Long Term Administration Study of OPC-12759 Ophthalmic Suspension

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Rebamipide

Criteria

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.