Glaucoma Open-Angle Primary, Ocular Hypertension
Conditions
Brief summary
The trial will evaluate the safety and efficacy of 3 dose regimens of H-1337 \[0.6% twice daily (b.i.d.), 1.0% b.i.d. and 1.0% once in the morning (q.a.m.), and timolol maleate (0.5%, b.i.d.) in both eyes for 28 days.
Interventions
DRUGH-1337 0.6%
ophthalmic solution
DRUGH-1337 1.0%
ophthalmic solution
DRUGH-1337 Placebo
ophthalmic solution
DRUGTimolol 0.5%
ophthalmic solution
Sponsors
D. Western Therapeutics Institute, 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
* Diagnosis of bilateral primary open angle glaucoma or ocular hypertension
Exclusion criteria
* Closed or very narrow angles (Grades 0-1) or those the investigator judges as occludable and/or with evidence of peripheral anterior synechiae \>/= 180 degrees by gonioscopy within 6 months prior to screening visit in either eye Note: Other inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy as Assessed by Change in Intraocular Pressure | Day 28 | Mean change in intraocular pressure from baseline on Day 28 compared to timolol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy as Assessed by Intraocular Pressure | Day 0, Day 1, Day 7, Day 14, and Day 28 | Percentage of subjects reaching target intraocular pressure (≤18 mmHg) at each time point |
| Safety as Assessed by Adverse Event Reporting | Screening through Day 28 | Percentage of participants with ocular and systemic adverse events |
Countries
United States
Participant flow
Pre-assignment details
A 49-day screening period (screening visit plus washout period) occurred prior to randomization and the treatment period.
Participants by arm
| Arm | Count |
|---|---|
| H-1337 0.6% Ophthalmic Solution b.i.d. One drop H-1337 twice daily in the study eye for 28 days
H-1337 0.6%: ophthalmic solution | 51 |
| H-1337 1.0% Ophthalmic Solution b.i.d. One drop H-1337 twice daily in the study eye for 28 days
H-1337 1.0%: ophthalmic solution | 51 |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days
H-1337 1.0%: ophthalmic solution
H-1337 Placebo: ophthalmic solution | 50 |
| Timolol 0.5% Ophthalmic Solution b.i.d. One drop Timolol twice daily in the study eye for 28 days
Timolol 0.5%: ophthalmic solution | 49 |
| Total | 201 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 1 | 1 |
Baseline characteristics
| Characteristic | H-1337 0.6% Ophthalmic Solution b.i.d. | Total | Timolol 0.5% Ophthalmic Solution b.i.d. | H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | H-1337 1.0% Ophthalmic Solution b.i.d. |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 26 Participants | 109 Participants | 22 Participants | 31 Participants | 30 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 92 Participants | 27 Participants | 19 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 29 Participants | 5 Participants | 7 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 172 Participants | 44 Participants | 43 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Iris Color Blue | 10 Participants | 41 Participants | 9 Participants | 13 Participants | 9 Participants |
| Iris Color Brown | 30 Participants | 122 Participants | 34 Participants | 30 Participants | 28 Participants |
| Iris Color Green | 2 Participants | 9 Participants | 2 Participants | 1 Participants | 4 Participants |
| Iris Color Hazel | 9 Participants | 24 Participants | 3 Participants | 3 Participants | 9 Participants |
| Iris Color Other | 0 Participants | 5 Participants | 1 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 59 Participants | 17 Participants | 15 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 36 Participants | 139 Participants | 32 Participants | 35 Participants | 36 Participants |
| Sex: Female, Male Female | 26 Participants | 97 Participants | 19 Participants | 26 Participants | 26 Participants |
| Sex: Female, Male Male | 25 Participants | 104 Participants | 30 Participants | 24 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 51 | 0 / 50 | 0 / 49 |
| other Total, other adverse events | 19 / 51 | 28 / 51 | 29 / 50 | 8 / 49 |
| serious Total, serious adverse events | 0 / 51 | 0 / 51 | 0 / 50 | 0 / 49 |
Outcome results
Primary
Efficacy as Assessed by Change in Intraocular Pressure
Mean change in intraocular pressure from baseline on Day 28 compared to timolol
Time frame: Day 28
Population: Intent-to-Treat (ITT) is defined as all randomized subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: Pre T0, change from baseline (mmHg) | -6.3 mmHg | Standard Deviation 3.27 |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: 8-hour diurnal, change from baseline (mmHg) | -7.2 mmHg | Standard Deviation 3.04 |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: T0 + 12h, change from baseline (mmHg) | -5.6 mmHg | Standard Deviation 3.82 |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: T0 + 2h, change from baseline (mmHg) | -7.3 mmHg | Standard Deviation 3.07 |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: 12-hour diurnal, change from baseline (mmHg) | -6.8 mmHg | Standard Deviation 3.02 |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: T0 + 4h, change from baseline (mmHg) | -7.5 mmHg | Standard Deviation 3.28 |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: T0 + 8h, change from baseline (mmHg) | -6.8 mmHg | Standard Deviation 3.67 |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: 8-hour diurnal, change from baseline (mmHg) | -7.0 mmHg | Standard Deviation 2.9 |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: T0 + 8h, change from baseline (mmHg) | -6.5 mmHg | Standard Deviation 3.5 |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: T0 + 4h, change from baseline (mmHg) | -7.3 mmHg | Standard Deviation 3.24 |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: T0 + 12h, change from baseline (mmHg) | -5.3 mmHg | Standard Deviation 3.37 |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: 12-hour diurnal, change from baseline (mmHg) | -6.6 mmHg | Standard Deviation 2.76 |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: T0 + 2h, change from baseline (mmHg) | -7.2 mmHg | Standard Deviation 3.14 |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: Pre T0, change from baseline (mmHg) | -6.3 mmHg | Standard Deviation 3.15 |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: T0 + 8h, change from baseline (mmHg) | -6.1 mmHg | Standard Deviation 3.12 |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: Pre T0, change from baseline (mmHg) | -5.9 mmHg | Standard Deviation 3.45 |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: T0 + 2h, change from baseline (mmHg) | -6.5 mmHg | Standard Deviation 3.67 |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: T0 + 4h, change from baseline (mmHg) | -6.8 mmHg | Standard Deviation 3.48 |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: T0 + 12h, change from baseline (mmHg) | -5.5 mmHg | Standard Deviation 3.44 |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: 8-hour diurnal, change from baseline (mmHg) | -6.4 mmHg | Standard Deviation 3.14 |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: 12-hour diurnal, change from baseline (mmHg) | -6.2 mmHg | Standard Deviation 3.11 |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: T0 + 4h, change from baseline (mmHg) | -5.3 mmHg | Standard Deviation 3.53 |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: 12-hour diurnal, change from baseline (mmHg) | -5.4 mmHg | Standard Deviation 2.99 |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: 8-hour diurnal, change from baseline (mmHg) | -5.6 mmHg | Standard Deviation 3.16 |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: T0 + 2h, change from baseline (mmHg) | -6.3 mmHg | Standard Deviation 3.83 |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: Pre T0, change from baseline (mmHg) | -7.0 mmHg | Standard Deviation 3.26 |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: T0 + 12h, change from baseline (mmHg) | -4.9 mmHg | Standard Deviation 3.35 |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Change in Intraocular Pressure | Day 28: T0 + 8h, change from baseline (mmHg) | -5.3 mmHg | Standard Deviation 3.21 |
Secondary
Efficacy as Assessed by Intraocular Pressure
Percentage of subjects reaching target intraocular pressure (≤18 mmHg) at each time point
Time frame: Day 0, Day 1, Day 7, Day 14, and Day 28
Population: Intent-to-Treat (ITT) is defined as all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 0: Pre T0 | 0.0 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 28: T0 + 2h | 66.7 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 1: 12-hour diurnal | 54.9 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 0: T0 + 8h | 5.9 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 1: 8-hour diurnal | 47.1 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 28: Pre T0 | 31.4 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 7: Pre T0 | 37.3 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 0: T0 + 2h | 0.0 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 14: Pre T0 | 41.2 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 28: 12-hour diurnal | 58.8 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 0: T0 + 12h | 10.9 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 0: 12-hour diurnal | 2.0 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 28: T0 + 12h | 67.4 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 0: 8-hour diurnal | 0.0 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 28: 8-hour diurnal | 64.7 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 1: Pre T0 | 0.0 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 0: T0 + 4h | 2.0 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 28: T0 + 8h | 68.6 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 1: T0 + 2h | 31.4 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 1: T0 + 4h | 51.0 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 28: T0 + 4h | 74.5 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 1: T0 + 8h | 60.8 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 1: T0 + 12h | 67.4 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 28: T0 + 4h | 81.6 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 28: 12-hour diurnal | 63.3 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 0: 8-hour diurnal | 2.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 1: 12-hour diurnal | 54.9 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 1: T0 + 4h | 58.8 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 28: Pre T0 | 40.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 28: T0 + 8h | 77.6 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 1: 8-hour diurnal | 51.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 0: T0 + 8h | 3.9 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 28: 8-hour diurnal | 67.3 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 1: Pre T0 | 0.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 7: Pre T0 | 30.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 28: T0 + 2h | 63.3 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 14: Pre T0 | 36.