Ocular Hypertension, Primary Open Angle Glaucoma
Conditions
Brief summary
This is a phase 2, double masked, randomized, multi-center, parallel-group, 28-day study assessing the safety, tolerability and ocular hypotensive efficacy of AKB-9778 Ophthalmic Solution 4.0% administered once (AM) or twice (AM & PM) daily when used as an adjunctive therapy to latanoprost ophthalmic solution 0.005% once daily (PM) in subjects with elevated IOP due to OAG or OHT.
Interventions
DRUGPlacebo
placebo for razuprotafib opthalmic solution
Latanoprost opthalmic solution to be dosed once daily
DRUGAKB-9778 4%
Razuprotafib opthalmic solution
Sponsors
EyePoint Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Diagnosis of OAG or OHT in each eye (OAG in one eye and OHT in the fellow eye is acceptable) * Must be receiving treatment with a stable regimen of topical prostaglandin eyedrop for a minimum of 2 weeks prior to the Screening Visit; may be taking one additional IOP lowering eyedrop * IOP of ≥ 18 mmHg and ≤ 27 mmHg in one eye or both eyes at Screening visit * Following 4 week washout period, IOP ≥ 24 mmHg and \< 36 mmHg at 08:00 hour and IOP ≥ 22 mmHg and \< 36 mmHg in both eyes at 10:00, 12:00 and 16:00 hours. Key
Exclusion criteria
* Clinically significant ocular disease which might interfere with interpretation of the study efficacy endpoints or with safety assessments * Pseudoexfoliation or pigment dispersion component glaucoma * History of angle closure glaucoma, or narrow angles or with evidence of peripheral anterior synechiae (PAS) ≥ 180 degrees by gonioscopy within 6 months prior to Screening * Intraocular pressure ≥ 36 mmHg * Cup/disc ratio of \> 0.8 in either eye * Severe visual field defect or significant defect (sensitivity of ≤ 10dB) within 10 degrees of fixation in either eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Intraocular Pressure at Day 28 (Study Eye) | Baseline to Day 28 | Change from Baseline in Diurnal Mean IOP (mmHg) at Day 28 in the Study Eye -- ITT Population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes) | Baseline to Day 14 and Baseline to Day 28 | Mean change from baseline in diurnal mean IOP (measured in mmHg) at Day 14 and 28 in both eyes - ITT Population |
| Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes) | Baseline to Day 14 and Baseline to Day 28 | Mean of the Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in both eyes -- ITT Population |
| Mean Observed IOP at Each Time Point on Days 14 and 28 | Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28 | Mean observed IOP measured in mmHg at each time point on Days 14 and 28 (study eye) - ITT Population |
| Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye) | Baseline to Day 14 | Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 in the Study Eye -- ITT Population |
| Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28 | Percent Change from Baseline IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population |
| Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28 | Baseline to Day 14 and Baseline to Day 28 | Percent Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in the Study Eye -- ITT Population |
| Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Baseline to Day 28 | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels in Study Eye -- ITT Population |
| Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28 | Change from Baseline in Mean IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AKB-9778 4% QD + Latanoprost • AKB-9778 4%(AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily
Razuprotafib: razuprotafib opthalmic solution | 65 |
| AKB-9778 4% QD + Latanoprost • AKB-9778 4%(AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily
Razuprotafib: razuprotafib opthalmic solution | 130 |
| AKB-9778 4% BID + Latanoprost • AKB-9778 4% BID (AM & PM) plus latanoprost daily (PM) for 28 days
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily
Razuprotafib: razuprotafib opthalmic solution | 65 |
| AKB-9778 4% BID + Latanoprost • AKB-9778 4% BID (AM & PM) plus latanoprost daily (PM) for 28 days
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily
Razuprotafib: razuprotafib opthalmic solution | 130 |
| Placebo Twice Daily + Latanoprost • Placebo for AKB-9778 4% twice daily (AM & PM) plus latanoprost daily (PM) for 28 days
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily
Placebo: placebo for razuprotafib opthalmic solution | 64 |
| Placebo Twice Daily + Latanoprost • Placebo for AKB-9778 4% twice daily (AM & PM) plus latanoprost daily (PM) for 28 days
