glaucoma, ocular hypertension MedDRA version: 17.0 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Code: T2347 (latanoprost 0.005% + timolol 0.5%)
Pharmaceutical Form: Eye drops, solution in single-dose container
INN or Proposed INN: Timolol
Other descriptive name: TIMOLOL
Concentration uni
Sponsors
Laboratoires THÉA
Eligibility
Sex/Gender
All
Inclusion criteria
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 = 600 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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. ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary key efficacy variables: - Change from baseline in mean IOP - Global assessment of efficacy by the investigator;Timepoint(s) of evaluation of this end point: Day 42 and day 84 | — |
Countries
Belgium, Estonia, Germany, Hungary, Latvia, Spain, United Kingdom
Contacts
Public ContactResearch and Development Department
Laboratoires Thea
Outcome results
None listed