Ocular Hypertension Glaucoma
Conditions
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
Interventions
COMBINATION_PRODUCTBimatoprost Timolol (T4030)
Eye drop
COMBINATION_PRODUCTBimatoprost Timolol (Ganfort)
Eye drop
Sponsors
Laboratoires Thea
Study design
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
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOP assessment | Week 12 | The primary efficacy endpoint is the change from Baseline (Day 1) to Week 12 in IOP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Sign | Week 6 Week 12 | Ocular sign will be assessed through slit lamp examination at each visits |
Countries
Bulgaria
Outcome results
None listed