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 1: T0 + 12h | 72.3 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 1: T0 + 8h | 68.6 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 1: T0 + 2h | 35.3 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 0: T0 + 12h | 10.9 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 0: T0 + 2h | 3.9 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 28: T0 + 12h | 68.9 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 0: T0 + 4h | 2.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 0: 12-hour diurnal | 2.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 0: Pre T0 | 2.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 1: T0 + 12h | 84.4 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 0: Pre T0 | 0.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 0: T0 + 2h | 4.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 0: T0 + 4h | 2.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 0: T0 + 8h | 6.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 0: T0 + 12h | 15.2 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 0: 12-hour diurnal | 2.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 0: 8-hour diurnal | 2.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 1: Pre T0 | 0.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 1: T0 + 2h | 28.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 1: T0 + 4h | 70.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 1: T0 + 8h | 74.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 1: 12-hour diurnal | 52.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 1: 8-hour diurnal | 52.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 7: Pre T0 | 20.4 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 14: Pre T0 | 26.5 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 28: Pre T0 | 34.7 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 28: T0 + 2h | 55.1 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 28: T0 + 4h | 79.6 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 28: T0 + 8h | 67.3 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 28: T0 + 12h | 71.1 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 28: 12-hour diurnal | 65.3 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Efficacy as Assessed by Intraocular Pressure | Day 28: 8-hour diurnal | 65.3 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 1: T0 + 8h | 61.2 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 28: 8-hour diurnal | 50.0 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 28: T0 + 2h | 58.3 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 1: T0 + 4h | 63.3 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 1: T0 + 2h | 46.9 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 28: 12-hour diurnal | 54.2 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 28: T0 + 4h | 52.1 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 1: Pre T0 | 0.0 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 0: 8-hour diurnal | 2.0 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 0: T0 + 2h | 2.0 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 28: T0 + 8h | 62.5 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 0: 12-hour diurnal | 2.0 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 0: T0 + 12h | 13.3 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 0: Pre T0 | 0.0 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 28: T0 + 12h | 64.4 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 7: Pre T0 | 44.9 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 0: T0 + 8h | 6.1 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 14: Pre T0 | 47.9 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 1: 8-hour diurnal | 53.1 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 1: 12-hour diurnal | 53.1 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 0: T0 + 4h | 2.0 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 28: Pre T0 | 52.1 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Efficacy as Assessed by Intraocular Pressure | Day 1: T0 + 12h | 76.1 percentage of subjects |
Secondary
Safety as Assessed by Adverse Event Reporting
Percentage of participants with ocular and systemic adverse events
Time frame: Screening through Day 28
Population: Safety population is defined as all randomized subjects who received at least one dose of investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| H-1337 0.6% Ophthalmic Solution b.i.d. | Safety as Assessed by Adverse Event Reporting | Ocular Treatment-Emergent Adverse Events | 43.1 percentage of subjects |
| H-1337 0.6% Ophthalmic Solution b.i.d. | Safety as Assessed by Adverse Event Reporting | Systemic Treatment-Emergent Adverse Events | 3.9 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Safety as Assessed by Adverse Event Reporting | Systemic Treatment-Emergent Adverse Events | 7.8 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution b.i.d. | Safety as Assessed by Adverse Event Reporting | Ocular Treatment-Emergent Adverse Events | 60.8 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Safety as Assessed by Adverse Event Reporting | Ocular Treatment-Emergent Adverse Events | 64.0 percentage of subjects |
| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Safety as Assessed by Adverse Event Reporting | Systemic Treatment-Emergent Adverse Events | 4.0 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Safety as Assessed by Adverse Event Reporting | Ocular Treatment-Emergent Adverse Events | 18.4 percentage of subjects |
| Timolol 0.5% Ophthalmic Solution b.i.d. | Safety as Assessed by Adverse Event Reporting | Systemic Treatment-Emergent Adverse Events | 2.0 percentage of subjects |