Trial reportGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2026
Effect of OTX-101 0.09% ciclosporin solution on clinical signs of dry eye disease in patients with moderate-to-severe corneal damage: a post-hoc analysis of randomized clinical trials.
Trial report in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis post-hoc analysis of two OTX-101 clinical trials assessed the efficacy of 0.09% ciclosporin in treating dry eye disease (DED) patients with moderate-to-severe corneal damage.
methodsThe criteria for moderate-to-severe corneal damage were defined as a CFS total score (5 zones) of ≥ 6 or single zone ≥ 2 at baseline (modified NEI scale). 516 patients (49% of the intention-to-treat population) met these criteria at baseline. Changes in ocular surface damage (cornea and conjunctiva) and aqueous tear deficiency from baseline were determined through corneal fluorescein staining (CSF), Lissamine green staining (LGS) and Schirmer's test without anesthesia (ST).
resultsAfter 12 weeks of treatment with OTX-101 versus (vs.) vehicle, outcomes improved across six parameters: (I) Central CFS mean change from baseline was -0.48 vs. -0.36, p = 0.0144. (II) Total CFS corneal staining change from baseline was -2.30 vs. -1.61 p = 0.0004. (III) Improvement ≥ 50% in total CFS from baseline was 44.8% vs. 33.4% p = 0. 0010. (IV) Conjunctival damage as measured by LGS mean change from baseline was -1.61 vs. -0.99, p = 0.0006. (V) Tear production as measured by ST as percentage of eyes with ≥ 10 mm increase from baseline was 18.2% vs. 8.3% p = 0.0003, and (VI) ST mean change from baseline was +2.94 vs. +0.28 p = 0.0008.
conclusionAdministration of OTX-101 0.09% leads to statistically significant improvement across six parameters in ocular surface staining and tear production in DED patients with moderate to severe corneal damage.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.