Ciro Caruso1, Luigi Pacente2, Pasquale Troiano3, Carmine Ostacolo4, Luca D'Andrea5, Silvia Bartollino6, Ciro Costagliola6. 1. Corneal Transplant Center, Pellegrini Hospital, Via Portamedina alla Pignasecca 41, 80135, Naples, Italy. cirocarusoeye@gmail.com. 2. Corneal Transplant Center, Pellegrini Hospital, Via Portamedina alla Pignasecca 41, 80135, Naples, Italy. 3. Eye Clinic Fatebenefratelli Hospital, Via Fatebenefratelli n. 20, 22036, Como, Italy. 4. Department of Pharmaceutical Chemistry, University of Naples Federico II, Naples, Italy. 5. Eye Clinic, University of Naples Federico II, Via Sergio Pansini, 5, 80131, Naples, Italy. 6. Department of Medicine and Health Sciences "V. Tiberio", Università Del Molise, Via Cesare Gazzani, 86100, Campobasso, Italy.
Abstract
PURPOSE: To assess the ocular hypotensive effect of 15-keto fluprostenol, the oxidized metabolite of travoprost, on glaucoma patients, through a randomized double-masked placebo-controlled study. METHODS:Twelve patients with ocular normal tension glaucoma (NTG) (intraocular pressure [IOP] < 22 mmHg) were enrolled. In order to ensure patient compliance to treatment, all study subjects were hospitalized. In each patient, the eye to be submitted to the treatments was randomly chosen. After hospital admission (day 1), those patients received for 5 days at 8 P.M. either one drop of 15-keto fluprostenol (35 μg/ml) or one drop of placebo. IOP evaluation was performed within 8 A.M. and 8 P.M. for 6 days. Furthermore, we performed a determination of cardiovascular parameters before and after the treatments. RESULTS: Starting with the first IOP measurement after the first treatment (8 A.M. on day 2), IOP was reduced of about 14% in the eyes treated 15-keto fluprostenol, in comparison with baseline IOP values of 15-keto fluprostenol-treated patients. The IOP reduction in the 15-keto fluprostenol-treated group was significantly compared to placebo group (p < 0.05) starting from day 3 till day 6 of the study. Except for mild hyperemia in one 15-keto fluprostenol-treated eye, no other side effects were observed or reported by the enrolled patients. CONCLUSIONS: The travoprost metabolite 15-keto fluprostenol was effective in decrease IOP and maintained IOP reduction along 5 days of treatment. The 15-keto fluprostenol can be developed as a good candidate for once-a-day NTG patients' treatment.
RCT Entities:
PURPOSE: To assess the ocular hypotensive effect of 15-keto fluprostenol, the oxidized metabolite of travoprost, on glaucomapatients, through a randomized double-masked placebo-controlled study. METHODS: Twelve patients with ocular normal tension glaucoma (NTG) (intraocular pressure [IOP] < 22 mmHg) were enrolled. In order to ensure patient compliance to treatment, all study subjects were hospitalized. In each patient, the eye to be submitted to the treatments was randomly chosen. After hospital admission (day 1), those patients received for 5 days at 8 P.M. either one drop of 15-keto fluprostenol (35 μg/ml) or one drop of placebo. IOP evaluation was performed within 8 A.M. and 8 P.M. for 6 days. Furthermore, we performed a determination of cardiovascular parameters before and after the treatments. RESULTS: Starting with the first IOP measurement after the first treatment (8 A.M. on day 2), IOP was reduced of about 14% in the eyes treated 15-keto fluprostenol, in comparison with baseline IOP values of 15-keto fluprostenol-treated patients. The IOP reduction in the 15-keto fluprostenol-treated group was significantly compared to placebo group (p < 0.05) starting from day 3 till day 6 of the study. Except for mild hyperemia in one 15-keto fluprostenol-treated eye, no other side effects were observed or reported by the enrolled patients. CONCLUSIONS: The travoprost metabolite 15-keto fluprostenol was effective in decrease IOP and maintained IOP reduction along 5 days of treatment. The 15-keto fluprostenol can be developed as a good candidate for once-a-day NTG patients' treatment.
Entities:
Keywords:
15-keto fluprostenol; Glaucoma; IOP; NTG; Normal tension glaucoma
Authors: Robert N Weinreb; Tuyen Ong; Baldo Scassellati Sforzolini; Jason L Vittitow; Kuldev Singh; Paul L Kaufman Journal: Br J Ophthalmol Date: 2014-12-08 Impact factor: 4.638