Glaucoma, Ocular Hypertension
Conditions
Brief summary
The main purpose is to compare the ocular hypotensive efficacy and safety of two concentrations of T4090 (Kinezodianone R HCl 0.2% and 0.3%) ophthalmic solution with Rhopressa® ophthalmic solution
Interventions
DRUGT4090 0.2%
1 drop in the conjunctival cul-de-sac of each eye once daily at 8:00 PM (±1 hour) from Day 1 to the day before the End of treatment visit (Visit #5 - Week 7).
DRUGT4090 0.3%
1 drop in the conjunctival cul-de-sac of each eye once daily at 8:00 PM (±1 hour) from Day 1 to the day before the End of treatment visit (Visit #5 - Week 7).
DRUGRhopressa®
1 drop in the conjunctival cul-de-sac of each eye once daily at 8:00 PM (±1 hour) from Day 1 to the day before the End of treatment visit (Visit #5 - Week 7).
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
Main Inclusion Criteria: * Patient (male or female) ≥18 years old * Patient with Open Angle Glaucoma or Ocular Hypertension in both eyes * Informed consent dated and signed. Main
Exclusion criteria
* Secondary Open Agle Glaucoma (ex. Pseudoexfoliation, Pigmentary glaucoma) * Advanced stage of glaucoma * History of ocular trauma, eye infection, or/and ocular clinically significant inflammation within the 6 previous months. * Known or suspected hypersensitivity to one of the components of the IMPs or other product used in the clinical study * Pregnancy (confirmed with a positive urine pregnancy test) or breast-feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Diurnal IOP | The primary efficacy endpoint is the change from baseline (D1) at Week 7 in the mean diurnal IOP in the study eye. | IOP measurement with calibrated Goldmann applanation tonometer in each eye at three time points (8:00 AM; 10:00 AM; 4:00 PM) by the Investigator. Mean diurnal is calculated from these three timepoints. |
Countries
United States
Participant flow
Recruitment details
161 patients randomized and 159 patients treated. 2 Patients did not receive a treatment due to randomization error in IRT.
Participants by arm
| Arm | Count |
|---|---|
| T4090 0.2% Preservative-free Kinezodianone R HCl 0.2%, ophthalmic solution. | 53 |
| T4090 0.3% Preservative-free Kinezodianone R HCl 0.3%, ophthalmic solution. | 53 |
| Rhopressa® Preserved netarsudil 0.02%, ophthalmic solution | 53 |
| Total | 159 |
Baseline characteristics
| Characteristic | T4090 0.2% | T4090 0.3% | Rhopressa® | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 44 Participants | 38 Participants | 41 Participants | 123 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 15 Participants | 12 Participants | 36 Participants |
| Age, Continuous | 71.4 years STANDARD_DEVIATION 9.37 | 69.2 years STANDARD_DEVIATION 9.45 | 70.3 years STANDARD_DEVIATION 10.15 | 70.3 years STANDARD_DEVIATION 9.64 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 11 Participants | 11 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 42 Participants | 42 Participants | 124 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 12 Participants | 9 Participants | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 42 Participants | 40 Participants | 42 Participants | 124 Participants |
| Region of Enrollment United States | 53 Participants | 53 Participants | 53 Participants | 159 Participants |
| Sex: Female, Male Female | 23 Participants | 31 Participants | 26 Participants | 80 Participants |
| Sex: Female, Male Male | 30 Participants | 22 Participants | 27 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 53 | 0 / 53 |
| other Total, other adverse events | 46 / 53 | 46 / 53 | 36 / 53 |
| serious Total, serious adverse events | 0 / 53 | 0 / 53 | 1 / 53 |
Outcome results
Primary
Mean Diurnal IOP
IOP measurement with calibrated Goldmann applanation tonometer in each eye at three time points (8:00 AM; 10:00 AM; 4:00 PM) by the Investigator. Mean diurnal is calculated from these three timepoints.
Time frame: The primary efficacy endpoint is the change from baseline (D1) at Week 7 in the mean diurnal IOP in the study eye.
Population: Primary estimand - Full Set Analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T4090 0.2% | Mean Diurnal IOP | -5.07 mmHg | Standard Deviation 2.75 |
| T4090 0.3% | Mean Diurnal IOP | -4.73 mmHg | Standard Deviation 2.94 |
| Rhopressa® | Mean Diurnal IOP | -4.6 mmHg | Standard Deviation 3.06 |
p-value: 0.376Mixed Models Analysis
p-value: 0.518Mixed Models Analysis