Evaluation of the tolerance and efficacy of T2347 in patients with glaucoma or ocular hypertension, stabilized with Xalacom® or generics

Phase 1

Conditions: glaucoma, ocular hypertension
MedDRA version: 17.0 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension System Organ Class: 10015919 - Eye disorders
Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

Registration Number: EUCTR2013-005222-29-GB

Lead Sponsor: aboratoires THÉA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 210

Inclusion Criteria

Patient will be eligible for inclusion in this study if all these criteria are respected at the inclusion visit:
-Signed and dated informed consent,
-Male or female aged = 18 years old,
-Both eyes with open angle glaucoma or ocular hypertension already treated and controlled by Xalacom® or generics since at least 2 months.
-IOP = 18 mmHg in both eyes
- History of IOP insufficiently controlled with first-line monotherapy based on the investigator judgement (e.g. non reaching the target IOP)
- History of an add-on IOP reduction with Xalacom® or generics (fixed combination latanoprost 0.005% + timolol 0.5% preserved eye drops) in comparison with first- line treatment
-Corneal thickness = 500 µm and = 580 µm in both eyes.
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 168
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

Exclusion Criteria

Ophthalmic exclusion criteria (in either eye)
-Fundoscopy not performed or not available within the 6 months before inclusion visit.
-Visual field (VF) not performed or not available within the 6 months before inclusion visit.
-Significant worsening according to the two last VF (minimum 6 months between these 2 VF)
-Advanced stage of glaucoma:
•Absolute defect in the ten degrees central point of the visual field.
•Severe visual field loss according to the investigator’s best judgement.
•Risk of visual field worsening as a consequence of participation in the trial according to the investigator’s best judgement.
-Best far corrected visual acuity = 1/10.
-History of trauma, infection, clinically significant inflammation within the 3 months before inclusion visit.
-Ongoing or known history of ocular seasonal and perennial allergy (SAC, PAC) and/or uveitis and/or viral infection.
-Presence of at least one severe objective sign among the following:
• Hyperaemia (Grade 5)
• Superficial punctate keratitis (Grade 3)
• Blepharitis (Grade 3)
-Severe dry eye (defined by severe epithelial erosions of the cornea and/or use of dry eye medication with a frequency exceeding 8 instillations / day).
-Corneal ulceration.
-Palpebral abnormalities not related to medical treatment study and incompatible with a good evaluation.
-History of corneal refractive surgery.
-Any abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination or corneal refractive surgery.

The protocol also defines other exclusion criteria such as systemic/non ophthalmic exclusion criteria, specific exclusion criteria for women, exclusion criteria related to general conditions and exclusion criteria related to previous and concomitant medications/ non-product therapies.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The first objective of the study is to demonstrate the non-inferiority of T2347 unpreserved eye drops compared with Xalacom® on change in mean IOP at 9.00 am (± 1 hour) between the baseline (Day 0) and Day 84 in the worse eye.;<br> Secondary Objective: The secondary objective is the evaluation of the efficacy and safety by mean of secondary efficacy and safety criteria. Those criteria are explicitly mentioned in the study protocol.<br> ;Primary end point(s): The primary efficacy endpoint is the change from baseline in mean IOP (average of the 2 or 3 recording values) on Day 84 in the worse eye.;Timepoint(s) of evaluation of this end point: Day 84

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Secondary key efficacy variables:<br> - Change from baseline in mean IOP<br> - Global assessment of efficacy by the investigator<br> ;Timepoint(s) of evaluation of this end point: Day 42 and day 84

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