Open-angle Glaucoma, Ocular Hypertension
Conditions
Keywords
Glaucoma
Brief summary
Treatment of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss. This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of four (4) concentrations of DE-126, when compared with latanoprost (0.005%) eye drops in patients with primary open-angle glaucoma or ocular hypertension. The IOP will be measured at 3 different times throughout the day, over 6 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, vital signs, and clinical laboratory tests. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.
Interventions
DRUGVehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution
Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
DRUGTopical ultra-low dose of DE-126 Ophthalmic Solution
Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
DRUGTopical low dose of DE-126 Ophthalmic Solution
Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
DRUGTopical medium dose of DE-126 Ophthalmic Solution
Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
DRUGTopical high dose of DE-126 Ophthalmic Solution
Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
DRUG0.005% Latanoprost Ophthalmic Solution
0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
Sponsors
Santen Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Qualifying Anterior chamber angle
Exclusion criteria
* History of ocular surgery specifically intended to lower IOP * Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period * 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 90 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 |
|---|---|---|
| Intraocular Pressure in the Study Eye at Month 3 | 9:00, 13:00 and 17:00 at Month 3 | Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 1, Week 2, Week 6 and Month 3. | Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject. |
| Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 1, Week 2, Week 6 and Month 3. | Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject. |
| Intraocular Pressure in the Study Eye at Week 1 and Week 2 | 9:00, 13:00 and 17:00 at Week 1 and Week 2 | Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. |
| Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 1, Week 2, Week 6 and Month 3. | Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject. |
| Intraocular Pressure in the Study Eye at Week 6 | 9:00, 13:00 and 17:00 at Week 6 | Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. |
| Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3. | Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. |
| Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | WeeK 1, Week 2, Week 6 and Month 3. | A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 20%. A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 25%. A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 30%. |
| Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Week 1, Week 2, Week 6 and Month 3. | A subject was a responder if the mean diurnal IOP in the study eye was ≤ 18 mmHg. |
| Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3. | Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. |
Countries
Japan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks | 22 |
| 0.005% Latanoprost 0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks | 44 |
| Ultra-low Dose 0.0005% DE-126 Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks | 43 |
| Low Dose 0.001% DE-126 Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks | 43 |
| Medium Dose 0.002% DE-126 Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks | 44 |
| High Dose 0.003% DE-126 Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks | 45 |
| Total | 241 |
Baseline characteristics
| Characteristic | Total | 0.005% Latanoprost | Ultra-low Dose 0.0005% DE-126 | Low Dose 0.001% DE-126 | Medium Dose 0.002% DE-126 | Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | High Dose 0.003% DE-126 |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 11.22 | 64.4 years STANDARD_DEVIATION 9.8 | 65.5 years STANDARD_DEVIATION 13.3 | 63.7 years STANDARD_DEVIATION 9.41 | 61.0 years STANDARD_DEVIATION 11.84 | 63.2 years STANDARD_DEVIATION 11.24 | 63.8 years STANDARD_DEVIATION 11.84 |
| Race/Ethnicity, Customized Hispanic or Latino | 32 Participants | 5 Participants | 7 Participants | 7 Participants | 5 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 209 Participants | 39 Participants | 36 Participants | 36 Participants | 39 Participants | 20 Participants | 39 Participants |
| Region of Enrollment Japan | 114 participants | 21 participants | 20 participants | 20 participants | 21 participants | 11 participants | 21 participants |
| Region of Enrollment United States | 127 participants | 23 participants | 23 participants | 23 participants | 23 participants | 11 participants | 24 participants |
| Sex: Female, Male Female | 135 Participants | 24 Participants | 26 Participants | 22 Participants | 25 Participants | 13 Participants | 25 Participants |
| Sex: Female, Male Male | 106 Participants | 20 Participants | 17 Participants | 21 Participants | 19 Participants | 9 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 20 | 0 / 44 | 0 / 43 | 0 / 43 | 0 / 44 | 0 / 45 | 0 / 65 | 0 / 195 |
| other Total, other adverse events | 2 / 22 | 10 / 20 | 18 / 44 | 13 / 43 | 12 / 43 | 10 / 44 | 12 / 45 | 22 / 65 | 57 / 195 |
| serious Total, serious adverse events | 1 / 22 | 0 / 20 | 0 / 44 | 0 / 43 | 0 / 43 | 0 / 44 | 0 / 45 | 0 / 65 | 0 / 195 |
Outcome results
Primary
Intraocular Pressure in the Study Eye at Month 3
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Time frame: 9:00, 13:00 and 17:00 at Month 3
Population: The number of participants is reduced due to missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Intraocular Pressure in the Study Eye at Month 3 | 13:00 | 17.6 mmHg | Standard Deviation 3.18 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Intraocular Pressure in the Study Eye at Month 3 | 9:00 | 18.8 mmHg | Standard Deviation 4.11 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Intraocular Pressure in the Study Eye at Month 3 | 17:00 | 17.8 mmHg | Standard Deviation 2.87 |
| 0.005% Latanoprost | Intraocular Pressure in the Study Eye at Month 3 | 13:00 | 17.3 mmHg | Standard Deviation 3.01 |
| 0.005% Latanoprost | Intraocular Pressure in the Study Eye at Month 3 | 9:00 | 18.1 mmHg | Standard Deviation 3.73 |
| 0.005% Latanoprost | Intraocular Pressure in the Study Eye at Month 3 | 17:00 | 17.2 mmHg | Standard Deviation 3.1 |
| Ultra-low Dose 0.0005% DE-126 | Intraocular Pressure in the Study Eye at Month 3 | 13:00 | 18.5 mmHg | Standard Deviation 2.98 |
| Ultra-low Dose 0.0005% DE-126 | Intraocular Pressure in the Study Eye at Month 3 | 9:00 | 19.7 mmHg | Standard Deviation 3.27 |
| Ultra-low Dose 0.0005% DE-126 | Intraocular Pressure in the Study Eye at Month 3 | 17:00 | 18.3 mmHg | Standard Deviation 2.55 |
| Low Dose 0.001% DE-126 | Intraocular Pressure in the Study Eye at Month 3 | 13:00 | 18.1 mmHg | Standard Deviation 2.99 |
| Low Dose 0.001% DE-126 | Intraocular Pressure in the Study Eye at Month 3 | 9:00 | 19.2 mmHg | Standard Deviation 3.37 |
| Low Dose 0.001% DE-126 | Intraocular Pressure in the Study Eye at Month 3 | 17:00 | 17.8 mmHg | Standard Deviation 2.93 |
| Medium Dose 0.002% DE-126 | Intraocular Pressure in the Study Eye at Month 3 | 13:00 | 17.4 mmHg | Standard Deviation 2.39 |
| Medium Dose 0.002% DE-126 | Intraocular Pressure in the Study Eye at Month 3 | 9:00 | 17.6 mmHg | Standard Deviation 3.13 |
| Medium Dose 0.002% DE-126 | Intraocular Pressure in the Study Eye at Month 3 | 17:00 | 16.7 mmHg | Standard Deviation 2.74 |
| High Dose 0.003% DE-126 | Intraocular Pressure in the Study Eye at Month 3 | 9:00 | 19.3 mmHg | Standard Deviation 2.92 |
| High Dose 0.003% DE-126 | Intraocular Pressure in the Study Eye at Month 3 | 17:00 | 17.9 mmHg | Standard Deviation 2.82 |
| High Dose 0.003% DE-126 | Intraocular Pressure in the Study Eye at Month 3 | 13:00 | 18.7 mmHg | Standard Deviation 3.17 |
Secondary
Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Time frame: 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.
