Latanoprost Versus Tafluprost: 24-hour Intraocular Pressure (IOP)
Information source: Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Open Angle Glaucoma; Ocular Hypertension
Intervention: Goldmann and Perkins applanation tonometry (Device); TAFLUPROST 0.0015% EYEDROPS (Drug); LATANOPROST 0.005% EYEDROPS (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Azienda Ospedaliera Spedali Civili di Brescia Official(s) and/or principal investigator(s): Luciano Quaranta, MD, Principal Investigator, Affiliation: Università degli Studi di Brescia
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Intraocular Pressure
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Glaucoma Unit, 1st University Department of Ophthalmology, Aristotle University, AHEPA Hospital, Thessaloniki 54636, Greece
USVD "Centro per lo studio del glaucoma" Spedali civili di Brescia, Brescia 25123, Italy
Additional Information
Related publications: 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]. Nihon Ganka Gakkai Zasshi. 2010 May;114(5):436-43. Japanese. 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. 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.
Starting date: March 2011
Last updated: May 5, 2013
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