Trial reportMedicine2019
Efficacy and safety of 0.05% cyclosporine ophthalmic emulsion in treatment of Chinese patients with moderate to severe dry eye disease: A 12-week, multicenter, randomized, double-masked, placebo-controlled phase III clinical study.
Trial report in Medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06392438 (Combination of 0.09% Cyclosporine and Intense Pulsed Light), which is not on this map. Cited by 13 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Combination of 0.09% Cyclosporine and Intense Pulsed Light (IPL) Therapy for the Treatment of Dry Eye Disease in Symptomatic Contact Lens Wearers: a Sham-Controlled Randomized Clinical Trial
Who cites it
13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 26 citations in OpenAlex.
- Evidence on the Use of Topical Ciclosporin for Ocular Surface Disease: A Systematic Review and Meta-Analysis.Clinical & experimental ophthalmology · 2025Pooled it
- Comparison of seven cyclosporine A formulations for dry eye disease: A systematic review and network meta-analysis.Frontiers in pharmacology · 2022Pooled it
- Corneal lymphangiogenesis as a potential target in dry eye disease - a systematic review.Survey of ophthalmologyPooled it
- Effectiveness of cyclosporine nanoemulsion eye drops in patients with mild-to-moderate dry eyes: objective and subjective evaluation.BMC ophthalmology · 2024Trial
- Article
- Comparative study of the therapeutic effects of different medications on DM-associated dry eye syndrome after vitrectomy.Frontiers in medicine · 2026Article
- Assessment the Safety of CyclASol compared with Vehicle and Commercially Available 0.05% Cyclosporine in Dry Eye Disease: A Systematic Review and Meta-analysis.Ophthalmology and therapy · 2025Article
- Cyclosporine a in the treatment of dry eye disease: a narrative review.Frontiers in ophthalmology · 2025Review
- A real-world disproportionality analysis of cyclosporine from the FDA Adverse Event Reporting System (FAERS) database.Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica · 2024Article
- Management of inflammation in dry eye disease: Recommendations from a European panel of experts.European journal of ophthalmology · 2023Review
- Effectiveness of Topical Cyclosporin-A 0.1% Compared to Combined Topical Cyclosporin-A 0.1% with Topical Sodium Hyaluronate on Interleukin-6 Levels in the Tears of Patients with Dry Eye Disease.Vision (Basel, Switzerland) · 2023Article
- Personalized Management of Dry Eye Disease: Beyond Artificial Tears.Clinical ophthalmology (Auckland, N.Z.) · 2022Review
- Topical Therapeutic Options in Corneal Neuropathic Pain.Frontiers in pharmacology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDry eye disease (DED) is a chronic ocular surface disease that affects hundreds of millions of people worldwide. Although 0.05% cyclosporine ophthalmic emulsion (CsA OE) has long been prescribed in the U.S. for the treatment of DED, it is not commercially available in China. Our study aims to compare the efficacy and safety profile of 0.05% CsA OE versus vehicle in Chinese patients with moderate to severe DED.
methodsThis was a multicenter, randomized, double-masked, 2-parallel-arm, 3-month phase III study. Patients with moderate to severe DED were randomized to receive twice-daily 0.05% CsA OE or its vehicle, along with unpreserved hypromellose eye drops 3 times per day. Patients were followed up at day 7, 28, 56, and 84, as well as 2 weeks after the medications were discontinued for safety assessment.
resultsA total of 240 patients were randomized. The overall effective rate (OER) and efficacy index were significantly better in the CsA OE than vehicle group at all follow up times (all P < .05), and the OER of CsA OE and vehicle group at month 3 was 70.6% and 27.8%, respectively (P < .001) (primary endpoint). The patients in CsA OE group displayed a significant improvement in dry eye symptoms from day 28 and ocular surface test results from day 7 (all P < .05). The ocular surface disease index scores of 0.05% CsA OE treated patients were significantly better than those treated with vehicle control at day 56 and 84 (P = .0061 and <.001, respectively). Drug related adverse events (AEs) were recorded in 6(5%) and 3(2.5%) patients in the CsA OE and vehicle groups respectively (P = .4061) with ocular pain as the most frequently reported AEs, and it was mostly mild to moderate. There were no detrimental effects on visual acuity, intraocular pressure, or vital signs.
conclusionsTwice-daily instillation of 0.05% CsA OE was effective and well tolerated for the treatment of moderate to severe DED in Chinese population during the 3 months of the study.
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