Population: The number of participants is reduced due to missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 9:00 | -2.0 mmHg | Standard Deviation 2.59 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 9:00 | -2.1 mmHg | Standard Deviation 2.68 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 13:00 | -2.1 mmHg | Standard Deviation 2.66 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 17:00 | -6.1 mmHg | Standard Deviation 2.74 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 17:00 | -2.8 mmHg | Standard Deviation 2.81 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 13:00 | -6.0 mmHg | Standard Deviation 3.28 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 9:00 | -1.9 mmHg | Standard Deviation 2.66 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 13:00 | -1.8 mmHg | Standard Deviation 2.89 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 9:00 | -5.6 mmHg | Standard Deviation 3.21 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 17:00 | -2.4 mmHg | Standard Deviation 2.57 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 13:00 | -1.2 mmHg | Standard Deviation 2.73 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 17:00 | -2.7 mmHg | Standard Deviation 3.33 |
| 0.005% Latanoprost | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 13:00 | -6.9 mmHg | Standard Deviation 3.25 |
| 0.005% Latanoprost | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 17:00 | -6.2 mmHg | Standard Deviation 3.33 |
| 0.005% Latanoprost | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 9:00 | -7.3 mmHg | Standard Deviation 3.65 |
| 0.005% Latanoprost | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 17:00 | -6.8 mmHg | Standard Deviation 3.38 |
| 0.005% Latanoprost | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 9:00 | -7.4 mmHg | Standard Deviation 4.03 |
| 0.005% Latanoprost | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 9:00 | -6.9 mmHg | Standard Deviation 3.84 |
| 0.005% Latanoprost | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 17:00 | -6.7 mmHg | Standard Deviation 3.39 |
| 0.005% Latanoprost | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 9:00 | -7.0 mmHg | Standard Deviation 3.84 |
| 0.005% Latanoprost | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 13:00 | -6.8 mmHg | Standard Deviation 3.35 |
| 0.005% Latanoprost | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 13:00 | -6.8 mmHg | Standard Deviation 3.02 |
| 0.005% Latanoprost | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 13:00 | -7.0 mmHg | Standard Deviation 3.3 |
| 0.005% Latanoprost | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 17:00 | -6.4 mmHg | Standard Deviation 3.63 |
| Ultra-low Dose 0.0005% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 13:00 | -6.2 mmHg | Standard Deviation 3.36 |
| Ultra-low Dose 0.0005% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 17:00 | -5.7 mmHg | Standard Deviation 3.36 |
| Ultra-low Dose 0.0005% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 9:00 | -5.3 mmHg | Standard Deviation 2.65 |
| Ultra-low Dose 0.0005% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 17:00 | -5.6 mmHg | Standard Deviation 2.83 |
| Ultra-low Dose 0.0005% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 9:00 | -5.7 mmHg | Standard Deviation 3.03 |
| Ultra-low Dose 0.0005% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 17:00 | -5.9 mmHg | Standard Deviation 2.56 |
| Ultra-low Dose 0.0005% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 9:00 | -5.1 mmHg | Standard Deviation 2.42 |
| Ultra-low Dose 0.0005% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 13:00 | -5.9 mmHg | Standard Deviation 2.49 |
| Ultra-low Dose 0.0005% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 13:00 | -5.7 mmHg | Standard Deviation 2.73 |
| Ultra-low Dose 0.0005% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 9:00 | -5.5 mmHg | Standard Deviation 3.52 |
| Ultra-low Dose 0.0005% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 17:00 | -5.4 mmHg | Standard Deviation 2.74 |
| Ultra-low Dose 0.0005% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 13:00 | -6.1 mmHg | Standard Deviation 3.65 |
| Low Dose 0.001% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 13:00 | -6.2 mmHg | Standard Deviation 2.64 |
| Low Dose 0.001% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 9:00 | -6.0 mmHg | Standard Deviation 3.1 |
| Low Dose 0.001% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 13:00 | -5.6 mmHg | Standard Deviation 3.26 |
| Low Dose 0.001% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 17:00 | -5.2 mmHg | Standard Deviation 3.62 |
| Low Dose 0.001% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 9:00 | -6.2 mmHg | Standard Deviation 3 |
| Low Dose 0.001% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 13:00 | -6.0 mmHg | Standard Deviation 2.62 |
| Low Dose 0.001% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 17:00 | -5.8 mmHg | Standard Deviation 2.52 |
| Low Dose 0.001% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 9:00 | -6.4 mmHg | Standard Deviation 2.83 |
| Low Dose 0.001% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 17:00 | -5.7 mmHg | Standard Deviation 3.3 |
| Low Dose 0.001% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 9:00 | -5.7 mmHg | Standard Deviation 3.08 |
| Low Dose 0.001% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 13:00 | -6.0 mmHg | Standard Deviation 2.97 |
| Low Dose 0.001% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 17:00 | -5.8 mmHg | Standard Deviation 3.12 |
| Medium Dose 0.002% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 17:00 | -6.7 mmHg | Standard Deviation 3.6 |
| Medium Dose 0.002% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 9:00 | -6.7 mmHg | Standard Deviation 3.7 |
| Medium Dose 0.002% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 13:00 | -6.8 mmHg | Standard Deviation 3.59 |
| Medium Dose 0.002% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 17:00 | -6.9 mmHg | Standard Deviation 3.48 |
| Medium Dose 0.002% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 13:00 | -6.7 mmHg | Standard Deviation 3.34 |
