Latanoprost Versus Tafluprost: 24-hour Intraocular Pressure (IOP) - Full Text View

Purpose

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

Condition	Intervention	Phase
Primary Open Angle Glaucoma Ocular Hypertension	Device: Goldmann and Perkins applanation tonometry Drug: TAFLUPROST 0.0015% EYEDROPS Drug: LATANOPROST 0.005% EYEDROPS	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Tetrahydrozoline hydrochloride Boric acid Latanoprost Tafluprost

U.S. FDA Resources

Further study details as provided by Azienda Ospedaliera Spedali Civili di Brescia:

Primary Outcome Measures:

Intraocular Pressure [ Time Frame: 24-hour ] [ Designated as safety issue: No ]
Primary endpoint of this crossover trial 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.

Enrollment:	40
Study Start Date:	March 2011
Study Completion Date:	April 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: TAFLUPROST 0.0015% EYEDROPS Tafluprost 0.0015% preservative-free ophthalmic solution will be given once a day at the evening,in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. IOP values after three months of treatment will be evaluated throughout the 24-hour by the means of Goldmann and Perkins applanation tonometry.	Device: Goldmann and Perkins applanation tonometry IOP values will be assessed by the means of Goldmann or Perkins applanation tonometry at the following 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 Other Names: Saflutan, Merck Sharp & Dhome Latanoprost 0.005% generic drug Drug: TAFLUPROST 0.0015% EYEDROPS Tafluprost 0.0015% preservative-free ophthalmic solution Other Name: Saflutan, MSD
Active Comparator: LATANOPROST 0.005% EYEDROPS Latanoprost 0.005% preservative-added ophthalmic solution will be given once a day at the evening,in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. IOP values after three months of treatment will be evaluated throughout the 24-hour by the means Goldmann and Perkins applanation tonometry.	Device: Goldmann and Perkins applanation tonometry IOP values will be assessed by the means of Goldmann or Perkins applanation tonometry at the following 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 Other Names: Saflutan, Merck Sharp & Dhome Latanoprost 0.005% generic drug Drug: LATANOPROST 0.005% EYEDROPS Latanoprost 0.005% preservative-added ophthalmic solution Other Name: Latanoprost 0.005% eyedrops generic drug

Arms

Assigned Interventions

Experimental: TAFLUPROST 0.0015% EYEDROPS

Tafluprost 0.0015% preservative-free ophthalmic solution will be given once a day at the evening,in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. IOP values after three months of treatment will be evaluated throughout the 24-hour by the means of Goldmann and Perkins applanation tonometry.

Device: Goldmann and Perkins applanation tonometry

IOP values will be assessed by the means of Goldmann or Perkins applanation tonometry at the following 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

Other Names:

Saflutan, Merck Sharp & Dhome
Latanoprost 0.005% generic drug

Drug: TAFLUPROST 0.0015% EYEDROPS

Tafluprost 0.0015% preservative-free ophthalmic solution

Other Name: Saflutan, MSD

Active Comparator: LATANOPROST 0.005% EYEDROPS

Latanoprost 0.005% preservative-added ophthalmic solution will be given once a day at the evening,in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. IOP values after three months of treatment will be evaluated throughout the 24-hour by the means Goldmann and Perkins applanation tonometry.

Device: Goldmann and Perkins applanation tonometry

IOP values will be assessed by the means of Goldmann or Perkins applanation tonometry at the following 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

Other Names:

Saflutan, Merck Sharp & Dhome
Latanoprost 0.005% generic drug

Drug: LATANOPROST 0.005% EYEDROPS

Latanoprost 0.005% preservative-added ophthalmic solution

Other Name: Latanoprost 0.005% eyedrops generic drug

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162603

Locations

Greece
Glaucoma Unit, 1st University Department of Ophthalmology, Aristotle University, AHEPA Hospital
Thessaloniki, Greece, 54636
Italy
USVD "Centro per lo studio del glaucoma" Spedali civili di Brescia
Brescia, Italy, 25123

Sponsors and Collaborators

Azienda Ospedaliera Spedali Civili di Brescia

Aristotle University Of Thessaloniki

Investigators

Principal Investigator:

Luciano Quaranta, MD

Università degli Studi di Brescia

More Information

Publications:

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 Jun 16; [Epub ahead of print]

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.

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.

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.

Responsible Party:	Luciano Quaranta, MD, Associate Professor in Ophthalmology, Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier:	NCT01162603 History of Changes
Other Study ID Numbers:	AOBS-SAF-01
Study First Received:	July 13, 2010
Last Updated:	May 5, 2013
Health Authority:	Greece: Ethics Committee Italy: Ethics Committee

Additional relevant MeSH terms:

Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Tetrahydrozoline
Latanoprost
Nasal Decongestants

Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 19, 2013

Latanoprost Versus Tafluprost: 24-hour Intraocular Pressure (IOP) (SAF-24H-IOP)