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

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ClinicalTrials.gov Identifier: NCT01162603
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : May 7, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (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
Study Start Date : March 2011
Primary Completion Date : April 2012
Study Completion Date : April 2012


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: July 14, 2010    Key Record Dates
Last Update Posted: May 7, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Tetrahydrozoline
Pharmaceutical Solutions
Ophthalmic Solutions
Latanoprost
Antihypertensive Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents