Clinical trial of tear exchangeable limbal supported rigid contact lens CS-100 for ocular sequelae due to Stevens-Johnson syndrome
Phase 1
- Conditions
- Patients with ocular sequelae due to Stevens-Johnson syndrome(SJS)
- Registration Number
- JPRN-UMIN000014148
- Lead Sponsor
- Kyoto Prefectural University of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Patients who are beleived to be inappropriate due to complications below; - An acute or sub-acute inflammation of anterior eye part - An active corneal infection - An uveitis (2) Patients who are hypersensitive to fit CL (3) Patients who are believed to be exposed to dust and chemical drug with eyes (4) Patients who are believed to have trouble with fit CL (5) Patients performed ocular operations (such as cataract surgery, surgery of glaucoma treatment, corneal transplantation and so on) within latest 3 months (6) Patients for whom it has been determined by the medical doctors that there will be complicating issues with the patient participating in the clinical trial for other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main outcome measure is over LogMAR 0.2 improvement rate of bestcorrected visual acuity(BCVA) at before CL fitting and at after 3 months use of the limbal-supported CL post fitting
- Secondary Outcome Measures
Name Time Method (1) Change value of bestcorrected visual acuity(BCVA) at before CL fitting and at after 3 months use of the limbal-supported CL post fitting (2) Change value of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) composite score (3) Change severity of pain and dryness in the eye (VAS scale) (4) Incidence rates and severities of adverse events