Primary Open-angle Glaucoma and Ocular Hypertension
Conditions
Brief summary
Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or OHT
Interventions
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
Sponsors
Santen Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Primary Open-Angle Glaucoma or Ocular Hypertension in one or both eyes. * Provide signed written informed consent. * Diagnosis of POAG or OHT in both eyes. * Qualifying corrected visual acuity in each eye. * Qualifying central corneal thickness in each eye. * Qualifying Day 1 IOP measurement at 3 time-points in both eyes after latanoprost Run-in Period. * Qualifying Anterior chamber angle. * Qualifying IOP measurement at 3 time-points during latanoprost Run-in Period.
Exclusion criteria
* Patients who cannot safely discontinue use of Ocular Hypotensive Medications during Washout. * Patients with prior exposure to DE-117. * History of ocular surgery specifically intended to lower IOP * Advanced glaucoma in either eye. * Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry. * Any ocular surgery or ocular laser treatment within 180 days prior to Visit 1 (Screening) and throughout the study in either eye. * Females who are pregnant, nursing, or planning a pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3. | Month 3 | IOP lowering effect of DE-117 ophthalmic solution 0.002% in Latanoprost low/non-responder subjects. Mean Diurnal Intraocular Pressure: Analysis of Change from Baseline in IOP score at Month 3 using Paired T-test on Observed Case. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8:00,12:00, 16:00) at Month 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6 | week 2 and 6 | Change from baseline (Visit 4) in mean diurnal IOP at Week 2 (Visit 5) and Week 6 (Visit 6). |
| Change From Baseline in IOP at Timepoints at Week 2 | 08:00, 12:00 and 16:00 at Week 2 | Change in mean IOP were evaluated at each time point at all post-baseline visits. (Change from baseline measurement at each timepoint was calculated by deducting the baseline value at corresponding timepoint from the IOP measurement). |
| Change From Baseline in IOP at Timepoints at Week 6 | 08:00, 12:00 and 16:00 at Week 6 | Change in mean IOP were evaluated at each time point at all post-baseline visits. |
| Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3 | week 2, 6 and month 3 | The secondary efficacy endpoint evaluated percent change from baseline in mean DIOP at week 2, 6 and month 3. |
| Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2 | 08:00, 12:00 and 16:00 at week 2 | Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint. |
| Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6 | 08:00, 12:00 and 16:00 at week 6 | Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint. |
| Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3 | 08:00, 12:00 and 16:00 at month 3. | Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint. |
| Change From Baseline in IOP at Timepoints at Month 3 | 08:00, 12:00 and 16:00 at month 3 | Change in mean IOP were evaluated at each time point at all post-baseline visits. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DE-117 Ophthalmic Solution 0.002% Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
DE-117 Ophthalmic Solution: Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period. | 107 |
| Total | 107 |
Baseline characteristics
| Characteristic | DE-117 Ophthalmic Solution 0.002% |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 54 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants |
| Age, Continuous | 63.1 years STANDARD_DEVIATION 10.17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 91 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 42 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 64 Participants |
| Region of Enrollment United States | 107 participants |
| Sex: Female, Male Female | 63 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 107 |
| other Total, other adverse events | 27 / 107 |
| serious Total, serious adverse events | 0 / 107 |
Outcome results
Primary
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3.
IOP lowering effect of DE-117 ophthalmic solution 0.002% in Latanoprost low/non-responder subjects. Mean Diurnal Intraocular Pressure: Analysis of Change from Baseline in IOP score at Month 3 using Paired T-test on Observed Case. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8:00,12:00, 16:00) at Month 3.
Time frame: Month 3
Population: Full Analysis Set (observed cases only)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DE-117 Ophthalmic Solution 0.002% | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3. | -2.96 mmHg | Standard Deviation 2.831 |
Secondary
Change From Baseline in IOP at Timepoints at Month 3
Change in mean IOP were evaluated at each time point at all post-baseline visits.
Time frame: 08:00, 12:00 and 16:00 at month 3
Population: Full Analysis Set (observed cases only).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DE-117 Ophthalmic Solution 0.002% | Change From Baseline in IOP at Timepoints at Month 3 | 8:00 | -2.76 mmHg | Standard Deviation 3.18 |
| DE-117 Ophthalmic Solution 0.002% | Change From Baseline in IOP at Timepoints at Month 3 | 12:00 | -2.98 mmHg | Standard Deviation 3.2 |
| DE-117 Ophthalmic Solution 0.002% | Change From Baseline in IOP at Timepoints at Month 3 | 16:00 | -3.08 mmHg | Standard Deviation 3.186 |
Secondary
Change From Baseline in IOP at Timepoints at Week 2
Change in mean IOP were evaluated at each time point at all post-baseline visits. (Change from baseline measurement at each timepoint was calculated by deducting the baseline value at corresponding timepoint from the IOP measurement).
