Long Term Administration Study of OPC-12759 Ophthalmic Suspension

Phase 3

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: OPC-12759 Ophthalmic suspension

• Registration Number: NCT00818324
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks in dry eye patients

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-04
• Study First Submitted QC: 2009-01-05
• Study First Posted: 2009-01-07
• Primary Completion: 2010-09
• Study Completion: 2011-01
• Status Verified: 2014-01
• Results First Submitted: 2014-01-07
• Results First Submitted QC: 2014-01-07
• Last Update Submitted: 2014-01-07
• Results First Posted: 2014-02-26
• Last Update Posted: 2014-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

1. Out patient;
2. Ocular discomfort severity is moderate to severe;
3. Corneal-conjunctival damage is moderate to severe;
4. Unanesthetized Schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5 seconds or less;
5. 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 scicca;
2. Ocular hypertention 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 procedual medications;
9. Receipt of any investigational product within 4 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OPC-12759 Ophthalmic suspension	OPC-12759 Ophthalmic suspension	Instillation, 4times/day

Primary Outcome Measures

Name	Time	Method
Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score	Baseline, Week2, Week4, Week28, Week52	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. Baseline scores and those obtained at each examination time point were compared (paired t-test).