| Medium Dose 0.002% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 17:00 | -7.0 mmHg | Standard Deviation 3.36 |
| Medium Dose 0.002% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 9:00 | -6.9 mmHg | Standard Deviation 3.32 |
| Medium Dose 0.002% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 17:00 | -6.9 mmHg | Standard Deviation 3.29 |
| Medium Dose 0.002% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 9:00 | -7.2 mmHg | Standard Deviation 3.32 |
| Medium Dose 0.002% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 9:00 | -6.1 mmHg | Standard Deviation 3.21 |
| Medium Dose 0.002% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 13:00 | -6.8 mmHg | Standard Deviation 3.67 |
| Medium Dose 0.002% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 13:00 | -6.8 mmHg | Standard Deviation 3.27 |
| High Dose 0.003% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 13:00 | -6.8 mmHg | Standard Deviation 3.11 |
| High Dose 0.003% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 13:00 | -6.7 mmHg | Standard Deviation 3.22 |
| High Dose 0.003% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 17:00 | -6.2 mmHg | Standard Deviation 3.16 |
| High Dose 0.003% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 9:00 | -6.4 mmHg | Standard Deviation 3.66 |
| High Dose 0.003% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 17:00 | -6.4 mmHg | Standard Deviation 2.98 |
| High Dose 0.003% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 17:00 | -5.5 mmHg | Standard Deviation 2.93 |
| High Dose 0.003% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 9:00 | -5.4 mmHg | Standard Deviation 3.41 |
| High Dose 0.003% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 13:00 | -6.7 mmHg | Standard Deviation 3.63 |
| High Dose 0.003% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 13:00 | -5.5 mmHg | Standard Deviation 3.53 |
| High Dose 0.003% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 9:00 | -6.6 mmHg | Standard Deviation 3.24 |
| High Dose 0.003% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 9:00 | -6.1 mmHg | Standard Deviation 3.55 |
| High Dose 0.003% DE-126 | Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 17:00 | -6.3 mmHg | Standard Deviation 3.15 |
Secondary
Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.
Time frame: Week 1, Week 2, Week 6 and Month 3.
Population: The number of participants is reduced due to missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 2 | -2.0 mmHg | Standard Deviation 2.15 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 1 | -2.1 mmHg | Standard Deviation 2.13 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Month 3 | -5.9 mmHg | Standard Deviation 2.65 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 6 | -2.3 mmHg | Standard Deviation 2.49 |
| 0.005% Latanoprost | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 1 | -6.7 mmHg | Standard Deviation 2.98 |
| 0.005% Latanoprost | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Month 3 | -6.7 mmHg | Standard Deviation 3.24 |
| 0.005% Latanoprost | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 2 | -7.0 mmHg | Standard Deviation 3.13 |
| 0.005% Latanoprost | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 6 | -7.0 mmHg | Standard Deviation 3.09 |
| Ultra-low Dose 0.0005% DE-126 | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 6 | -5.9 mmHg | Standard Deviation 2.73 |
| Ultra-low Dose 0.0005% DE-126 | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 2 | -5.8 mmHg | Standard Deviation 3.02 |
| Ultra-low Dose 0.0005% DE-126 | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Month 3 | -5.5 mmHg | Standard Deviation 2.11 |
| Ultra-low Dose 0.0005% DE-126 | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 1 | -5.5 mmHg | Standard Deviation 2.41 |
| Low Dose 0.001% DE-126 | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 1 | -5.6 mmHg | Standard Deviation 2.84 |
| Low Dose 0.001% DE-126 | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 6 | -6.1 mmHg | Standard Deviation 2.59 |
| Low Dose 0.001% DE-126 | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 2 | -6.0 mmHg | Standard Deviation 2.35 |
| Low Dose 0.001% DE-126 | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Month 3 | -5.9 mmHg | Standard Deviation 2.71 |
| Medium Dose 0.002% DE-126 | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 2 | -6.9 mmHg | Standard Deviation 2.87 |
| Medium Dose 0.002% DE-126 | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 1 | -6.7 mmHg | Standard Deviation 3.19 |
| Medium Dose 0.002% DE-126 | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 6 | -6.6 mmHg | Standard Deviation 3.08 |
| Medium Dose 0.002% DE-126 | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Month 3 | -6.9 mmHg | Standard Deviation 2.96 |
| High Dose 0.003% DE-126 | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 2 | -6.5 mmHg | Standard Deviation 2.94 |
| High Dose 0.003% DE-126 | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 1 | -6.6 mmHg | Standard Deviation 2.92 |
| High Dose 0.003% DE-126 | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Month 3 | -5.5 mmHg | Standard Deviation 2.67 |
| High Dose 0.003% DE-126 | Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 6 | -6.4 mmHg | Standard Deviation 2.68 |
Secondary
Intraocular Pressure in the Study Eye at Week 1 and Week 2
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Time frame: 9:00, 13:00 and 17:00 at Week 1 and Week 2
Population: The number of participants is reduced due to missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week1 9:00 | 22.8 mmHg | Standard Deviation 3.99 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week1 13:00 | 22.8 mmHg | Standard Deviation 3.66 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week1 17:00 | 21.6 mmHg | Standard Deviation 3.94 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week 2 9:00 | 22.7 mmHg | Standard Deviation 3.7 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week 2 13:00 | 22.0 mmHg | Standard Deviation 3.13 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week2 17:00 | 21.9 mmHg | Standard Deviation 3.93 |
| 0.005% Latanoprost | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week1 13:00 | 17.5 mmHg | Standard Deviation 2.25 |
