Clinical trial NCT01162603: Latanoprost Versus Tafluprost: 24-hour Intraocular Pressure (IOP)
Official title: Comparative Evaluation of Intraocular Pressure During the 24 Hour in Patients Affected by Primary Open-angle Glaucoma and Ocular Hypertension: Latanoprost 0.005% Versus Tafluprost 0.0015% Ophthalmic Solutions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Open Angle Glaucoma
Ocular Hypertension
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
Collaborators: name: Aristotle University Of Thessaloniki
First posted: 2010-07-14
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: * Main objective is to compare the ability of Latanoprost 0.005% preservative-added ophthalmic solution versus Tafluprost 0.0015% preservative-free ophthalmic solution, both given once a day at the evening, in reducing 24-hour intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. First efficacy variable will be the difference between mean nocturnal IOP values after three months of treatment: nocturnal IOP is defined as the mean value between 2AM and 6AM measurements.
* Secondary objectives will be the comparison between Latanoprost 0.005% and Tafluprost 0.0015% ophthalmic solution about:

  * Mean 24-hour IOP values after three months of treatment
  * IOP values at these time-points: 10AM (± 1 hour), 2PM (± 1 hour), 6PM (± 1 hour), 10PM (± 1 hour), 2AM (± 1 hour) and 6AM (± 1 hour) after three months of treatment


Eligibility criteria: Inclusion Criteria:

* Male and female patients \> 45 years
* Damage of the optic nerve and alterations of the visual field in case of POAG, no defects at the optic nerve and at the visual field in case of OHT
* Untreated IOP \> 24 mm Hg but \< 32 mm Hg in at least one eye at baseline (10AM) and central corneal thickness between 500 and 600 μm
* Negative pregnancy test (fertile women). Fertile women attending the study must express clear will to avoid pregnancy during all the study period and in the next three months
* Informed consent before starting the study

Exclusion Criteria:

* Secondary glaucoma (Sturge-Weber syndrome, Neurofibromatosis I, neovascular glaucoma, steroid glaucoma, etc)
* Anterior segment anomalies (cataract, irido-corneal disgenesy, congenital ectropion uvae, etc)
* Past ocular surgery, except cataract surgery in the previous 6 months
* Corneal abnormalities that can influence IOP measurements (corneal oedema)
* Positive pregnancy test or breast-feeding woman. No will to avoid pregnancy during all the study period and in the next three months

Primary outcomes:
measure: Intraocular Pressure
timeFrame: 24-hour
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Glaucoma Unit, 1st University Department of Ophthalmology, Aristotle University, AHEPA Hospital
city: Brescia
country: Italy
facility: USVD "Centro per lo studio del glaucoma" Spedali civili di Brescia
Study officials:
affiliation: Università degli Studi di Brescia
name: Luciano Quaranta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuwayama Y, Komemushi S; Tafluprost Multi-center Study Group. [Intraocular pressure lowering effect of 0.0015% tafluprost as compared to placebo in patients with normal tension glaucoma: randomized, double-blind, multicenter, phase III study]. Nippon Ganka Gakkai Zasshi. 2010 May;114(5):436-43. Japanese.
citation: Uusitalo H, Pillunat LE, Ropo A; Phase III Study Investigators. Efficacy and safety of tafluprost 0.0015% versus latanoprost 0.005% eye drops in open-angle glaucoma and ocular hypertension: 24-month results of a randomized, double-masked phase III study. Acta Ophthalmol. 2010 Feb;88(1):12-9. doi: 10.1111/j.1755-3768.2010.01862.x.
citation: Aihara M. Clinical appraisal of tafluprost in the reduction of elevated intraocular pressure (IOP) in open-angle glaucoma and ocular hypertension. Clin Ophthalmol. 2010 Mar 24;4:163-70. doi: 10.2147/opth.s6368.
citation: Hommer A, Mohammed Ramez O, Burchert M, Kimmich F. IOP-lowering efficacy and tolerability of preservative-free tafluprost 0.0015% among patients with ocular hypertension or glaucoma. Curr Med Res Opin. 2010 Aug;26(8):1905-13. doi: 10.1185/03007995.2010.492030.
citation: Konstas AG, Quaranta L, Katsanos A, Riva I, Tsai JC, Giannopoulos T, Voudouragkaki IC, Paschalinou E, Floriani I, Haidich AB. Twenty-four hour efficacy with preservative free tafluprost compared with latanoprost in patients with primary open angle glaucoma or ocular hypertension. Br J Ophthalmol. 2013 Dec;97(12):1510-5. doi: 10.1136/bjophthalmol-2012-303026. Epub 2013 May 16.