Primary Open Angle Glaucoma
Conditions
Brief summary
The purpose of this study is to assess the pharmacokinetics, efficacy and safety of T2345 versus an active comparator.
Interventions
DRUGT2345
One drop at 8.00pm.
DRUGProstaglandin
One drop at 8.00pm.
Sponsors
Laboratoires Thea
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Untreated bilateral newly diagnosed patients with primary open angle glaucoma
Exclusion criteria
* Any ocular hypertension other than chronic open angle glaucoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intra Ocular Pressure (IOP) at 8.00am | Day 42 and Day 84 (8.00am for the IOP) | Efficacy criteria at 8.00am on Day 42 and on Day84. Worse Eye= the eligible eye (with at least one out of the 4 individual IOP values on Day 0 \>= 22 and \<=30mmHg) with the highest individual IOP at 8.00am on Day 0. If both eyes are eligible and have the same individual IOP at 8.00am on Day 0, the right eye is considered. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prostaglandin/T2345 One drop at 8.00pm. | 15 |
| T2345/Prostaglandin One drop at 8.00pm. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Prostaglandin/T2345 | T2345/Prostaglandin | Total |
|---|---|---|---|
| Age, Continuous | 51.1 years STANDARD_DEVIATION 12.6 | 50.2 years STANDARD_DEVIATION 13.4 | 50.7 years STANDARD_DEVIATION 12.8 |
| Region of Enrollment India | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 2 Participants | 7 Participants | 9 Participants |
| Sex: Female, Male Male | 13 Participants | 8 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 1 / 30 |
Outcome results
Primary
Mean Intra Ocular Pressure (IOP) at 8.00am
Efficacy criteria at 8.00am on Day 42 and on Day84. Worse Eye= the eligible eye (with at least one out of the 4 individual IOP values on Day 0 \>= 22 and \<=30mmHg) with the highest individual IOP at 8.00am on Day 0. If both eyes are eligible and have the same individual IOP at 8.00am on Day 0, the right eye is considered.
Time frame: Day 42 and Day 84 (8.00am for the IOP)
Population: Per protocol (PP) set: All patients enrolled in the study for whom any follow-up efficacy information was evaluable and who did not show any major protocol deviation that could affect the efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prostaglandin/T2345 | Mean Intra Ocular Pressure (IOP) at 8.00am | IOP at 8am for the worse eye (PPset) D42 | 16.6 mmHg | Standard Deviation 3 |
| Prostaglandin/T2345 | Mean Intra Ocular Pressure (IOP) at 8.00am | IOP at 8am for the worse eye (PPset) D84 | 17 mmHg | Standard Deviation 2.2 |
| T2345/Prostaglandin | Mean Intra Ocular Pressure (IOP) at 8.00am | IOP at 8am for the worse eye (PPset) D42 | 16.3 mmHg | Standard Deviation 2.3 |
| T2345/Prostaglandin | Mean Intra Ocular Pressure (IOP) at 8.00am | IOP at 8am for the worse eye (PPset) D84 | 15.7 mmHg | Standard Deviation 2.9 |