Back to resultsDose-response Study of OPC-12759 Ophthalmic Suspension
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
0.5% OPC-12759
1% OPC-12759
2% OPC-12759
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes focused on measuring OPC-12759, Dry eye syndromes
Eligibility Criteria
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.
Sites / Locations
- Otsuka Pharmaceutical Co., Ltd.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
0.5% OPC-12759
1% OPC-12759
2% OPC-12759
placebo
Arm Description
0.5% OPC-12759 (rebamipide) ophthalmic suspension
1% OPC-12759 (rebamipide) ophthalmic suspension
2% OPC-12759 (rebamipide) ophthalmic suspension
placebo of OPC-12759 (rebamipide) ophthalmic suspension
Outcomes
Primary Outcome Measures
Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)
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)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00234078
First Posted
October 4, 2005
Last Updated
January 20, 2014
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00234078
Brief Title
Dose-response Study of OPC-12759 Ophthalmic Suspension
Official Title
Dose-response Study of OPC-12759 Ophthalmic Suspension
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic suspension in dry eye patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
Keywords
OPC-12759, Dry eye syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
290 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.5% OPC-12759
Arm Type
Experimental
Arm Description
0.5% OPC-12759 (rebamipide) ophthalmic suspension
Arm Title
1% OPC-12759
Arm Type
Experimental
Arm Description
1% OPC-12759 (rebamipide) ophthalmic suspension
Arm Title
2% OPC-12759
Arm Type
Experimental
Arm Description
2% OPC-12759 (rebamipide) ophthalmic suspension
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo of OPC-12759 (rebamipide) ophthalmic suspension
Intervention Type
Drug
Intervention Name(s)
0.5% OPC-12759
Intervention Type
Drug
Intervention Name(s)
1% OPC-12759
Intervention Type
Drug
Intervention Name(s)
2% OPC-12759
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)
Description
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.
Time Frame
baseline, 12 weeks
Title
Change in Primary Ocular Discomfort (POD) Score From Baseline to Last Observation Carried Forward (LOCF)
Description
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.
Time Frame
Baseline, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satoshi Oshima
Organizational Affiliation
Dermatologicals & Ophthalmologicals Division
Official's Role
Study Director
Facility Information:
Facility Name
Otsuka Pharmaceutical Co., Ltd.
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Dose-response Study of OPC-12759 Ophthalmic Suspension
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