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Dose-response Study of OPC-12759 Ophthalmic Suspension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00234078
First received: October 4, 2005
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic suspension in dry eye patients.


Condition Intervention Phase
Dry Eye Syndromes
Drug: 0.5% OPC-12759
Drug: 1% OPC-12759
Drug: 2% OPC-12759
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose-response Study of OPC-12759 Ophthalmic Suspension

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF) [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in Primary Ocular Discomfort (POD) Score From Baseline to Last Observation Carried Forward (LOCF) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 290
Study Start Date: January 2005
Study Completion Date: March 2007
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.5% OPC-12759
0.5% OPC-12759 (rebamipide) ophthalmic suspension
Drug: 0.5% OPC-12759
Experimental: 1% OPC-12759
1% OPC-12759 (rebamipide) ophthalmic suspension
Drug: 1% OPC-12759
Experimental: 2% OPC-12759
2% OPC-12759 (rebamipide) ophthalmic suspension
Drug: 2% OPC-12759
Placebo Comparator: placebo
placebo of OPC-12759 (rebamipide) ophthalmic suspension
Drug: placebo

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Outpatient.
  2. Subjective complaint of dry eye that has been present for minimum 20 months.
  3. Primary ocular discomfort severity is moderate to severe.
  4. Corneal - conjunctival damage is moderate to severe.
  5. Unanesthetized Schirmer's test score of 7mm/5minutes or less.
  6. Best corrected visual acuity of 0.2 or better in both eyes.

Exclusion Criteria:

  1. Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca.
  2. Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study.
  3. Anticipated use of contact lens during the study.
  4. Any history of ocular surgery within 12 months.
  5. Female patients who are pregnant, possibly pregnant or breast feeding;
  6. Known hypersensitivity to any component of the study drug or procedural medications.
  7. Receipt of any investigational product within 4 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234078

Locations
Japan
Otsuka Pharmaceutical Co., Ltd.
Tokyo, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Satoshi Oshima Dermatologicals & Ophthalmologicals Division
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00234078     History of Changes
Other Study ID Numbers: 037E-04-002, JapicCTI-050040
Study First Received: October 4, 2005
Results First Received: January 20, 2014
Last Updated: January 20, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
OPC-12759
Dry eye syndromes

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Syndrome
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Disease
Eye Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Pathologic Processes
Rebamipide
Anti-Ulcer Agents
Antioxidants
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014