Comparative study on the clinical effectiveness of low-concentration cyclosporine eye drops in patients with dry eye disease.
PLoS OneSep 28, 2026 (epub)
Clinical ResearchOphthalmology
Jae Hyun Kim, Hui Kyung Kim, Young-Joo Shin et al.
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In 30 seconds
This multicenter, randomized, double-blind Phase 2 trial evaluated the efficacy and safety of low-concentration cyclosporine eye drops (SCAI-001 0.01% and 0.02%) versus Restasis (0.05%) in patients with dry eye disease. At 12 weeks, tear volume increased in all groups without significant intergroup differences, although SCAI-001 showed earlier improvements at 4 weeks.
Key findings
- Tear volume increased in all groups at 12 weeks without intergroup differences.
- SCAI-001 0.01% and 0.02% showed earlier improvements in tear volume at 4 weeks compared to Restasis.
- Conjunctival staining improved more with SCAI-001 0.01% than with Restasis at weeks 4 and 8.
- Corneal surface scores, TBUT, SPEED, and OSDI scores improved in all groups without intergroup differences.
Why it matters
The findings suggest that low-concentration cyclosporine eye drops may provide a comparable alternative to Restasis for managing dry eye disease, potentially offering earlier symptom relief.