| 0.005% Latanoprost | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week 2 9:00 | 17.6 mmHg | Standard Deviation 3.33 |
| 0.005% Latanoprost | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week2 17:00 | 16.9 mmHg | Standard Deviation 2.49 |
| 0.005% Latanoprost | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week1 9:00 | 17.7 mmHg | Standard Deviation 2.67 |
| 0.005% Latanoprost | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week1 17:00 | 17.4 mmHg | Standard Deviation 2.43 |
| 0.005% Latanoprost | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week 2 13:00 | 17.4 mmHg | Standard Deviation 2.45 |
| Ultra-low Dose 0.0005% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week2 17:00 | 18.2 mmHg | Standard Deviation 2.94 |
| Ultra-low Dose 0.0005% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week 2 13:00 | 18.2 mmHg | Standard Deviation 2.93 |
| Ultra-low Dose 0.0005% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week 2 9:00 | 19.4 mmHg | Standard Deviation 3.62 |
| Ultra-low Dose 0.0005% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week1 17:00 | 18.1 mmHg | Standard Deviation 2.94 |
| Ultra-low Dose 0.0005% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week1 9:00 | 19.4 mmHg | Standard Deviation 3.32 |
| Ultra-low Dose 0.0005% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week1 13:00 | 18.7 mmHg | Standard Deviation 3.28 |
| Low Dose 0.001% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week 2 9:00 | 18.7 mmHg | Standard Deviation 2.73 |
| Low Dose 0.001% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week1 13:00 | 18.6 mmHg | Standard Deviation 3.29 |
| Low Dose 0.001% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week1 17:00 | 18.5 mmHg | Standard Deviation 3.23 |
| Low Dose 0.001% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week2 17:00 | 17.8 mmHg | Standard Deviation 2.33 |
| Low Dose 0.001% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week 2 13:00 | 18.1 mmHg | Standard Deviation 2.77 |
| Low Dose 0.001% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week1 9:00 | 18.9 mmHg | Standard Deviation 2.82 |
| Medium Dose 0.002% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week1 9:00 | 18.1 mmHg | Standard Deviation 2.99 |
| Medium Dose 0.002% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week 2 13:00 | 17.2 mmHg | Standard Deviation 2.57 |
| Medium Dose 0.002% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week1 13:00 | 17.1 mmHg | Standard Deviation 2.65 |
| Medium Dose 0.002% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week1 17:00 | 16.9 mmHg | Standard Deviation 2.96 |
| Medium Dose 0.002% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week 2 9:00 | 17.9 mmHg | Standard Deviation 3.11 |
| Medium Dose 0.002% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week2 17:00 | 16.7 mmHg | Standard Deviation 2.89 |
| High Dose 0.003% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week 2 9:00 | 18.3 mmHg | Standard Deviation 3.13 |
| High Dose 0.003% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week1 17:00 | 17.2 mmHg | Standard Deviation 2.53 |
| High Dose 0.003% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week 2 13:00 | 17.6 mmHg | Standard Deviation 2.8 |
| High Dose 0.003% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week2 17:00 | 17.3 mmHg | Standard Deviation 2.59 |
| High Dose 0.003% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week1 13:00 | 17.6 mmHg | Standard Deviation 3.08 |
| High Dose 0.003% DE-126 | Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Week1 9:00 | 18.0 mmHg | Standard Deviation 2.66 |
Secondary
Intraocular Pressure in the Study Eye at Week 6
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Time frame: 9:00, 13:00 and 17:00 at Week 6
Population: The number of participants is reduced due to missing data. This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Intraocular Pressure in the Study Eye at Week 6 | 9:00 | 23.2 mmHg | Standard Error 0.66 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Intraocular Pressure in the Study Eye at Week 6 | 17:00 | 21.6 mmHg | Standard Error 0.62 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Intraocular Pressure in the Study Eye at Week 6 | 13:00 | 22.2 mmHg | Standard Error 0.61 |
| 0.005% Latanoprost | Intraocular Pressure in the Study Eye at Week 6 | 13:00 | 18.2 mmHg | Standard Error 0.42 |
| 0.005% Latanoprost | Intraocular Pressure in the Study Eye at Week 6 | 9:00 | 19.0 mmHg | Standard Error 0.46 |
| 0.005% Latanoprost | Intraocular Pressure in the Study Eye at Week 6 | 17:00 | 17.8 mmHg | Standard Error 0.43 |
| Ultra-low Dose 0.0005% DE-126 | Intraocular Pressure in the Study Eye at Week 6 | 13:00 | 17.9 mmHg | Standard Error 0.42 |
| Ultra-low Dose 0.0005% DE-126 | Intraocular Pressure in the Study Eye at Week 6 | 9:00 | 18.5 mmHg | Standard Error 0.46 |
| Ultra-low Dose 0.0005% DE-126 | Intraocular Pressure in the Study Eye at Week 6 | 17:00 | 17.9 mmHg | Standard Error 0.43 |
| Low Dose 0.001% DE-126 | Intraocular Pressure in the Study Eye at Week 6 | 9:00 | 18.7 mmHg | Standard Error 0.45 |
| Low Dose 0.001% DE-126 | Intraocular Pressure in the Study Eye at Week 6 | 17:00 | 16.6 mmHg | Standard Error 0.42 |
| Low Dose 0.001% DE-126 | Intraocular Pressure in the Study Eye at Week 6 | 13:00 | 17.3 mmHg | Standard Error 0.42 |
| Medium Dose 0.002% DE-126 | Intraocular Pressure in the Study Eye at Week 6 | 13:00 | 17.5 mmHg | Standard Error 0.41 |
| Medium Dose 0.002% DE-126 | Intraocular Pressure in the Study Eye at Week 6 | 9:00 | 18.7 mmHg | Standard Error 0.45 |
| Medium Dose 0.002% DE-126 | Intraocular Pressure in the Study Eye at Week 6 | 17:00 | 17.4 mmHg | Standard Error 0.42 |
Comparison: This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.p-value: <0.0001t-test, 2 sided
Comparison: This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.p-value: <0.0001t-test, 2 sided
Comparison: This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.p-value: <0.0001t-test, 2 sided
Comparison: This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.p-value: <0.0001t-test, 2 sided
Secondary
Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.
