Efficacy and Safety assessment of T2345 unpreserved eyedrops versus Xalatan® in ocular hypertensive or glaucomatous patients.Phase III study, international, multicentre, randomised, investigator-masked, 2 parallel groups, versus reference product, in 360 evaluable patients treated for 3 months.
- Conditions
- The study population will be suffering from open angle glaucoma or hypertension.MedDRA version: 12.0Level: LLTClassification code 10030348Term: Open angle glaucomaMedDRA version: 12.0Level: LLTClassification code 10030043Term: Ocular hypertension
- Registration Number
- EUCTR2009-011157-41-BE
- Lead Sponsor
- aboratoires Théa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
Patients will be eligible for inclusion if all these criteria are respected:
At Selection Visit:
Signed and dated informed consent,
Male or female aged from = 18 to = 90 years old,
Association of the following criteria for the eligible eye(s):
Chronic primary open angle glaucoma or chronic ocular hypertension
Already treated and controlled (for at least one year) by a monotherapy of
Xalatan® defined by:
Stable IOP (= 18 mmHg) AND
Stable visual field defined by two available visual field:
the penultimate visual field performed within the last 18 months
the last visual field performed within the last 6 months
with an interval of at least 6 months between both visual fields.
Corneal thickness = 510 µm and = 560 µm.
At Inclusion Visit:
IOP:
IOP < 34 mmHg in BOTH eyes AND
IOP = 22 mmHg in the eligible eye(s).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients fulfilling at the selection visit ONE OR MORE of the following non inclusion criteria will not be included in the study:
Ophthalmic non-inclusion criteria (in either eye):
Any secondary ocular hypertension (such as congenital glaucoma, closed-angle glaucoma, secondary glaucoma, glaucoma after cataract surgery,…).
Any severe glaucoma defined by:
an advanced cupping AND/OR
for the visual field:
A severe field loss AND/OR
A risk of visual field worsening as a consequence of participation
in the trial according to the investigator’s best judgement AND/OR
An absolute defect in the ten degree central point.
Best far corrected visual acuity = 1/10.
Aphakia.
Known history of ocular allergy and/or blepharitis and/or uveitis.
History of traumatism, infection, ocular inflammation within the 3 months before the selection visit.
History of refractive surgery.
Severe dry eye (for example, clinically relevant superficial punctuate keratitis, epithelial erosions of the cornea and/or use of dry eye medication with a frequency exceeding 8 instillations/day).
Any abnormality preventing accurate assessment e.g. reliable applanation tonometry, visual field examination.
Systemic/non ophthalmic non-inclusion criteria
General history:
Non controlled asthma.
Any medical or surgical history, disorder or disease such as acute or chronic
severe organic disease: hepatic, endocrine, neoplasic, haematological;
immunosuppressive, infectious diseases, severe psychiatric illness, relevant
cardiovascular abnormalities, etc and/or any complicating factor or structural
abnormality, judged by the investigator to be incompatible with the study.
Known allergic hypersensitivity history to one of the components of the study medications or to test products.
Specific non-inclusion criteria for women:
Pregnancy, lactation.
Women without an effective method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant) or women not hysterectomised, menopaused or surgically sterilized.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method