Open Angle Glaucoma or Ocular Hypertension
Conditions
Brief summary
The purpose of this study is to investigate the intraocular pressure-lowering effect and the safety of DE-117 ophthalmic solution compared with Latanoprost ophthalmic solution in subjects with open angle glaucoma or ocular hypertension.
Interventions
DRUGDE-117
DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Sponsors
Santen Pharmaceutical Co., Ltd.
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
* Patients with open angle glaucoma or ocular hypertension in both eyes
Exclusion criteria
* Patients at risk of progression of visual field loss * Patients with severe visual field defect * Patients with any diseases that preclude participation in this study for safety reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Diurnal IOP at Month 3 | Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00) | The IOP (mmHg) measured in the study eye (identified at Day 1 \[baseline\]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | 09:00, 13:00, and 17:00 at Week 1, Week 6, and Month 3. | The IOP (mmHg) measured in the study eye (identified at Day 1 \[baseline\]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject. |
| Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint) | Week 1 | The IOP (mmHg) measured in the study eye (identified at Day 1 \[baseline\]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject. |
Countries
Singapore
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DE-117 Ophthalmic Solution DE-117: DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes. | 184 |
| Latanoprost Ophthalmic Solution 0.005% Latanoprost ophthalmic solution: Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes. | 185 |
| Total | 369 |
Baseline characteristics
| Characteristic | Total | DE-117 Ophthalmic Solution | Latanoprost Ophthalmic Solution 0.005% |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 89 Participants | 47 Participants | 42 Participants |
| Age, Categorical Between 18 and 65 years | 280 Participants | 137 Participants | 143 Participants |
| Age, Continuous | 53.6 years STANDARD_DEVIATION 13 | 54.6 years STANDARD_DEVIATION 12.9 | 52.6 years STANDARD_DEVIATION 13.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 339 Participants | 166 Participants | 173 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 25 Participants | 14 Participants | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 369 Participants | 184 Participants | 185 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment India | 201 participants | 98 participants | 103 participants |
| Region of Enrollment Singapore | 26 participants | 17 participants | 9 participants |
| Region of Enrollment South Korea | 41 participants | 21 participants | 20 participants |
| Region of Enrollment Taiwan | 101 participants | 48 participants | 53 participants |
| Sex: Female, Male Female | 175 Participants | 78 Participants | 97 Participants |
| Sex: Female, Male Male | 194 Participants | 106 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 185 | 0 / 185 |
| other Total, other adverse events | 74 / 185 | 55 / 185 |
| serious Total, serious adverse events | 2 / 185 | 2 / 185 |
Outcome results
Primary
Mean Diurnal IOP at Month 3
The IOP (mmHg) measured in the study eye (identified at Day 1 \[baseline\]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.
Time frame: Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00)
Population: One subject in the DE-117 arm was excluded from the FAS due to no data for at least 1 post-baseline IOP measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DE-117 Ophthalmic Solution | Mean Diurnal IOP at Month 3 | 17.5 mmHg | Standard Error 0.25 |
| Latanoprost Ophthalmic Solution 0.005% | Mean Diurnal IOP at Month 3 | 16.8 mmHg | Standard Error 0.25 |
Secondary
IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint)
The IOP (mmHg) measured in the study eye (identified at Day 1 \[baseline\]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.
Time frame: 09:00, 13:00, and 17:00 at Week 1, Week 6, and Month 3.
Population: One subject in the DE-117 arm was excluded from the FAS due to no data for at least 1 post-baseline IOP measurement.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| DE-117 Ophthalmic Solution | IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Week 1 13:00 | 18.4 mmHg | Standard Error 0.28 |
| DE-117 Ophthalmic Solution | IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Week 6 17:00 | 17.5 mmHg | Standard Error 0.26 |
| DE-117 Ophthalmic Solution | IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Week 6 09:00 | 17.8 mmHg | Standard Error 0.26 |
| DE-117 Ophthalmic Solution | IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Month 3 09:00 | 17.9 mmHg | Standard Error 0.27 |
| DE-117 Ophthalmic Solution | IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Week 1 17:00 | 18.0 mmHg | Standard Error 0.28 |
| DE-117 Ophthalmic Solution | IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Month 3 13:00 | 17.2 mmHg | Standard Error 0.25 |
| DE-117 Ophthalmic Solution | IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Week 6 13:00 | 17.6 mmHg | Standard Error 0.27 |
| DE-117 Ophthalmic Solution | IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Month 3 17:00 | 17.2 mmHg | Standard Error 0.26 |
| DE-117 Ophthalmic Solution | IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Week 1 09:00 | 19.0 mmHg | Standard Error 0.28 |
| Latanoprost Ophthalmic Solution 0.005% | IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Month 3 17:00 | 16.7 mmHg | Standard Error 0.27 |
| Latanoprost Ophthalmic Solution 0.005% | IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Week 1 09:00 | 18.8 mmHg | Standard Error 0.29 |
| Latanoprost Ophthalmic Solution 0.005% | IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Week 1 13:00 | 18.4 mmHg | Standard Error 0.29 |
| Latanoprost Ophthalmic Solution 0.005% | IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Week 1 17:00 | 18.3 mmHg | Standard Error 0.28 |
| Latanoprost Ophthalmic Solution 0.005% | IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Week 6 09:00 | 17.4 mmHg | Standard Error 0.26 |
| Latanoprost Ophthalmic Solution 0.005% | IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Week 6 13:00 | 17.2 mmHg | Standard Error 0.27 |
| Latanoprost Ophthalmic Solution 0.005% | IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Week 6 17:00 | 17.1 mmHg | Standard Error 0.27 |
| Latanoprost Ophthalmic Solution 0.005% | IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Month 3 09:00 | 17.0 mmHg | Standard Error 0.27 |
| Latanoprost Ophthalmic Solution 0.005% | IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Month 3 13:00 | 16.7 mmHg | Standard Error 0.26 |
Secondary
Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint)
The IOP (mmHg) measured in the study eye (identified at Day 1 \[baseline\]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.
Time frame: Week 1
Population: One subject in the DE-117 arm was excluded from the FAS due to no data for at least 1 post-baseline IOP measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DE-117 Ophthalmic Solution | Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint) | 18.5 mmHg | Standard Error 0.26 |
| Latanoprost Ophthalmic Solution 0.005% | Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint) | 18.5 mmHg | Standard Error 0.27 |