Time frame: Week 1, Week 2, Week 6 and Month 3.
Population: The number of participants is reduced due to missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 1 | 22.4 mmHg | Standard Deviation 3.48 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 2 | 22.2 mmHg | Standard Deviation 3.33 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 6 | 21.7 mmHg | Standard Deviation 2.9 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Month 3 | 18.1 mmHg | Standard Deviation 3.14 |
| 0.005% Latanoprost | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 6 | 17.3 mmHg | Standard Deviation 2.8 |
| 0.005% Latanoprost | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 2 | 17.3 mmHg | Standard Deviation 2.51 |
| 0.005% Latanoprost | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 1 | 17.5 mmHg | Standard Deviation 2.12 |
| 0.005% Latanoprost | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Month 3 | 17.5 mmHg | Standard Deviation 2.98 |
| Ultra-low Dose 0.0005% DE-126 | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Month 3 | 18.8 mmHg | Standard Deviation 2.66 |
| Ultra-low Dose 0.0005% DE-126 | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 6 | 18.4 mmHg | Standard Deviation 2.4 |
| Ultra-low Dose 0.0005% DE-126 | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 2 | 18.6 mmHg | Standard Deviation 2.92 |
| Ultra-low Dose 0.0005% DE-126 | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 1 | 18.8 mmHg | Standard Deviation 2.95 |
| Low Dose 0.001% DE-126 | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 1 | 18.7 mmHg | Standard Deviation 2.88 |
| Low Dose 0.001% DE-126 | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Month 3 | 18.4 mmHg | Standard Deviation 2.94 |
| Low Dose 0.001% DE-126 | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 2 | 18.2 mmHg | Standard Deviation 2.37 |
| Low Dose 0.001% DE-126 | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 6 | 18.1 mmHg | Standard Deviation 2.5 |
| Medium Dose 0.002% DE-126 | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 6 | 17.5 mmHg | Standard Deviation 2.69 |
| Medium Dose 0.002% DE-126 | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Month 3 | 17.2 mmHg | Standard Deviation 2.47 |
| Medium Dose 0.002% DE-126 | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 2 | 17.3 mmHg | Standard Deviation 2.58 |
| Medium Dose 0.002% DE-126 | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 1 | 17.4 mmHg | Standard Deviation 2.64 |
| High Dose 0.003% DE-126 | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 2 | 17.7 mmHg | Standard Deviation 2.52 |
| High Dose 0.003% DE-126 | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 6 | 17.8 mmHg | Standard Deviation 2.69 |
| High Dose 0.003% DE-126 | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Month 3 | 18.6 mmHg | Standard Deviation 2.71 |
| High Dose 0.003% DE-126 | Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 1 | 17.6 mmHg | Standard Deviation 2.59 |
Secondary
Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit
A subject was a responder if the mean diurnal IOP in the study eye was ≤ 18 mmHg.
Time frame: Week 1, Week 2, Week 6 and Month 3.
Population: The number of participants is reduced due to missing data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Week 6 -Reduced to 18 mmHg or Lower | 2 Participants |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Week 1 -Reduced to 18 mmHg or Lower | 0 Participants |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Week 2 -Reduced to 18 mmHg or Lower | 1 Participants |
| 0.005% Latanoprost | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Week 1 -Reduced to 18 mmHg or Lower | 29 Participants |
| 0.005% Latanoprost | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Month 3 -Reduced to 18 mmHg or Lower | 30 Participants |
| 0.005% Latanoprost | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Week 6 -Reduced to 18 mmHg or Lower | 27 Participants |
| 0.005% Latanoprost | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Week 2 -Reduced to 18 mmHg or Lower | 30 Participants |
| Ultra-low Dose 0.0005% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Week 6 -Reduced to 18 mmHg or Lower | 24 Participants |
| Ultra-low Dose 0.0005% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Month 3 -Reduced to 18 mmHg or Lower | 18 Participants |
| Ultra-low Dose 0.0005% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Week 2 -Reduced to 18 mmHg or Lower | 18 Participants |
| Ultra-low Dose 0.0005% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Week 1 -Reduced to 18 mmHg or Lower | 16 Participants |
| Low Dose 0.001% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Month 3 -Reduced to 18 mmHg or Lower | 19 Participants |
| Low Dose 0.001% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Week 2 -Reduced to 18 mmHg or Lower | 22 Participants |
| Low Dose 0.001% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Week 1 -Reduced to 18 mmHg or Lower | 20 Participants |
| Low Dose 0.001% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Week 6 -Reduced to 18 mmHg or Lower | 22 Participants |
| Medium Dose 0.002% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Month 3 -Reduced to 18 mmHg or Lower | 27 Participants |
| Medium Dose 0.002% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Week 1 -Reduced to 18 mmHg or Lower | 26 Participants |
| Medium Dose 0.002% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Week 2 -Reduced to 18 mmHg or Lower | 27 Participants |
| Medium Dose 0.002% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Week 6 -Reduced to 18 mmHg or Lower | 25 Participants |
| High Dose 0.003% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Week 6 -Reduced to 18 mmHg or Lower | 23 Participants |
| High Dose 0.003% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Month 3 -Reduced to 18 mmHg or Lower | 14 Participants |
| High Dose 0.003% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Week 2 -Reduced to 18 mmHg or Lower | 23 Participants |
| High Dose 0.003% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | Week 1 -Reduced to 18 mmHg or Lower | 30 Participants |
Secondary
Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit
A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 20%. A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 25%. A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 30%.
Time frame: WeeK 1, Week 2, Week 6 and Month 3.
Population: The number of participants is reduced due to missing data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 1- At Least 30% Reduction | 0 Participants |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 2- At Least 30% Reduction | 0 Participants |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 1- At Least 20% Reduction | 2 Participants |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 6- At Least 25% Reduction | 1 Participants |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 2- At Least 25% Reduction | 0 Participants |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 6- At Least 20% Reduction | 3 Participants |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 2- At Least 20% Reduction | 0 Participants |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 6- At Least 30% Reduction | 1 Participants |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 1- At Least 25% Reduction | 0 Participants |
| 0.005% Latanoprost | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 6- At Least 20% Reduction | 37 Participants |
| 0.005% Latanoprost | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 2- At Least 20% Reduction | 38 Participants |
| 0.005% Latanoprost | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 2- At Least 30% Reduction | 20 Participants |
| 0.005% Latanoprost | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Month 3- At Least 30% Reduction | 16 Participants |
| 0.005% Latanoprost | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 2- At Least 25% Reduction | 27 Participants |
| 0.005% Latanoprost | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Month 3- At Least 25% Reduction | 23 Participants |
| 0.005% Latanoprost | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Month 3- At Least 20% Reduction | 36 Participants |
| 0.005% Latanoprost | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 1- At Least 25% Reduction | 23 Participants |
| 0.005% Latanoprost | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 6- At Least 30% Reduction | 19 Participants |
| 0.005% Latanoprost | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 6- At Least 25% Reduction | 26 Participants |
| 0.005% Latanoprost | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 1- At Least 30% Reduction | 16 Participants |
| 0.005% Latanoprost | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 1- At Least 20% Reduction | 36 Participants |
| Ultra-low Dose 0.0005% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 1- At Least 25% Reduction | 18 Participants |
| Ultra-low Dose 0.0005% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 1- At Least 20% Reduction | 22 Participants |
| Ultra-low Dose 0.0005% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 1- At Least 30% Reduction | 9 Participants |
| Ultra-low Dose 0.0005% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 2- At Least 20% Reduction | 27 Participants |
| Ultra-low Dose 0.0005% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 2- At Least 25% Reduction | 21 Participants |
| Ultra-low Dose 0.0005% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 2- At Least 30% Reduction | 13 Participants |
| Ultra-low Dose 0.0005% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 6- At Least 20% Reduction | 30 Participants |
| Ultra-low Dose 0.0005% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 6- At Least 25% Reduction | 17 Participants |
| Ultra-low Dose 0.0005% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 6- At Least 30% Reduction | 12 Participants |
| Ultra-low Dose 0.0005% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Month 3- At Least 20% Reduction | 28 Participants |
| Ultra-low Dose 0.0005% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Month 3- At Least 25% Reduction | 15 Participants |
| Ultra-low Dose 0.0005% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Month 3- At Least 30% Reduction | 7 Participants |
| Low Dose 0.001% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 2- At Least 30% Reduction | 13 Participants |
| Low Dose 0.001% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 6- At Least 20% Reduction | 28 Participants |
| Low Dose 0.001% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 1- At Least 30% Reduction | 8 Participants |
| Low Dose 0.001% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 1- At Least 20% Reduction | 28 Participants |
| Low Dose 0.001% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 6- At Least 25% Reduction | 22 Participants |
| Low Dose 0.001% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 1- At Least 25% Reduction | 15 Participants |
| Low Dose 0.001% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 6- At Least 30% Reduction | 18 Participants |
| Low Dose 0.001% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Month 3- At Least 30% Reduction | 11 Participants |
| Low Dose 0.001% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Month 3- At Least 20% Reduction | 27 Participants |
| Low Dose 0.001% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Month 3- At Least 25% Reduction | 22 Participants |
| Low Dose 0.001% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 2- At Least 25% Reduction | 22 Participants |
| Low Dose 0.001% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 2- At Least 20% Reduction | 26 Participants |
| Medium Dose 0.002% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Month 3- At Least 30% Reduction | 16 Participants |
| Medium Dose 0.002% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 6- At Least 25% Reduction | 22 Participants |
| Medium Dose 0.002% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 1- At Least 25% Reduction | 25 Participants |
| Medium Dose 0.002% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 2- At Least 20% Reduction | 31 Participants |
| Medium Dose 0.002% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Month 3- At Least 25% Reduction | 28 Participants |
| Medium Dose 0.002% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 6- At Least 30% Reduction | 15 Participants |
| Medium Dose 0.002% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 2- At Least 25% Reduction | 27 Participants |
| Medium Dose 0.002% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Month 3- At Least 20% Reduction | 37 Participants |
| Medium Dose 0.002% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 2- At Least 30% Reduction | 17 Participants |
| Medium Dose 0.002% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 1- At Least 30% Reduction | 14 Participants |
| Medium Dose 0.002% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 6- At Least 20% Reduction | 30 Participants |
| Medium Dose 0.002% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 1- At Least 20% Reduction | 31 Participants |
| High Dose 0.003% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 1- At Least 25% Reduction | 27 Participants |
| High Dose 0.003% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 6- At Least 20% Reduction | 28 Participants |
| High Dose 0.003% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 6- At Least 25% Reduction | 26 Participants |
| High Dose 0.003% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 2- At Least 30% Reduction | 15 Participants |
| High Dose 0.003% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 1- At Least 30% Reduction | 18 Participants |
| High Dose 0.003% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Month 3- At Least 30% Reduction | 10 Participants |
| High Dose 0.003% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 2- At Least 20% Reduction | 33 Participants |
| High Dose 0.003% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Month 3- At Least 25% Reduction | 18 Participants |
| High Dose 0.003% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 6- At Least 30% Reduction | 14 Participants |
| High Dose 0.003% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 1- At Least 20% Reduction | 34 Participants |
| High Dose 0.003% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Month 3- At Least 20% Reduction | 23 Participants |
| High Dose 0.003% DE-126 | Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | Week 2- At Least 25% Reduction | 24 Participants |
Secondary
Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Time frame: 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.
Population: The number of participants is reduced due to missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 17:00 | -11.1 Percentage of change in IOP | Standard Deviation 13.12 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 13:00 | -5.3 Percentage of change in IOP | Standard Deviation 10.75 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 13:00 | -8.6 Percentage of change in IOP | Standard Deviation 10.89 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 9:00 | -8.7 Percentage of change in IOP | Standard Deviation 9.58 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 17:00 | -25.4 Percentage of change in IOP | Standard Deviation 11.12 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 17:00 | -11.5 Percentage of change in IOP | Standard Deviation 10.56 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 13:00 | -25.3 Percentage of change in IOP | Standard Deviation 13.15 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 9:00 | -7.8 Percentage of change in IOP | Standard Deviation 10.3 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 13:00 | -7.5 Percentage of change in IOP | Standard Deviation 12.08 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 9:00 | -23.3 Percentage of change in IOP | Standard Deviation 13.33 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 17:00 | -9.9 Percentage of change in IOP | Standard Deviation 10.16 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 9:00 | -8.4 Percentage of change in IOP | Standard Deviation 10.71 |
| 0.005% Latanoprost | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 17:00 | -28.4 Percentage of change in IOP | Standard Deviation 12.62 |
| 0.005% Latanoprost | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 9:00 | -27.5 Percentage of change in IOP | Standard Deviation 12.44 |
| 0.005% Latanoprost | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 17:00 | -27.8 Percentage of change in IOP | Standard Deviation 12.69 |
| 0.005% Latanoprost | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 13:00 | -27.8 Percentage of change in IOP | Standard Deviation 10.89 |
| 0.005% Latanoprost | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 9:00 | -28.9 Percentage of change in IOP | Standard Deviation 13.13 |
| 0.005% Latanoprost | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 13:00 | -28.8 Percentage of change in IOP | Standard Deviation 12.25 |
| 0.005% Latanoprost | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 17:00 | -25.7 Percentage of change in IOP | Standard Deviation 12.62 |
| 0.005% Latanoprost | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 13:00 | -27.3 Percentage of change in IOP | Standard Deviation 11.41 |
| 0.005% Latanoprost | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 9:00 | -28.5 Percentage of change in IOP | Standard Deviation 12 |
| 0.005% Latanoprost | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 13:00 | -28.2 Percentage of change in IOP | Standard Deviation 12.3 |
| 0.005% Latanoprost | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 17:00 | -26.8 Percentage of change in IOP | Standard Deviation 14.63 |
| 0.005% Latanoprost | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 9:00 | -27.3 Percentage of change in IOP | Standard Deviation 13.11 |
| Ultra-low Dose 0.0005% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 13:00 | -24.2 Percentage of change in IOP | Standard Deviation 10 |
| Ultra-low Dose 0.0005% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 17:00 | -23.4 Percentage of change in IOP | Standard Deviation 10.96 |
| Ultra-low Dose 0.0005% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 9:00 | -21.7 Percentage of change in IOP | Standard Deviation 13.84 |
| Ultra-low Dose 0.0005% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 9:00 | -21.6 Percentage of change in IOP | Standard Deviation 10.44 |
| Ultra-low Dose 0.0005% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 9:00 | -20.6 Percentage of change in IOP | Standard Deviation 9.64 |
| Ultra-low Dose 0.0005% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 17:00 | -23.5 Percentage of change in IOP | Standard Deviation 12.42 |
| Ultra-low Dose 0.0005% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 9:00 | -22.8 Percentage of change in IOP | Standard Deviation 10.71 |
| Ultra-low Dose 0.0005% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 13:00 | -24.5 Percentage of change in IOP | Standard Deviation 12.69 |
| Ultra-low Dose 0.0005% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 13:00 | -25.1 Percentage of change in IOP | Standard Deviation 12.42 |
| Ultra-low Dose 0.0005% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 13:00 | -23.3 Percentage of change in IOP | Standard Deviation 11.09 |
| Ultra-low Dose 0.0005% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 17:00 | -22.7 Percentage of change in IOP | Standard Deviation 10.37 |
| Ultra-low Dose 0.0005% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 17:00 | -24.6 Percentage of change in IOP | Standard Deviation 9.63 |
| Low Dose 0.001% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 13:00 | -22.8 Percentage of change in IOP | Standard Deviation 12.54 |
| Low Dose 0.001% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 9:00 | -23.7 Percentage of change in IOP | Standard Deviation 11.01 |
| Low Dose 0.001% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 17:00 | -21.5 Percentage of change in IOP | Standard Deviation 14.33 |
| Low Dose 0.001% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 9:00 | -24.5 Percentage of change in IOP | Standard Deviation 10.62 |
| Low Dose 0.001% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 13:00 | -24.9 Percentage of change in IOP | Standard Deviation 10.09 |
| Low Dose 0.001% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 17:00 | -24.4 Percentage of change in IOP | Standard Deviation 9.53 |
| Low Dose 0.001% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 9:00 | -25.3 Percentage of change in IOP | Standard Deviation 9.93 |
| Low Dose 0.001% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 13:00 | -25.6 Percentage of change in IOP | Standard Deviation 9.85 |
| Low Dose 0.001% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 17:00 | -24.0 Percentage of change in IOP | Standard Deviation 12.84 |
| Low Dose 0.001% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 9:00 | -22.8 Percentage of change in IOP | Standard Deviation 11.48 |
| Low Dose 0.001% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 13:00 | -24.8 Percentage of change in IOP | Standard Deviation 11.33 |
| Low Dose 0.001% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 17:00 | -24.3 Percentage of change in IOP | Standard Deviation 12.06 |
| Medium Dose 0.002% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 13:00 | -27.8 Percentage of change in IOP | Standard Deviation 11.83 |
| Medium Dose 0.002% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 17:00 | -27.9 Percentage of change in IOP | Standard Deviation 13.1 |
| Medium Dose 0.002% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 9:00 | -26.5 Percentage of change in IOP | Standard Deviation 12.64 |
| Medium Dose 0.002% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 17:00 | -28.7 Percentage of change in IOP | Standard Deviation 12.82 |
| Medium Dose 0.002% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 13:00 | -27.3 Percentage of change in IOP | Standard Deviation 11.73 |
| Medium Dose 0.002% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 9:00 | -27.4 Percentage of change in IOP | Standard Deviation 11.69 |
| Medium Dose 0.002% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 13:00 | -28.0 Percentage of change in IOP | Standard Deviation 12.43 |
| Medium Dose 0.002% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 17:00 | -29.4 Percentage of change in IOP | Standard Deviation 11.86 |
| Medium Dose 0.002% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 9:00 | -24.4 Percentage of change in IOP | Standard Deviation 11.45 |
| Medium Dose 0.002% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 9:00 | -28.8 Percentage of change in IOP | Standard Deviation 11.66 |
| Medium Dose 0.002% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 13:00 | -27.7 Percentage of change in IOP | Standard Deviation 12.16 |
| Medium Dose 0.002% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 17:00 | -28.8 Percentage of change in IOP | Standard Deviation 12.48 |
| High Dose 0.003% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 13:00 | -27.8 Percentage of change in IOP | Standard Deviation 11.27 |
| High Dose 0.003% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 13:00 | -27.0 Percentage of change in IOP | Standard Deviation 11.93 |
| High Dose 0.003% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 17:00 | -26.1 Percentage of change in IOP | Standard Deviation 12.12 |
| High Dose 0.003% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 9:00 | -25.6 Percentage of change in IOP | Standard Deviation 13.56 |
| High Dose 0.003% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 17:00 | -23.4 Percentage of change in IOP | Standard Deviation 11.96 |
| High Dose 0.003% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 9:00 | -21.4 Percentage of change in IOP | Standard Deviation 12.63 |
| High Dose 0.003% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 17:00 | -26.8 Percentage of change in IOP | Standard Deviation 11.24 |
| High Dose 0.003% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 13:00 | -27.0 Percentage of change in IOP | Standard Deviation 13.5 |
| High Dose 0.003% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Month 3 at 13:00 | -22.5 Percentage of change in IOP | Standard Deviation 13.24 |
| High Dose 0.003% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 6 9:00 | -24.3 Percentage of change in IOP | Standard Deviation 13.78 |
| High Dose 0.003% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 1 9:00 | -26.5 Percentage of change in IOP | Standard Deviation 11.41 |
| High Dose 0.003% DE-126 | Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Week 2 17:00 | -26.3 Percentage of change in IOP | Standard Deviation 11.95 |
Secondary
Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.
Time frame: Week 1, Week 2, Week 6 and Month 3.
Population: The number of participants is reduced due to missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 1 | -8.6 Percentage of change | Standard Deviation 8.15 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 2 | -8.6 Percentage of change | Standard Deviation 8.74 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 6 | -9.4 Percentage of change | Standard Deviation 10.31 |
| Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Month 3 | -24.7 Percentage of change | Standard Deviation 11.26 |
| 0.005% Latanoprost | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 6 | -28.5 Percentage of change | Standard Deviation 11.23 |
| 0.005% Latanoprost | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 2 | -28.3 Percentage of change | Standard Deviation 11.05 |
| 0.005% Latanoprost | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 1 | -27.3 Percentage of change | Standard Deviation 10.6 |
| 0.005% Latanoprost | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Month 3 | -27.5 Percentage of change | Standard Deviation 12.11 |
| Ultra-low Dose 0.0005% DE-126 | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Month 3 | -22.6 Percentage of change | Standard Deviation 8.22 |
| Ultra-low Dose 0.0005% DE-126 | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 6 | -24.0 Percentage of change | Standard Deviation 9.58 |
| Ultra-low Dose 0.0005% DE-126 | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 2 | -23.5 Percentage of change | Standard Deviation 11.28 |
| Ultra-low Dose 0.0005% DE-126 | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 1 | -22.8 Percentage of change | Standard Deviation 9.59 |
| Low Dose 0.001% DE-126 | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 1 | -22.9 Percentage of change | Standard Deviation 10.78 |
| Low Dose 0.001% DE-126 | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Month 3 | -24.1 Percentage of change | Standard Deviation 10.45 |
| Low Dose 0.001% DE-126 | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 2 | -24.7 Percentage of change | Standard Deviation 8.9 |
| Low Dose 0.001% DE-126 | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 6 | -25.1 Percentage of change | Standard Deviation 9.83 |
| Medium Dose 0.002% DE-126 | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 6 | -27.2 Percentage of change | Standard Deviation 10.72 |
| Medium Dose 0.002% DE-126 | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Month 3 | -28.4 Percentage of change | Standard Deviation 10.54 |
| Medium Dose 0.002% DE-126 | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 2 | -28.2 Percentage of change | Standard Deviation 10.48 |
| Medium Dose 0.002% DE-126 | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 1 | -27.4 Percentage of change | Standard Deviation 11.48 |
| High Dose 0.003% DE-126 | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 2 | -26.4 Percentage of change | Standard Deviation 11.27 |
| High Dose 0.003% DE-126 | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 6 | -26.2 Percentage of change | Standard Deviation 10.51 |
| High Dose 0.003% DE-126 | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Month 3 | -22.7 Percentage of change | Standard Deviation 10.79 |
| High Dose 0.003% DE-126 | Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Week 1 | -27.0 Percentage of change | Standard Deviation 11.12 |