NCT00885079

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
188

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

5 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

First Submitted

Initial submission to the registry

April 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2009

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

December 12, 2013

Completed
Last Updated

December 12, 2013

Status Verified

November 1, 2013

Enrollment Period

10 months

First QC Date

April 19, 2009

Results QC Date

September 12, 2013

Last Update Submit

November 18, 2013

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (2)

  • 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

    Baseline, Weeks4

  • 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.

    Baseline, Weeks4

Study Arms (2)

Rebamipide

EXPERIMENTAL

Instillation,4 times/day for 4 weeks

Drug: OPC-12759 Ophthalmic suspension

Hyaluronate

ACTIVE COMPARATOR

Instillation,6 times/day for 4 weeks

Drug: Hyalein Mini Ophthalmic solution

Interventions

OPC-12759 Ophthalmic suspensionDRUG

OPC-12759 Ophthalmic suspension 2%

Rebamipide
Hyalein Mini Ophthalmic solutionDRUG

Hyalein Mini Ophthalmic solution 0.1%

Hyaluronate

Eligibility Criteria

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

You may qualify if:

  • 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

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 (5)

Kyushu region

Kagoshima, Japan

Location

Chushikoku region

Matsuyama, Japan

Location

Tokai region

Nagoya, Japan

Location

Kansai region

Osaka, Japan

Location

Kanto region

Tokyo, Japan

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
Mr. Kyoji Imaoka
Organization
Otsuka Pharmaceutical Co., Ltd.
-81-6-6943-7722

Study Officials

  • Eiji Murakami

    OPCJ-DDO

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
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

April 19, 2009

First Posted

April 21, 2009

Study Start

May 1, 2009

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

December 12, 2013

Results First Posted

December 12, 2013

Record last verified: 2013-11

Locations

JP(5)