ong Term Administration Study of OPC-12759 Ophthalmic Suspensio
- Conditions
- Dry eye syndromes
- Registration Number
- JPRN-jRCT2080220651
- Lead Sponsor
- Otsuka Pharmaceuticals Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 153
1.Out patient;
2.Ocular discomfort severity is moderate to severe;
3.Cornaeal-conjunctival damage is moderate to severe;
4.Unanaesthetized Schirmer's test score of 5mm/5 minutes or less, or tear breakup time is 5 seconds or less;
5.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 keratoconjunctivitis scicca;
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 procedual 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
- Secondary Outcome Measures
Name Time Method