Back to resultsLong Term Administration Study of OPC-12759 Ophthalmic Suspension
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
OPC-12759 Ophthalmic suspension
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes
Eligibility Criteria
Inclusion Criteria:
- Out patient;
- Ocular discomfort severity is moderate to severe;
- Corneal-conjunctival damage is moderate to severe;
- Unanesthetized Schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5 seconds 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 scicca;
- Ocular hypertention patient or glaucoma patient with ophthalmic solution;
- Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study;
- Anticipated use of contact lens during the study;
- Patient with punctal plug;
- 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 procedual medications;
- Receipt of any investigational product within 4 months.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OPC-12759 Ophthalmic suspension
Arm Description
Instillation, 4times/day
Outcomes
Primary Outcome Measures
Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score
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. Baseline scores and those obtained at each examination time point were compared (paired t-test).
Secondary Outcome Measures
Full Information
NCT ID
NCT00818324
First Posted
January 4, 2009
Last Updated
January 7, 2014
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00818324
Brief Title
Long Term Administration Study of OPC-12759 Ophthalmic Suspension
Official Title
Long Term Administration Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
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 safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks 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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OPC-12759 Ophthalmic suspension
Arm Type
Experimental
Arm Description
Instillation, 4times/day
Intervention Type
Drug
Intervention Name(s)
OPC-12759 Ophthalmic suspension
Intervention Description
Instillation,4times/day,for 52weeks
Primary Outcome Measure Information:
Title
Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score
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. Baseline scores and those obtained at each examination time point were compared (paired t-test).
Time Frame
Baseline, Week2, Week4, Week28, Week52
Other Pre-specified Outcome Measures:
Title
Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score
Description
LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-18). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test).
Time Frame
Baseline, Week2, Week4, Week28, Week52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Out patient;
Ocular discomfort severity is moderate to severe;
Corneal-conjunctival damage is moderate to severe;
Unanesthetized Schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5 seconds 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 scicca;
Ocular hypertention patient or glaucoma patient with ophthalmic solution;
Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study;
Anticipated use of contact lens during the study;
Patient with punctal plug;
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 procedual medications;
Receipt of any investigational product within 4 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eiji Murakami
Organizational Affiliation
OPCJ-DDO
Official's Role
Study Chair
Facility Information:
City
Kansai region
Country
Japan
City
Kanto region
Country
Japan
City
Kyushu region
Country
Japan
City
Tohoku region
Country
Japan
City
Tokai region
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Long Term Administration Study of OPC-12759 Ophthalmic Suspension
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