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Intraocular pressure reduction with once-a-day application of a new prostaglandin eye drop: a pilot placebo-controlled study in 12 patients

  • Ciro CarusoEmail author
  • Luigi Pacente
  • Pasquale Troiano
  • Carmine Ostacolo
  • Luca D’Andrea
  • Silvia Bartollino
  • Ciro Costagliola
Original Paper
  • 14 Downloads

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.

Keywords

NTG Normal tension glaucoma 15-keto fluprostenol IOP Glaucoma 

Notes

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

Human and animal rights

This article does not contain any studies with animals performed by any of the authors.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Copyright information

© Springer Nature B.V. 2019

Authors and Affiliations

  1. 1.Corneal Transplant CenterPellegrini HospitalNaplesItaly
  2. 2.Eye ClinicUniversity of Naples Federico IINaplesItaly
  3. 3.Department of Pharmaceutical ChemistryUniversity of Naples Federico IINaplesItaly
  4. 4.Eye Clinic Fatebenefratelli HospitalComoItaly
  5. 5.Department of Medicine and Health Sciences “V. Tiberio”Università Del MoliseCampobassoItaly

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