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily
Placebo: placebo for razuprotafib opthalmic solution | 128 |
| Total | 582 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | AKB-9778 4% QD + Latanoprost | AKB-9778 4% BID + Latanoprost | Placebo Twice Daily + Latanoprost | Total |
|---|---|---|---|---|
| Age, Continuous | 68.3 years STANDARD_DEVIATION 8.81 | 65.6 years STANDARD_DEVIATION 10.85 | 65.9 years STANDARD_DEVIATION 10.55 | 66.6 years STANDARD_DEVIATION 10.13 |
| Diagnosis Ocular hypertension - Fellow Eye | 32 Eyes | 23 Eyes | 22 Eyes | 77 Eyes |
| Diagnosis Ocular hypertension - Study Eye | 32 Eyes | 22 Eyes | 22 Eyes | 76 Eyes |
| Diagnosis Open-angle glaucoma - Fellow Eye | 33 Eyes | 42 Eyes | 42 Eyes | 117 Eyes |
| Diagnosis Open-angle glaucoma - Study Eye | 33 Eyes | 43 Eyes | 42 Eyes | 118 Eyes |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 6 Participants | 3 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 59 Participants | 61 Participants | 176 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 17 Participants | 16 Participants | 53 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 45 Participants | 47 Participants | 47 Participants | 139 Participants |
| Randomization Intraocular Pressure (Study Eye) Diurnal Mean < 26 mmHg | 49 Participants | 49 Participants | 48 Participants | 146 Participants |
| Randomization Intraocular Pressure (Study Eye) Diurnal Mean >=26 mmHg | 16 Participants | 16 Participants | 16 Participants | 48 Participants |
| Sex: Female, Male Female | 40 Participants | 37 Participants | 43 Participants | 120 Participants |
| Sex: Female, Male Male | 25 Participants | 28 Participants | 21 Participants | 74 Participants |
| Study Eye Baseline Diurnal Mean Intraocular Pressure (mmHg) | 24.83 mmHg STANDARD_DEVIATION 1.559 | 25.16 mmHg STANDARD_DEVIATION 2.039 | 25.11 mmHg STANDARD_DEVIATION 1.967 | 25.03 mmHg STANDARD_DEVIATION 1.862 |
| Study Eye Screening Corneal Thickness (micrometers) | 544.8 micrometer STANDARD_DEVIATION 30.27 | 554.0 micrometer STANDARD_DEVIATION 28.57 | 554.7 micrometer STANDARD_DEVIATION 30.58 | 551.2 micrometer STANDARD_DEVIATION 30 |
| Study Eye Screening Intraocular Pressure (mmHg) | 20.34 mmHg STANDARD_DEVIATION 1.981 | 20.54 mmHg STANDARD_DEVIATION 2.283 | 20.11 mmHg STANDARD_DEVIATION 2.003 | 20.33 mmHg STANDARD_DEVIATION 2.091 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 65 | 0 / 64 |
| other Total, other adverse events | 30 / 65 | 43 / 65 | 19 / 64 |
| serious Total, serious adverse events | 0 / 65 | 0 / 65 | 0 / 64 |
Outcome results
Primary
Change From Baseline in Intraocular Pressure at Day 28 (Study Eye)
Change from Baseline in Diurnal Mean IOP (mmHg) at Day 28 in the Study Eye -- ITT Population
Time frame: Baseline to Day 28
Population: The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AKB-9778 4% QD + Latanoprost | Change From Baseline in Intraocular Pressure at Day 28 (Study Eye) | -6.95 mmHg | Standard Error 0.258 |
| AKB-9778 4% BID + Latanoprost | Change From Baseline in Intraocular Pressure at Day 28 (Study Eye) | -7.95 mmHg | Standard Error 0.257 |
| Placebo Twice Daily + Latanoprost | Change From Baseline in Intraocular Pressure at Day 28 (Study Eye) | -7.04 mmHg | Standard Error 0.259 |
p-value: 0.80795% CI: [-0.63, 0.81]ANCOVA
p-value: 0.01395% CI: [-1.64, -0.2]ANCOVA
Secondary
Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye)
Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 in the Study Eye -- ITT Population
Time frame: Baseline to Day 14
Population: The Intent-to-Treat population includes all randomized subjects who received at least one dose of study medication. the primary population for efficacy analyses and was used to summarize all efficacy variables and summarizes subjects as randomized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AKB-9778 4% QD + Latanoprost | Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye) | -6.75 mmHg | Standard Error 0.259 |
| AKB-9778 4% BID + Latanoprost | Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye) | -7.62 mmHg | Standard Error 0.258 |
| Placebo Twice Daily + Latanoprost | Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye) | -7.03 mmHg | Standard Error 0.26 |
Secondary
Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes)
Mean change from baseline in diurnal mean IOP (measured in mmHg) at Day 14 and 28 in both eyes - ITT Population
Time frame: Baseline to Day 14 and Baseline to Day 28
Population: The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AKB-9778 4% QD + Latanoprost | Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes) | Baseline to Day 14 | -6.68 mmHg | Standard Error 0.25 |