Time frame: 08:00, 12:00 and 16:00 at Week 2
Population: Full Analysis Set (observed cases only).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DE-117 Ophthalmic Solution 0.002% | Change From Baseline in IOP at Timepoints at Week 2 | 8:00 | -2.52 mmHg | Standard Deviation 2.976 |
| DE-117 Ophthalmic Solution 0.002% | Change From Baseline in IOP at Timepoints at Week 2 | 12:00 | -2.94 mmHg | Standard Deviation 2.922 |
| DE-117 Ophthalmic Solution 0.002% | Change From Baseline in IOP at Timepoints at Week 2 | 16:00 | -3.15 mmHg | Standard Deviation 3.077 |
Secondary
Change From Baseline in IOP at Timepoints at Week 6
Change in mean IOP were evaluated at each time point at all post-baseline visits.
Time frame: 08:00, 12:00 and 16:00 at Week 6
Population: Full Analysis Set (observed cases only)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DE-117 Ophthalmic Solution 0.002% | Change From Baseline in IOP at Timepoints at Week 6 | 8:00 | -2.42 mmHg | Standard Deviation 3.209 |
| DE-117 Ophthalmic Solution 0.002% | Change From Baseline in IOP at Timepoints at Week 6 | 12:00 | -2.86 mmHg | Standard Deviation 2.832 |
| DE-117 Ophthalmic Solution 0.002% | Change From Baseline in IOP at Timepoints at Week 6 | 16:00 | -3.44 mmHg | Standard Deviation 3.127 |
Secondary
Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6
Change from baseline (Visit 4) in mean diurnal IOP at Week 2 (Visit 5) and Week 6 (Visit 6).
Time frame: week 2 and 6
Population: Full Analysis Set (observed cases only).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DE-117 Ophthalmic Solution 0.002% | Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6 | Week 2 | -2.87 mmHg | Standard Deviation 2.531 |
| DE-117 Ophthalmic Solution 0.002% | Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6 | Week 6 | -2.89 mmHg | Standard Deviation 2.578 |
Secondary
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3
Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
Time frame: 08:00, 12:00 and 16:00 at month 3.
Population: Full Analysis Set (observed cases only).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DE-117 Ophthalmic Solution 0.002% | Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3 | 8:00 | -11.43 Percent change | Standard Deviation 13.133 |
| DE-117 Ophthalmic Solution 0.002% | Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3 | 12:00 | -12.72 Percent change | Standard Deviation 13.467 |
| DE-117 Ophthalmic Solution 0.002% | Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3 | 16:00 | -13.13 Percent change | Standard Deviation 13.309 |
Secondary
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2
Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
Time frame: 08:00, 12:00 and 16:00 at week 2
Population: Full Analysis Set (observed cases only).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DE-117 Ophthalmic Solution 0.002% | Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2 | 8:00 | -10.42 Percent change | Standard Deviation 12.509 |
| DE-117 Ophthalmic Solution 0.002% | Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2 | 12:00 | -12.51 Percent change | Standard Deviation 12.765 |
| DE-117 Ophthalmic Solution 0.002% | Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2 | 16:00 | -13.47 Percent change | Standard Deviation 13.204 |
Secondary
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6
Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
Time frame: 08:00, 12:00 and 16:00 at week 6
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DE-117 Ophthalmic Solution 0.002% | Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6 | 8:00 | -10.04 Percent change | Standard Deviation 13.653 |
| DE-117 Ophthalmic Solution 0.002% | Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6 | 12:00 | -12.22 Percent change | Standard Deviation 12.432 |
| DE-117 Ophthalmic Solution 0.002% | Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6 | 16:00 | -14.80 Percent change | Standard Deviation 13.482 |
Secondary
Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3
The secondary efficacy endpoint evaluated percent change from baseline in mean DIOP at week 2, 6 and month 3.
Time frame: week 2, 6 and month 3
Population: Full Analysis Set (observed cases only).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DE-117 Ophthalmic Solution 0.002% | Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3 | Week 2 | -12.21 Percent change | Standard Deviation 10.855 |
| DE-117 Ophthalmic Solution 0.002% | Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3 | Week 6 | -12.40 Percent change | Standard Deviation 11.218 |
| DE-117 Ophthalmic Solution 0.002% | Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3 | Month 3 | -12.57 Percent change | Standard Deviation 11.907 |