Primary Open Angle Glaucoma, Ocular Hypertension
Conditions
Keywords
Glaucoma
Brief summary
Reduction 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 DE-126, ophthalmic solution in subjects with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The IOP will be measured at 3 different times throughout the day, over 4 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, and vital signs. 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
DRUGDE-126 Ophthalmic Solution 0.002% QD
DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning
Timolol Maleate Ophthalmic Solution BID (morning and evening)
Sponsors
Santen Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have been diagnosed of POAG or OHT in both eyes, or one eye with OAG and other with OHT * Completed the required wait/washout period * Qualifying Day 1 IOP measurement at 3 time-points in both eyes
Exclusion criteria
* Females who are pregnant, nursing, or planning a pregnancy * Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period. * History of ocular surgery specifically intended to lower IOP in either eye. Laser iridotomy in history is allowed * Presence of advanced glaucoma in either eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure at Week 2 | 08:00, 10:00 and 16:00 at Week 2 | Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM). |
| Intraocular Pressure at Week 6 | 08:00, 10:00 and 16:00 at Week 6 | Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM). |
| Intraocular Pressure at Month 3 | 08:00, 10:00 and 16:00 at Month 3 | Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Diurnal Intraocular Pressure at Month 3 | Three months | Mean diurnal Intraocular Pressure (IOP) was defined as the mean of the IOP valued at the three schedules timepoints (8:00, 10:00 and 16:00) at that visit for that subject. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Timolol Maleate Opthalmic Solution 0.5% BID Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID)
Timolol Maleate Ophthalmic Solution 0.5% BID: Timolol Maleate Ophthalmic Solution BID (morning and evening) | 161 |
| DE-126 Opthalmic Solution 0.002% QD and Vehicle QD DE-126 Ophthalmic Solution 0.002% is administered once daily (QD)
DE-126 Ophthalmic Solution 0.002% QD: DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning | 162 |
| Total | 323 |
Baseline characteristics
| Characteristic | Timolol Maleate Opthalmic Solution 0.5% BID | DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | Total |
|---|---|---|---|
| Age, Continuous | 65.5 years STANDARD_DEVIATION 11.63 | 66.2 years STANDARD_DEVIATION 10.24 | 65.9 years STANDARD_DEVIATION 10.95 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 43 Participants | 36 Participants | 79 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 116 Participants | 120 Participants | 236 Participants |
| Sex: Female, Male Female | 83 Participants | 86 Participants | 169 Participants |
| Sex: Female, Male Male | 78 Participants | 76 Participants | 154 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 160 | 0 / 161 |
| other Total, other adverse events | 34 / 160 | 38 / 161 |
| serious Total, serious adverse events | 3 / 160 | 1 / 161 |
Outcome results
Primary
Intraocular Pressure at Month 3
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Time frame: 08:00, 10:00 and 16:00 at Month 3
Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of the study medication (test or control medication) and had at least one post-baseline efficacy assessment of the study eye during the study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Timolol Maleate Opthalmic Solution 0.5% BID | Intraocular Pressure at Month 3 | 8:00 | 18.78 mmHg | Standard Error 0.249 |
| Timolol Maleate Opthalmic Solution 0.5% BID | Intraocular Pressure at Month 3 | 10:00 | 18.12 mmHg | Standard Error 0.244 |
| Timolol Maleate Opthalmic Solution 0.5% BID | Intraocular Pressure at Month 3 | 16:00 | 18.52 mmHg | Standard Error 0.228 |
| DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | Intraocular Pressure at Month 3 | 8:00 | 18.80 mmHg | Standard Error 0.244 |
| DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | Intraocular Pressure at Month 3 | 10:00 | 18.07 mmHg | Standard Error 0.239 |
| DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | Intraocular Pressure at Month 3 | 16:00 | 17.57 mmHg | Standard Error 0.223 |
Primary
Intraocular Pressure at Week 2
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Time frame: 08:00, 10:00 and 16:00 at Week 2
Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of the study medication (test or control medication) and had at least one post-baseline efficacy assessment of the study eye during the study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Timolol Maleate Opthalmic Solution 0.5% BID | Intraocular Pressure at Week 2 | 8:00 | 19.05 mmHg | Standard Error 0.242 |
| Timolol Maleate Opthalmic Solution 0.5% BID | Intraocular Pressure at Week 2 | 10:00 | 18.28 mmHg | Standard Error 0.219 |
| Timolol Maleate Opthalmic Solution 0.5% BID | Intraocular Pressure at Week 2 | 16:00 | 17.91 mmHg | Standard Error 0.215 |
| DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | Intraocular Pressure at Week 2 | 8:00 | 18.92 mmHg | Standard Error 0.239 |
| DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | Intraocular Pressure at Week 2 | 10:00 | 17.86 mmHg | Standard Error 0.216 |
| DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | Intraocular Pressure at Week 2 | 16:00 | 17.15 mmHg | Standard Error 0.212 |
Primary
Intraocular Pressure at Week 6
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Time frame: 08:00, 10:00 and 16:00 at Week 6
Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of the study medication (test or control medication) and had at least one post-baseline efficacy assessment of the study eye during the study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Timolol Maleate Opthalmic Solution 0.5% BID | Intraocular Pressure at Week 6 | 8:00 | 18.72 mmHg | Standard Error 0.238 |
| Timolol Maleate Opthalmic Solution 0.5% BID | Intraocular Pressure at Week 6 | 10:00 | 18.29 mmHg | Standard Error 0.238 |
| Timolol Maleate Opthalmic Solution 0.5% BID | Intraocular Pressure at Week 6 | 16:00 | 18.24 mmHg | Standard Error 0.235 |
| DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | Intraocular Pressure at Week 6 | 8:00 | 18.32 mmHg | Standard Error 0.233 |
| DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | Intraocular Pressure at Week 6 | 10:00 | 17.96 mmHg | Standard Error 0.233 |
| DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | Intraocular Pressure at Week 6 | 16:00 | 17.52 mmHg | Standard Error 0.229 |
Secondary
Mean Diurnal Intraocular Pressure at Month 3
Mean diurnal Intraocular Pressure (IOP) was defined as the mean of the IOP valued at the three schedules timepoints (8:00, 10:00 and 16:00) at that visit for that subject.
Time frame: Three months
Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of the study medication (test or control medication) and had at least one post-baseline efficacy assessment of the study eye during the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Timolol Maleate Opthalmic Solution 0.5% BID | Mean Diurnal Intraocular Pressure at Month 3 | 18.43 mmHg | Standard Error 0.209 |
| DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | Mean Diurnal Intraocular Pressure at Month 3 | 18.15 mmHg | Standard Error 0.205 |