Trial reportPloS one2026
Comparative study on the clinical effectiveness of low-concentration cyclosporine eye drops in patients with dry eye disease.
Trial report in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05733624 (A Multicenter, Active Control, Parallel Group, Randomized, Double-blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of SCAI-001 Eye Drops in Patients With Dry Eye Disease), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Active Control, Parallel Group, Randomized, Double-blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of SCAI-001 Eye Drops in Patients With Dry Eye Disease
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis study aimed to evaluate the efficacy and safety of low-concentration, nanoparticle-based cyclosporine eye drops (SCAI-001 0.01% and SCAI-001 0.02%) compared to those of the conventional Restasis® (cyclosporine 0.05%) emulsion for dry eye disease (DED).
methodsIn this multicenter, randomized, double-blind, Phase 2 trial, patients with DED were assigned to three groups: SCAI-001 0.01%, SCAI-001 0.02%, and Restasis. The primary efficacy endpoint was the change in tear volume after 12 weeks. Secondary efficacy endpoints included changes in tear volume at 4 and 8 weeks, corneal and conjunctival surface staining scores, tear film breakup time (TBUT), standard patient evaluation of eye dryness questionnaire score (SPEED), and ocular surface disease index (OSDI) at 4, 8, and 12 weeks.
resultsTear volume increased in all groups at 12 weeks without intergroup differences. SCAI-001 0.01% and SCAI-001 0.02% achieved earlier improvements in tear volume at 4 weeks than that of Restasis, although no significant between-group difference was observed at any time point. Conjunctival surface scores improved in all groups at 4, 8, and 12 weeks, excluding 4 weeks of Restasis. Conjunctival staining improved to a greater extent 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 at 4, 8, and 12 weeks without intergroup differences.
conclusionsLow-concentration cyclosporine (SCAI-001 0.01% and SCAI-001 0.02%) demonstrated efficacy and safety comparable to that of Restasis in improving DED measures.
trial registrationClinicalTrials.gov Identifier: NCT05733624.
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