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

Primary Purpose

Primary Open Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Goldmann and Perkins applanation tonometry
TAFLUPROST 0.0015% EYEDROPS
LATANOPROST 0.005% EYEDROPS
Sponsored by
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAFLUPROST 0.0015% EYEDROPS

LATANOPROST 0.005% EYEDROPS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Intraocular Pressure
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.

Secondary Outcome Measures

Full Information

First Posted
July 13, 2010
Last Updated
May 5, 2013
Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Collaborators
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT01162603
Brief Title
Latanoprost Versus Tafluprost: 24-hour Intraocular Pressure (IOP)
Acronym
SAF-24H-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

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Collaborators
Aristotle University Of Thessaloniki

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAFLUPROST 0.0015% EYEDROPS
Arm Type
Experimental
Arm Description
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.
Arm Title
LATANOPROST 0.005% EYEDROPS
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Goldmann and Perkins applanation tonometry
Other Intervention Name(s)
Saflutan, Merck Sharp & Dhome, Latanoprost 0.005% generic drug
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
TAFLUPROST 0.0015% EYEDROPS
Other Intervention Name(s)
Saflutan, MSD
Intervention Description
Tafluprost 0.0015% preservative-free ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
LATANOPROST 0.005% EYEDROPS
Other Intervention Name(s)
Latanoprost 0.005% eyedrops generic drug
Intervention Description
Latanoprost 0.005% preservative-added ophthalmic solution
Primary Outcome Measure Information:
Title
Intraocular Pressure
Description
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.
Time Frame
24-hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciano Quaranta, MD
Organizational Affiliation
Università degli Studi di Brescia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glaucoma Unit, 1st University Department of Ophthalmology, Aristotle University, AHEPA Hospital
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
USVD "Centro per lo studio del glaucoma" Spedali civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
20545217
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.
Results Reference
background
PubMed Identifier
20420586
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.
Results Reference
background
PubMed Identifier
20390038
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.
Results Reference
background
PubMed Identifier
20553122
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.
Results Reference
result
PubMed Identifier
23681371
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.
Results Reference
derived

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

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