Open Angle Glaucoma, Ocular Hypertension
Conditions
Brief summary
The objective of the study is to assess the efficacy and safety of T2347 (Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops) versus Xalacom® in ocular hypertensive or glaucomatous patients initially treated, stabilised by Xalacom® or generics (fixed combination Latanoprost 0.005% + Timolol 0.5% preserved eye drops).
Detailed description
Phase III, international, multicentre, randomised, investigator masked, 3 month duration, 2 parallel groups, 2 X 97 evaluable patients
Interventions
DRUGT2347
T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers.
DRUGXalacom
Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container.
Sponsors
Laboratoires Thea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 (fixed combination Latanoprost 0.005% + Timolol 0.5% preserved eye drops) 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.
Exclusion criteria
* Ophthalmic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-inferiority of T2347 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 | Day 84 | 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. Two relevant time points are considered for this primary criteria: D0 and Day 84. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| T2347 T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops
T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers. | 127 |
| Xalacom Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops
Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container. | 115 |
| Total | 242 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | left eye was not eligible | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 5 |
Baseline characteristics
| Characteristic | T2347 | Xalacom | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 74 Participants | 72 Participants | 146 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants | 43 Participants | 96 Participants |
| Age, Continuous | 65.8 years STANDARD_DEVIATION 10.8 | 67.2 years STANDARD_DEVIATION 10.6 | 66.3 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 80 Participants | 69 Participants | 149 Participants |
| Sex: Female, Male Male | 47 Participants | 46 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 127 | 0 / 115 |
| serious Total, serious adverse events | 0 / 127 | 1 / 115 |
Outcome results
Primary
Non-inferiority of T2347 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
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. Two relevant time points are considered for this primary criteria: D0 and Day 84.
Time frame: Day 84
Population: The primary efficacy analysis (mean change in IOP from baseline to Day 84) was performed on the mITT set (236 patients).~mITT set: All ITT patients with at least one baseline and one post-randomisation efficacy assessment following study treatment.~242 patients described in the participant flow correpsond to the ITT \& Safety set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| T2347 | Non-inferiority of T2347 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 | -0.51 mm Hg | Standard Error 0.18 |
| Xalacom | Non-inferiority of T2347 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 | -0.52 mm Hg | Standard Error 0.19 |
95% CI: [-0.57, 0.43]Mixed Models Analysis
95% CI: [-0.69, 0.31]Mixed Models Analysis