Ocular Hypertension, Open Angle Glaucoma
Conditions
Keywords
Primary open angle glaucoma or ocular hypertension
Brief summary
DE-111 ophthalmic solution will be evaluated for superiority in comparison with Timolol ophthalmic solution 0.5%, in IOP(intraocular pressure ) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Safety will be compared and evaluated as well.
Interventions
Sponsors
Santen Pharmaceutical Co., Ltd.
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Inclusion criteria
* Diagnosed with primary open angle glaucoma or ocular hypertension * Provided signed, written informed consent * 20 years of age and older * If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study
Exclusion criteria
* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception * Presence of any abnormality or significant illness that could be expected to interfere with the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study | Week 0(Baseline) and Week 4(End of Study) | Mean diurnal IOP (intraocular pressure) was calculated as an average of IOP (intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30. |
Countries
Japan
Participant flow
Pre-assignment details
Prior to randomization all participants in the study were receiving Timolol ophthalmic solution 0.5% (one drop at a time, BID).
Participants by arm
| Arm | Count |
|---|---|
| DE-111 DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes. | 82 |
| Timolol Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes. | 84 |
| Total | 166 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 0 |
| Overall Study | Not meeting inclusion/exclusion criteria | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Timolol | DE-111 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 49 Participants | 36 Participants | 85 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 46 Participants | 81 Participants |
| Age, Continuous | 63.1 years STANDARD_DEVIATION 12.4 | 61.6 years STANDARD_DEVIATION 11.4 | 62.4 years STANDARD_DEVIATION 11.9 |
| Region of Enrollment Japan | 84 participants | 82 participants | 166 participants |
| Sex: Female, Male Female | 46 Participants | 44 Participants | 90 Participants |
| Sex: Female, Male Male | 38 Participants | 38 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 82 | 2 / 84 |
| serious Total, serious adverse events | 0 / 82 | 0 / 84 |
Outcome results
Primary
Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study
Mean diurnal IOP (intraocular pressure) was calculated as an average of IOP (intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.
Time frame: Week 0(Baseline) and Week 4(End of Study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DE-111 | Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study | -3.2 mmHg | Standard Deviation 2.1 |
| Timolol | Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study | -1.7 mmHg | Standard Deviation 2.1 |
p-value: <0.00195% CI: [-2.2, -0.9]ANCOVA