Efficacy and Safety assessment of T2345 unpreserved eyedrops versus Xalatan® in ocular hypertensive or glaucomatous patients.Phase III study, multicentre, international, randomised, investigator-masked, 2 parallel groups, versus Reference product, in 400 evaluable patients treated during 3 months.
- Conditions
- The study population is suffering from glaucoma.MedDRA version: 9.1Level: LLTClassification code 10018304Term: GlaucomaMedDRA version: 9.1Level: PTClassification code 10018304Term: Glaucoma
- Registration Number
- EUCTR2009-011157-41-FR
- Lead Sponsor
- laboratoires 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 (since 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
? and 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 with:
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The protocol defined the primary efficacy variable as change in IOP at 9.00 am (± 1 hour) between the baseline Day 0 and Day 84 in the worse eye (or in the right eye in case of no IOP difference between both eyes) or the assessment at the last attended visit after baseline ??(the Day 84 visit, or if it is missing, the Day 42 visit or Day 15 visit). ;Secondary Objective: The comparison of both products will be performed on the following variables.<br>Clinical efficacy<br>Ocular and systemic safety criteria<br><br>;Primary end point(s): Patients should be withdrawn from the study if, in the opinion of the investigator, there is:<br>•Any situation or condition which puts the patient at significant risk.<br>•Ocular hypertension or glaucoma judged by the investigator as not stabilised by the treatment during the study.<br>
- Secondary Outcome Measures
Name Time Method