Monoprost® compared with Lumigan® in POA glaucoma/ocular hypertension
Research type
Research Study
Full title
Safety and Efficacy assessment of Monoprost® (unpreserved latanoprost) in comparison with Lumigan® 0.01 % and Lumigan® 0.03% UD, in patients with open angle glaucoma or ocular hypertension, stabilized by all prostaglandin (expect Monoprost®) with ocular surface intolerance.
IRAS ID
122371
Contact name
K Sheng Lim
Contact email
Sponsor organisation
Laboratoires THÉA
Eudract number
2013-001250-10
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Are the unpreserved eye drops Monoprost less irritant and as effective as Lumigan 0.01% eye drops (preserved) and Lumigan 0.03% UD (unpreserved), in patients with glaucoma or ocular hypertension?
This study assesses the safety and efficacy of Monoprost® (0.005% latanoprost), an unpreserved unit-dose (UD) eye drop solution. It will be conducted in patients with primary open angle glaucoma or ocular hypertension who are currently being treated with the preserved eye drop solution, Lumigan® (0.01% bimatoprost)and who are showing signs and symptoms of intolerance to previous eye drop treatment. The study compares once-daily treatment with Monoprost® to Lumigan® 0.01% or unpreserved Lumigan 0.03% UD, for a period of 3 months. Preservatives can cause irritation to the surface of the eye, so the study will assess the signs and symptoms caused by the different treatments; it will also compare the safety and effectiveness of Monoprost®, which contains latanoprost as the active ingredient, to Lumigan 0.01% and Lumigan 0.03% UD eye drops, both of which contain bimatoprost as the active ingredient. The study is being conducted in 400 patients in Ophthalmology departments of hospitals in France, Germany, Switzerland and the UK. After entry into the study, patients are required to attend 3 visits to their Ophthalmologist during which routine eye investigations will be conducted, including measurement of intraocular pressure, slit-lamp (microscope) eye examination, eyesight test and fluorescein stain of surface of the eye to detect any damaged cells. Patients will also be asked to report any adverse event that they have suffered. At the end of the study, patients will be prescribed treatment for their condition by their Ophthalmologist.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
13/EM/0348
Date of REC Opinion
6 Nov 2013
REC opinion
Further Information Favourable Opinion