NCT00234078

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
7 years until next milestone

Results Posted

Study results publicly available

February 28, 2014

Completed
Last Updated

February 28, 2014

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

October 4, 2005

Results QC Date

January 20, 2014

Last Update Submit

January 20, 2014

Conditions

Dry Eye Syndromes

Keywords

OPC-12759Dry eye syndromes

Outcome Measures

Primary Outcomes (2)

  • 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.

    baseline, 12 weeks

  • 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.

    Baseline, 12 weeks

Study Arms (4)

0.5% OPC-12759

EXPERIMENTAL

0.5% OPC-12759 (rebamipide) ophthalmic suspension

Drug: 0.5% OPC-12759

1% OPC-12759

EXPERIMENTAL

1% OPC-12759 (rebamipide) ophthalmic suspension

Drug: 1% OPC-12759

2% OPC-12759

EXPERIMENTAL

2% OPC-12759 (rebamipide) ophthalmic suspension

Drug: 2% OPC-12759

placebo

PLACEBO COMPARATOR

placebo of OPC-12759 (rebamipide) ophthalmic suspension

Drug: placebo

Interventions

0.5% OPC-12759DRUG
0.5% OPC-12759
1% OPC-12759DRUG
1% OPC-12759
2% OPC-12759DRUG
2% OPC-12759
placeboDRUG
placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Otsuka Pharmaceutical Co., Ltd.

Tokyo, Japan

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

rebamipide

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
Director of Clinical Research and Development
Organization
Otsuka Pharmaceutical Co., Ltd.
+81-3-6361-7366

Study Officials

  • Satoshi Oshima

    Dermatologicals & Ophthalmologicals Division

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2005

First Posted

October 6, 2005

Study Start

January 1, 2005

Primary Completion

April 1, 2006

Study Completion

March 1, 2007

Last Updated

February 28, 2014

Results First Posted

February 28, 2014

Record last verified: 2014-01

Locations

JP(1)