
April 1, 2006
Study Completion (Actual)
March 1, 2007
Study Registration Dates
First Submitted
October 4, 2005
First Submitted That Met QC Criteria
October 4, 2005
First Posted (Estimate)
October 6, 2005
Study Record Updates
Last Update Posted (Estimate)
February 28, 2014
Last Update Submitted That Met QC Criteria
January 20, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Lacrimal Apparatus Diseases
- Keratoconjunctivitis
- Conjunctivitis
- Conjunctival Diseases
- Keratitis
- Corneal Diseases
- Dry Eye Syndromes
- Keratoconjunctivitis Sicca
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Protective Agents
- Anti-Ulcer Agents
- Antioxidants
- Rebamipide
Other Study ID Numbers
- 037E-04-002
- JapicCTI-050040
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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