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Confirmatory 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
Hyalein Mini Ophthalmic solution
Sponsored by
Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Out patient
  2. Subjective complaint of dry eye that has been present for minimum 20 months
  3. Ocular discomfort severity is moderate to severe
  4. Corneal - conjunctival damage is moderate to severe
  5. Unanesthetized Schirmer's test score of 5mm/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. Ocular hypertension patient or glaucoma patient with ophthalmic solution
  3. Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study
  4. Anticipated use of contact lens during the study
  5. Patient with punctal plug
  6. Any history of ocular surgery within 12 months
  7. Female patients who are pregnant,possibly pregnant or breast feeding
  8. Known hypersensitivity to any component of the study drug or procedural medications
  9. Receipt of any investigational product within 4 months.

Sites / Locations

  • Kyushu region
  • Chushikoku region
  • Tokai region
  • Kansai region
  • Kanto region

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rebamipide

Hyaluronate

Arm Description

Instillation,4 times/day for 4 weeks

Instillation,6 times/day for 4 weeks

Outcomes

Primary Outcome Measures

Change in Fluorescein Corneal Staining (FCS) Score From Baseline
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. Noninferiority for change from baseline in the FCS score (LOCF) was determined by comparing the noninferiority margin (0.4) with the upper limit of the 95% confidence interval (CI) of the difference between the 2 treatment groups
Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline
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 sdore from 0 to 3, and the total score was calculated (0-18). 0 is better. Superiority was verified by comparing t-test results for change from baseline in the LGCS score (LOCF) between 2 treatment groups.

Secondary Outcome Measures

Full Information

First Posted
April 19, 2009
Last Updated
November 18, 2013
Sponsor
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00885079
Brief Title
Confirmatory Study of OPC-12759 Ophthalmic Suspension
Official Title
Confirmatory Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 2010 (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 verify whether OPC-12759 ophthalmic suspension is effective compared with active control 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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rebamipide
Arm Type
Experimental
Arm Description
Instillation,4 times/day for 4 weeks
Arm Title
Hyaluronate
Arm Type
Active Comparator
Arm Description
Instillation,6 times/day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
OPC-12759 Ophthalmic suspension
Intervention Description
OPC-12759 Ophthalmic suspension 2%
Intervention Type
Drug
Intervention Name(s)
Hyalein Mini Ophthalmic solution
Intervention Description
Hyalein Mini Ophthalmic solution 0.1%
Primary Outcome Measure Information:
Title
Change in Fluorescein Corneal Staining (FCS) Score From Baseline
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. Noninferiority for change from baseline in the FCS score (LOCF) was determined by comparing the noninferiority margin (0.4) with the upper limit of the 95% confidence interval (CI) of the difference between the 2 treatment groups
Time Frame
Baseline, Weeks4
Title
Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline
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 sdore from 0 to 3, and the total score was calculated (0-18). 0 is better. Superiority was verified by comparing t-test results for change from baseline in the LGCS score (LOCF) between 2 treatment groups.
Time Frame
Baseline, Weeks4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Out patient Subjective complaint of dry eye that has been present for minimum 20 months Ocular discomfort severity is moderate to severe Corneal - conjunctival damage is moderate to severe Unanesthetized Schirmer's test score of 5mm/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 Ocular hypertension 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 procedural 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:
Facility Name
Kyushu region
City
Kagoshima
Country
Japan
Facility Name
Chushikoku region
City
Matsuyama
Country
Japan
Facility Name
Tokai region
City
Nagoya
Country
Japan
Facility Name
Kansai region
City
Osaka
Country
Japan
Facility Name
Kanto region
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Confirmatory Study of OPC-12759 Ophthalmic Suspension

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