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Confirmatory Study of OPC-12759 Ophthalmic Solution

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
OPC-12759
Placebo
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

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 dry eye
  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

  • Kansai Region
  • Kanto region
  • Kyushu region
  • Tokai region

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

OPC-12759 ophthalmic solution

Placebo

OPC-12759 ophthalmic suspension

Arm Description

OPC-12759 ophthalmic solution

OPC-12759 ophthalmic solution 0%

OPC-12759 ophthalmic suspension

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. Changes of the FCS score from baseline to the last dose (last observation carried forward [LOCF]) were compared between 2% OPC-12759 ophthalmic solution and placebo by the t-test.

Secondary Outcome Measures

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 score from 0 to 3, and the total score was calculated (0-18). 0 is better. The scores and change from baseline at each examination (including LOCF) were compared between 2% OPC-12759 ophthalmic solution and placebo ophthalmic solution.

Full Information

First Posted
August 6, 2012
Last Updated
April 12, 2021
Sponsor
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01660256
Brief Title
Confirmatory Study of OPC-12759 Ophthalmic Solution
Official Title
Confirmatory Study of OPC-12759 Ophthalmic Solution in Patients With Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
May 2013 (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 solution is effective compared with placebo in dry eye patients. OPC-12759 ophthalmic suspension will be used as a reference drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPC-12759 ophthalmic solution
Arm Type
Experimental
Arm Description
OPC-12759 ophthalmic solution
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
OPC-12759 ophthalmic solution 0%
Arm Title
OPC-12759 ophthalmic suspension
Arm Type
Active Comparator
Arm Description
OPC-12759 ophthalmic suspension
Intervention Type
Drug
Intervention Name(s)
OPC-12759
Other Intervention Name(s)
rebamipide
Intervention Description
Instillation, 4 times/day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
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. Changes of the FCS score from baseline to the last dose (last observation carried forward [LOCF]) were compared between 2% OPC-12759 ophthalmic solution and placebo by the t-test.
Time Frame
Baseline, Week 4
Secondary Outcome Measure Information:
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 score from 0 to 3, and the total score was calculated (0-18). 0 is better. The scores and change from baseline at each examination (including LOCF) were compared between 2% OPC-12759 ophthalmic solution and placebo ophthalmic solution.
Time Frame
Baseline, Week 4

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 dry eye 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
Director of Division Dermatilogicals and Ophtalmolgicals, Otsuka Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Kansai Region
City
Kansai Region
Country
Japan
Facility Name
Kanto region
City
Kanto Region
Country
Japan
Facility Name
Kyushu region
City
Kyushu Region
Country
Japan
Facility Name
Tokai region
City
Tokai Region
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Confirmatory Study of OPC-12759 Ophthalmic Solution

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