NCT04898387CompletedPhase 3
Efficacy and Safety Assessment of T4030 Eye Drops Versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Laboratoires Thea
- Enrollment
- 554
- Locations
- 1
- Primary Endpoint
- IOP assessment
Study Overview
Brief Summary
To demonstrate the non-inferiority of T4030 unpreserved eye drops compared to Ganfort® UD in terms of efficacy.
Detailed Description
Efficacy Parameters IOP assessment in each eye
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
The 2 different treatment kits should be identical in external packaging in order to respect the masked evaluation for efficacy and safety.
The identity of the IMP given to each patient will not be known by the masked investigator
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Informed consent signed and dated*
- •Patient aged ≥18 years old
- •Both eyes with a central corneal thickness assessment ≥500 µm and ≤600 μm a
- •Both eyes with diagnosed ocular hypertension or open angle glaucoma
Exclusion Criteria
- •History of narrow angle and/or angle closure glaucoma
- •Advanced stage of glaucoma
Arms & Interventions
T4030 Group
Experimental
Intervention: Bimatoprost Timolol (T4030) (Combination Product)
Ganfort Group
Active Comparator
Intervention: Bimatoprost Timolol (Ganfort) (Combination Product)
Outcomes
Primary Outcomes
IOP assessment
Time Frame: Week 12
The primary efficacy endpoint is the change from Baseline (Day 1) to Week 12 in IOP
Secondary Outcomes
- Ocular Sign(Week 6 Week 12)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Active, not recruiting
Phase 1
Efficacy and safety assessment of T4030 eye drops (unpreserved fixed combination of bimatoprost 0.01% and timolol 0.1% or 0.5%) versus Ganfort® UD (Unit Dose) in ocular hypertensive or glaucomatous patients.Glaucoma, ocular hypertensionMedDRA version: 20.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersEUCTR2017-002823-46-ATaboratoires THÉA; Research and Development Department143
Active, not recruiting
Phase 1
Efficacy and safety assessment of T4030 eye drops (unpreserved fixed combination of bimatoprost 0.01% and timolol 0.1% or 0.5%) versus Ganfort® UD (Unit Dose) in ocular hypertensive or glaucomatous patients.Glaucoma, ocular hypertensionMedDRA version: 20.0 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension System Organ Class: 10015919 - Eye disordersEUCTR2017-002823-46-HUaboratoires THÉA; Research and Development Department108
Active, not recruiting
Phase 1
Efficacy and safety assessment of T4030 eye drops (unpreserved fixed combination of bimatoprost 0.01% and timolol 0.1% or 0.5%) versus Ganfort® UD (Unit Dose) in ocular hypertensive or glaucomatous patients.Glaucoma, ocular hypertensionMedDRA version: 20.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersEUCTR2017-002823-46-BEaboratoires THÉA; Research and Development Department143
Active, not recruiting
Phase 1
Efficacy and Safety Assessment of T4030 Eye Drops versus Ganfort® UDin Ocular Hypertensive or Glaucomatous Patients.Primary open-angle glaucoma or Ocular hypertensionMedDRA version: 20.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersEUCTR2020-003979-18-HUaboratoires THEA500
Active, not recruiting
Phase 1
Efficacy and Safety Assessment of T4030 Eye Drops versus Ganfort® UDin Ocular Hypertensive or Glaucomatous Patients.Primary open-angle glaucoma or Ocular hypertensionMedDRA version: 20.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersEUCTR2020-003979-18-FRaboratoires THEA500