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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-04-30

Brief Summary

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* 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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Detailed Description

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Conditions

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Primary Open Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Goldmann and Perkins applanation tonometry

Intervention Type 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

TAFLUPROST 0.0015% EYEDROPS

Intervention Type DRUG

Tafluprost 0.0015% preservative-free ophthalmic solution

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.

Group Type ACTIVE_COMPARATOR

Goldmann and Perkins applanation tonometry

Intervention Type 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

LATANOPROST 0.005% EYEDROPS

Intervention Type DRUG

Latanoprost 0.005% preservative-added ophthalmic solution

Interventions

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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

Intervention Type DEVICE

TAFLUPROST 0.0015% EYEDROPS

Tafluprost 0.0015% preservative-free ophthalmic solution

Intervention Type DRUG

LATANOPROST 0.005% EYEDROPS

Latanoprost 0.005% preservative-added ophthalmic solution

Intervention Type DRUG

Other Intervention Names

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Saflutan, Merck Sharp & Dhome Latanoprost 0.005% generic drug Saflutan, MSD Latanoprost 0.005% eyedrops generic drug

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No