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 Tafluprost 0.0015% ophthalmic solution, or for non-inferiority in comparison with Tafluprost 0.0015% and Timolol ophthalmic solution 0.5% used concomitantly, 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
DRUGTafluprost ophthalmic solution 0.0015%
DRUGConcomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%
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
Switched to following three arms randomly from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily).
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. | 161 |
| Tafluprost Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes. | 163 |
| Tafluprost Plus Timolol Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes. | 163 |
| Total | 487 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Did not receive allocated intervention | 0 | 0 | 1 |
| Overall Study | Physician Decision | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Tafluprost | Tafluprost Plus Timolol | DE-111 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 82 Participants | 76 Participants | 69 Participants | 227 Participants |
| Age, Categorical Between 18 and 65 years | 81 Participants | 87 Participants | 92 Participants | 260 Participants |
| Age, Continuous | 63.0 years STANDARD_DEVIATION 12.6 | 60.6 years STANDARD_DEVIATION 13.6 | 61.6 years STANDARD_DEVIATION 11.6 | 61.7 years STANDARD_DEVIATION 12.7 |
| Region of Enrollment Japan | 163 participants | 163 participants | 161 participants | 487 participants |
| Sex: Female, Male Female | 95 Participants | 81 Participants | 76 Participants | 252 Participants |
| Sex: Female, Male Male | 68 Participants | 82 Participants | 85 Participants | 235 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 161 | 0 / 164 | 0 / 163 |
| serious Total, serious adverse events | 0 / 161 | 0 / 164 | 0 / 163 |
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 | -2.6 mmHg | Standard Deviation 1.8 |
| Tafluprost | Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study | -0.9 mmHg | Standard Deviation 1.7 |
| Tafluprost Plus Timolol | Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study | -2.2 mmHg | Standard Deviation 1.8 |
p-value: <0.00195% CI: [-2.1, -1.3]ANCOVA
Comparison: Non-inferiority was evaluated after superiority to tafluprost was confirmed.95% CI: [-0.7, 0.1]