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

This study has been completed.
Sponsor:
Collaborator:
Aristotle University Of Thessaloniki
Information provided by (Responsible Party):
Luciano Quaranta, MD, Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier:
NCT01162603
First received: July 13, 2010
Last updated: May 5, 2013
Last verified: May 2013

July 13, 2010
May 5, 2013
March 2011
April 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01162603 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Latanoprost Versus Tafluprost: 24-hour Intraocular Pressure (IOP)
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
  • 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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Primary Open Angle Glaucoma
  • Ocular Hypertension
  • 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
  • Drug: LATANOPROST 0.005% EYEDROPS
    Latanoprost 0.005% preservative-added ophthalmic solution
    Other Name: Latanoprost 0.005% eyedrops generic drug
  • 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.
    Interventions:
    • Device: Goldmann and Perkins applanation tonometry
    • Drug: TAFLUPROST 0.0015% EYEDROPS
  • 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.
    Interventions:
    • Device: Goldmann and Perkins applanation tonometry
    • Drug: LATANOPROST 0.005% EYEDROPS

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Greece,   Italy
 
NCT01162603
AOBS-SAF-01
No
Luciano Quaranta, MD, Azienda Ospedaliera Spedali Civili di Brescia
Azienda Ospedaliera Spedali Civili di Brescia
Aristotle University Of Thessaloniki
Principal Investigator: Luciano Quaranta, MD Università degli Studi di Brescia
Azienda Ospedaliera Spedali Civili di Brescia
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP