Glaucoma
Conditions
Brief summary
The purpose of this study is to assess the efficacy and safety of T2345 versus active comparator.
Interventions
DRUGT2345
One drop of T2345
DRUGProstaglandin
One drop
Sponsors
Laboratoires Thea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients diagnosed with glaucoma
Exclusion criteria
* Under 18.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) | Day 0 and Day 84 | The worse eye is defined as: * If both eyes are eligible the eye with highest Intraocular pressure (IOP) at Day 0 (D0). If both eyes have the same IOP at D0 the worse eye is the right eye. * If only one eye is eligible this eye is the worse eye. * If neither eye is eligible the worse eye is defined as the eye with the highest IOP at D0. If both eyes have the same IOP at D0 the worse eye is the right eye. |
Countries
France
Participant flow
Pre-assignment details
Included patients= 404 patients but 2 patients without available data after Day 0. These 2 patients were excluded from the analyses sets.
Participants by arm
| Arm | Count |
|---|---|
| T2345 One drop of T2345
T2345: One drop of T2345 at 9.00pm. | 213 |
| Prostaglandin One drop of prostaglandin
Prostaglandin: One drop of prostaglandin at 9.00pm | 189 |
| Total | 402 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Non respect of one of inclusion criteria | 2 | 1 |
| Overall Study | use of commercial drug instead of study | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | T2345 | Prostaglandin | Total |
|---|---|---|---|
| Age, Continuous | 63.9 years STANDARD_DEVIATION 11.4 | 65.7 years STANDARD_DEVIATION 11.7 | 64.7 years STANDARD_DEVIATION 11.5 |
| Region of Enrollment Belgium | 14 participants | 8 participants | 22 participants |
| Region of Enrollment France | 104 participants | 93 participants | 197 participants |
| Region of Enrollment Italy | 25 participants | 22 participants | 47 participants |
| Region of Enrollment Portugal | 15 participants | 15 participants | 30 participants |
| Region of Enrollment Spain | 8 participants | 7 participants | 15 participants |
| Region of Enrollment Tunisia | 47 participants | 44 participants | 91 participants |
| Sex: Female, Male Female | 114 Participants | 86 Participants | 200 Participants |
| Sex: Female, Male Male | 99 Participants | 103 Participants | 202 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 213 | 0 / 189 |
| serious Total, serious adverse events | 5 / 213 | 1 / 189 |
Outcome results
Primary
Change From Baseline in Intraocular Pressure (IOP)
The worse eye is defined as: * If both eyes are eligible the eye with highest Intraocular pressure (IOP) at Day 0 (D0). If both eyes have the same IOP at D0 the worse eye is the right eye. * If only one eye is eligible this eye is the worse eye. * If neither eye is eligible the worse eye is defined as the eye with the highest IOP at D0. If both eyes have the same IOP at D0 the worse eye is the right eye.
Time frame: Day 0 and Day 84
Population: mITT set : All randomised patients, with at least one eligible eye, having received at least one dose of the Investigational Medicinal Product, and for whom any follow-up IOP recording was available for the worse eye.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T2345 | Change From Baseline in Intraocular Pressure (IOP) | -8.6 mmHg | Standard Deviation 2.6 |
| Prostaglandin | Change From Baseline in Intraocular Pressure (IOP) | -9.0 mmHg | Standard Deviation 2.4 |