Exploratory study of OPC-12759 Ophthalmic Suspensio
- Conditions
- Keratoconjunctival epithelial disorder
- Registration Number
- JPRN-jRCT2080221666
- Lead Sponsor
- Otsuka Pharmaceuticals Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 100
1. Diagnosis of superficial punctate keratopathy or corneal erosion
2. Fluorescein corneal staining score of 3 or higher
1. Active ocular infection
2. Vernal keratoconjunctivitis
3. Recurrent corneal erosion
4. Physical irritation of eyelashes or relaxed bulbar conjunctiva to cornea or conjunctiva
5. Subjects who cannot discontinue or anticipate use of eye drops except for limited concomitant ones during the study. Soft-santear is allowed during the screening period.
6. Anticipated use of contact lens during the study.
7. Insertion of punctal plug or fall out of punctal plug within 3 months
8. Subjects who are judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease.
9. Receipt of any investigational product within 4 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in keratoconjunctival staining scores
- Secondary Outcome Measures
Name Time Method