Status:
COMPLETED
Latanoprost Versus Tafluprost: 24-hour Intraocular Pressure (IOP)
Lead Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Collaborating Sponsors:
Aristotle University Of Thessaloniki
Conditions:
Primary Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
45+ years
Phase:
PHASE4
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 ev...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01162603
Start Date
March 1 2011
End Date
April 1 2012
Last Update
May 7 2013
Active Locations (2)
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1
Glaucoma Unit, 1st University Department of Ophthalmology, Aristotle University, AHEPA Hospital
Thessaloniki, Greece, 54636
2
USVD "Centro per lo studio del glaucoma" Spedali civili di Brescia
Brescia, Italy, 25123