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Completed

NCT Number: NCT01162603

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

* 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

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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Saflutan, Merck Sharp & Dhome, Latanoprost 0.005% generic drug

TAFLUPROST 0.0015% EYEDROPS

Drug

Tafluprost 0.0015% preservative-free ophthalmic solution

Other names: Saflutan, MSD

LATANOPROST 0.005% EYEDROPS

Drug

Latanoprost 0.005% preservative-added ophthalmic solution

Other names: Latanoprost 0.005% eyedrops generic drug

Primary outcomes

  1. Intraocular Pressure

    Time frame: 24-hour

    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.

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Other

Collaborators

  • Aristotle University Of Thessaloniki

Registry information

Official study 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

Acronym: SAF-24H-IOP

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 14, 2010
Registry last updated
May 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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