Dose-response Study of OPC-12759 Ophthalmic Suspension

Phase 2

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: 0.5% OPC-12759; Drug: 1% OPC-12759; Drug: 2% OPC-12759; Drug: placebo

• Registration Number: NCT00234078
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-04
• Study First Posted: 2005-10-06
• Primary Completion: 2006-04
• Study Completion: 2007-03
• Status Verified: 2014-01
• Results First Submitted: 2014-01-20
• Results First Submitted QC: 2014-01-20
• Last Update Submitted: 2014-01-20
• Results First Posted: 2014-02-28
• Last Update Posted: 2014-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

1. Outpatient.
2. Subjective complaint of dry eye that has been present for minimum 20 months.
3. Primary ocular discomfort severity is moderate to severe.
4. Corneal - conjunctival damage is moderate to severe.
5. Unanesthetized Schirmer's test score of 7mm/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. Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study.
3. Anticipated use of contact lens during the study.
4. Any history of ocular surgery within 12 months.
5. Female patients who are pregnant, possibly pregnant or breast feeding;
6. Known hypersensitivity to any component of the study drug or procedural medications.
7. Receipt of any investigational product within 4 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.5% OPC-12759	0.5% OPC-12759	0.5% OPC-12759 (rebamipide) ophthalmic suspension
1% OPC-12759	1% OPC-12759	1% OPC-12759 (rebamipide) ophthalmic suspension
2% OPC-12759	2% OPC-12759	2% OPC-12759 (rebamipide) ophthalmic suspension
placebo	placebo	placebo of OPC-12759 (rebamipide) ophthalmic suspension

Primary Outcome Measures

Name	Time	Method
Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)	baseline, 12 weeks	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.
Change in Primary Ocular Discomfort (POD) Score From Baseline to Last Observation Carried Forward (LOCF)	Baseline, 12 weeks	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.

Trial Locations

Locations (1)

Otsuka Pharmaceutical Co., Ltd.; 🇯🇵 Tokyo, Japan