Confirmatory study of OPC-12759 Ophthalmic Solutio
- Conditions
- Dry Eye
- Registration Number
- JPRN-jRCT2080221875
- Lead Sponsor
- Otsuka Pharmaceuticals Co., Ltd.
- Brief Summary
In conclusion, 2% OPC-12759 ophthalmic solution is effective for the treatment of dry eye and shows comparable efficacy to that of 2% OPC-12759 ophthalmic suspension. There were no significant safety concerns with regard to 2% OPC-12759 ophthalmic solution in the present study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 209
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
1. Presence of anterior segment disease or disorder other than that associated with dry eye
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
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Fluorescein corneal staining scores
- Secondary Outcome Measures
Name Time Method efficacy<br>Lissamine green conjunctival staining scores