The Effect of OTX-101 on Tear Production in Patients with Severe Tear-deficient Dry Eye Disease: A Pooled Analysis of Phase 2b/3 and Phase 3 Studies
| Autor: | Paul M. Karpecki, Brittany Mitchell, Preeya K. Gupta, Melissa Toyos |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
business.industry Keratoconjunctivitis Sicca Disease eye diseases Sensory Systems Tear production Cellular and Molecular Neuroscience Ophthalmology Clinical Trials Phase II as Topic Pooled analysis Clinical Trials Phase III as Topic Tears Cyclosporine Humans Medicine KERATOCONJUNCTIVITIS SICCA Dry Eye Syndromes In patient sense organs Ophthalmic Solutions business Randomized Controlled Trials as Topic |
| Zdroj: | Current Eye Research. 47:220-224 |
| ISSN: | 1460-2202 0271-3683 |
| DOI: | 10.1080/02713683.2021.1966477 |
| Popis: | Impaired tear production - a common sign of keratoconjunctivitis sicca (KCS) - is associated with qualitative or quantitative tear deficiency. OTX-101 0.09% is a novel, nanomicellar formulation of cyclosporine A approved in the US for increasing tear production in patients with KCS. We present a pooled analysis of the phase 2b/3 and phase 3 studies evaluating the effect of OTX-101 on tear production in a subgroup of patients with keratoconjunctivitis sicca with severely impaired tear production (Schirmer's score5 mm in either eye at baseline).In these randomized, double-masked studies, patients instilled 1 drop OTX-101 or vehicle per eye twice daily for 84 days. Pooled efficacy endpoints included percent (%) of patients with ≥10 mm change from baseline and mean change from baseline in Schirmer's score at day 84. Pooled safety endpoints included adverse event monitoring.Subgroup analyses included 133 and 113 patients receiving OTX-101 and vehicle, respectively. Mean baseline (BL) Schirmer's score ± standard deviation was 2.7 ± 1.2 for OTX-101 and 2.5 ± 1.1 mm for vehicle (OTX-101 administered twice daily for 84 days significantly improved tear production vs vehicle in patients with severely impaired tear production, as evidenced by significantly larger proportion of patients with ≥10 mm increases from baseline and higher mean change from baseline in Schirmer's scores. |
| Databáze: | OpenAIRE |
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