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

NCT01162603 | Completed Phase 4

• 1 other identifier: AOBS-SAF-01
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

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

Conditions

Primary Open Angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  24-hour

Study Arms (2)

TAFLUPROST 0.0015% EYEDROPS

EXPERIMENTAL

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; Drug: TAFLUPROST 0.0015% EYEDROPS

LATANOPROST 0.005% EYEDROPS

ACTIVE COMPARATOR

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; Drug: LATANOPROST 0.005% EYEDROPS

Interventions

Goldmann and Perkins applanation tonometry DEVICE

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

Also known as: Saflutan, Merck Sharp & Dhome, Latanoprost 0.005% generic drug

LATANOPROST 0.005% EYEDROPS; TAFLUPROST 0.0015% EYEDROPS

TAFLUPROST 0.0015% EYEDROPS DRUG

Tafluprost 0.0015% preservative-free ophthalmic solution

Also known as: Saflutan, MSD

TAFLUPROST 0.0015% EYEDROPS

LATANOPROST 0.005% EYEDROPS DRUG

Latanoprost 0.005% preservative-added ophthalmic solution

Also known as: Latanoprost 0.005% eyedrops generic drug

LATANOPROST 0.005% EYEDROPS

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead
• Aristotle University Of Thessaloniki: collaborator

Study Sites (2)

Glaucoma Unit, 1st University Department of Ophthalmology, Aristotle University, AHEPA Hospital

Thessaloniki, 54636, Greece

Location

USVD "Centro per lo studio del glaucoma" Spedali civili di Brescia

Brescia, 25123, Italy

Location

Related Publications (5)

• 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.

  PMID: 20545217 BACKGROUND

• 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.

  PMID: 20420586 BACKGROUND

• 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.

  PMID: 20390038 BACKGROUND

• 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.

  PMID: 20553122 RESULT

• 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.

  PMID: 23681371 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

tafluprost; Ophthalmic Solutions; Latanoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Luciano Quaranta, MD

  Università degli Studi di Brescia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Ophthalmology

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 14, 2010
• Study Start: March 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 7, 2013

Record last verified: 2013-05

Locations

GR (1); IT (1)