Confirmatory Study of OPC-12759 Ophthalmic Suspension

Phase 3

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: Hyalein Mini Ophthalmic solution; Drug: OPC-12759 Ophthalmic suspension

• Registration Number: NCT00885079
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-19
• Study First Submitted QC: 2009-04-20
• Study First Posted: 2009-04-21
• Study Start: 2009-05
• Primary Completion: 2010-03
• Study Completion: 2010-04
• Results First Submitted: 2013-09-12
• Status Verified: 2013-11
• Results First Submitted QC: 2013-11-18
• Last Update Submitted: 2013-11-18
• Results First Posted: 2013-12-12
• Last Update Posted: 2013-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronate	Hyalein Mini Ophthalmic solution	Instillation,6 times/day for 4 weeks
Rebamipide	OPC-12759 Ophthalmic suspension	Instillation,4 times/day for 4 weeks

Primary Outcome Measures

Name	Time	Method
Change in Fluorescein Corneal Staining (FCS) Score From Baseline	Baseline, Weeks4	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	Baseline, Weeks4	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.

Trial Locations

Locations (5)

Kanto region; 🇯🇵 Tokyo, Japan

Kansai region; 🇯🇵 Osaka, Japan

Kyushu region; 🇯🇵 Kagoshima, Japan

Chushikoku region; 🇯🇵 Matsuyama, Japan

Tokai region; 🇯🇵 Nagoya, Japan