Phase Ⅰ/Ⅱ, Double-Masked, Randomized, Vehicle-Controlled Study of H-1337 Ophthalmic Solution for Glaucoma and Ocular Hypertension
| Autor: | Paul J. Hartman, David L. Cooke, Henry H. Hsu, Jeanette Stewart, Kengo Sumi, Yoko Yoshida, Hiroyoshi Hidaka, Gary D. Novack |
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| Rok vydání: | 2023 |
| Předmět: |
Aging
Clinical Trials and Supportive Activities Neurosciences Evaluation of treatments and therapeutic interventions Glaucoma General Medicine Neurodegenerative Eye Open-Angle Clinical Research 6.1 Pharmaceuticals Humans Ocular Hypertension Ophthalmic Solutions Eye Disease and Disorders of Vision Intraocular Pressure |
| Zdroj: | Ophthalmology. Glaucoma, vol 6, iss 2 |
| ISSN: | 2589-4196 |
| Popis: | PurposeTo perform a phase Ⅰ/Ⅱ evaluation of an H-1337 ophthalmic solution in subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).DesignThis was a phase I/II, randomized, double-masked, vehicle-controlled, dose-response study conducted at 6 private practice sites in the United States. The study was registered with clinicaltrials.gov as NCT03452033.ParticipantsEighty-seven subjects with bilateral POAG or OHT were enrolled.MethodsAfter washout of ocular hypotensive medications as required, the subjects were randomized to receive either the H-1337 ophthalmic solution at 0.06%, 0.2%, and 0.6% or its vehicle twice daily unilaterally in the study eye for the first 3 days and then twice daily in both eyes from day 4 to28.Main outcome measuresThe primary efficacy end point was the mean change in intraocular pressure from baseline (day 0) for each group on day 28 at hour 4 compared with the vehicle.ResultsIn the primary efficacy end point, i.e., mean change from the baseline on day 28 at hour 4, the mean change from the baseline was- 4.45 ± 3.801,- 5.16 ± 3.114,- 4.93 ± 3.110, and- 0.39 ± 2.355 in the 0.06%, 0.2%, and 0.6% H-1337 and vehicle groups, respectively. The difference between each active group and the vehicle group was statistically significant (P < 0.0001). Treatment-emergent adverse events (TEAEs) occurred in 49% of subjects who received H-1337 (range, 41% [0.2% arm]-64% [0.6% arm] across the H-1337 arms) and 18% of subjects who received the vehicle. The majority of TEAEs were mild in severity; 3 subjects who received H-1337 had a TEAE of moderate intensity (instillation site erythema, blurred vision, and muscle strain).ConclusionsThe H-1337 ophthalmic solution showed clinically and statistically significant ocular hypotensive activity and was well tolerated, with a relatively low incidence of hyperemia.Financial disclosure(s)Proprietary or commercial disclosure may be found after the references. |
| Databáze: | OpenAIRE |
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