NCT00475319

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
308

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

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

May 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 21, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
5 years until next milestone

Results Posted

Study results publicly available

June 5, 2013

Completed
Last Updated

June 13, 2013

Status Verified

May 1, 2013

Enrollment Period

10 months

First QC Date

May 16, 2007

Results QC Date

January 31, 2013

Last Update Submit

June 4, 2013

Conditions

Dry Eye Syndromes

Keywords

Dry Eye SyndromesOPC-12759

Outcome Measures

Primary Outcomes (1)

  • 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, 4weeks

Secondary Outcomes (1)

  • Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF)

    Baseline, 4weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

0% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.

Drug: placebo

1% OPC-12759 ophthalmic suspension

EXPERIMENTAL

1% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.

Drug: 1% OPC-12759 ophthalmic suspension

2% OPC-12759 ophthalmic suspension

EXPERIMENTAL

2% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.

Drug: 2% OPC-12759 ophthalmic suspension

Interventions

placeboDRUG

comparison of different dosages of drug

Placebo
1% OPC-12759 ophthalmic suspensionDRUG

comparison of different dosages of drug

1% OPC-12759 ophthalmic suspension
2% OPC-12759 ophthalmic suspensionDRUG

comparison of different dosages of drug

2% OPC-12759 ophthalmic suspension

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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Kansai Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Shikoku Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

Related Publications (1)

  • Kinoshita S, Awamura S, Oshiden K, Nakamichi N, Suzuki H, Yokoi N; Rebamipide Ophthalmic Suspension Phase II Study Group. Rebamipide (OPC-12759) in the treatment of dry eye: a randomized, double-masked, multicenter, placebo-controlled phase II study. Ophthalmology. 2012 Dec;119(12):2471-8. doi: 10.1016/j.ophtha.2012.06.052. Epub 2012 Sep 23.

    PMID: 23009892DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
Eiji Murakami
Organization
Dermatologicals & Ophthalmologicals, Otsuka Pharmaceutical Co., Ltd.
+81-6-6231-6067

Study Officials

  • Satoshi Oshima

    Division of dermatologicals and ophthalmologicals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2007

First Posted

May 21, 2007

Study Start

May 1, 2007

Primary Completion

March 1, 2008

Study Completion

June 1, 2008

Last Updated

June 13, 2013

Results First Posted

June 5, 2013

Record last verified: 2013-05

Locations

JP(6)