| AKB-9778 4% QD + Latanoprost | Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes) | Baseline to Day 28 | -6.83 mmHg | Standard Error 0.255 |
| AKB-9778 4% BID + Latanoprost | Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes) | Baseline to Day 14 | -7.53 mmHg | Standard Error 0.25 |
| AKB-9778 4% BID + Latanoprost | Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes) | Baseline to Day 28 | -7.86 mmHg | Standard Error 0.255 |
| Placebo Twice Daily + Latanoprost | Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes) | Baseline to Day 14 | -6.91 mmHg | Standard Error 0.252 |
| Placebo Twice Daily + Latanoprost | Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes) | Baseline to Day 28 | -6.93 mmHg | Standard Error 0.257 |
Secondary
Mean Change From Baseline IOP at Each Time Point on Days 14 and 28
Change from Baseline in Mean IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population
Time frame: Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28
Population: The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AKB-9778 4% QD + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 08:00 | -6.66 mmHg | Standard Deviation 2.551 |
| AKB-9778 4% QD + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 10:00 | -7.02 mmHg | Standard Deviation 2.607 |
| AKB-9778 4% QD + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 12:00 | -6.79 mmHg | Standard Deviation 2.378 |
| AKB-9778 4% QD + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 16:00 | -6.29 mmHg | Standard Deviation 2.698 |
| AKB-9778 4% QD + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 08:00 | -7.39 mmHg | Standard Deviation 2.977 |
| AKB-9778 4% QD + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 10:00 | -7.03 mmHg | Standard Deviation 2.665 |
| AKB-9778 4% QD + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 12:00 | -6.69 mmHg | Standard Deviation 2.383 |
| AKB-9778 4% QD + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 16:00 | -6.45 mmHg | Standard Deviation 2.279 |
| AKB-9778 4% BID + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 12:00 | -7.52 mmHg | Standard Deviation 2.761 |
| AKB-9778 4% BID + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 12:00 | -8.21 mmHg | Standard Deviation 2.486 |
| AKB-9778 4% BID + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 16:00 | -7.10 mmHg | Standard Deviation 2.841 |
| AKB-9778 4% BID + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 08:00 | -8.25 mmHg | Standard Deviation 2.826 |
| AKB-9778 4% BID + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 10:00 | -8.19 mmHg | Standard Deviation 2.536 |
| AKB-9778 4% BID + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 08:00 | -8.13 mmHg | Standard Deviation 3.225 |
| AKB-9778 4% BID + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 10:00 | -7.88 mmHg | Standard Deviation 2.831 |
| AKB-9778 4% BID + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 16:00 | -7.30 mmHg | Standard Deviation 2.731 |
| Placebo Twice Daily + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 12:00 | -6.83 mmHg | Standard Deviation 2.381 |
| Placebo Twice Daily + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 10:00 | -7.45 mmHg | Standard Deviation 2.388 |
| Placebo Twice Daily + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 08:00 | -7.59 mmHg | Standard Deviation 3.13 |
| Placebo Twice Daily + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 16:00 | -6.36 mmHg | Standard Deviation 2.332 |
| Placebo Twice Daily + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 12:00 | -7.18 mmHg | Standard Deviation 2.598 |
| Placebo Twice Daily + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 10:00 | -7.57 mmHg | Standard Deviation 2.549 |
| Placebo Twice Daily + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 08:00 | -7.38 mmHg | Standard Deviation 2.715 |
| Placebo Twice Daily + Latanoprost | Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 16:00 | -6.10 mmHg | Standard Deviation 2.593 |
Secondary
Mean Observed IOP at Each Time Point on Days 14 and 28
Mean observed IOP measured in mmHg at each time point on Days 14 and 28 (study eye) - ITT Population
Time frame: Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28
Population: The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AKB-9778 4% QD + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 14, 08:00 | 19.54 mmHg | Standard Deviation 2.97 |
| AKB-9778 4% QD + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 14, 10:00 | 17.98 mmHg | Standard Deviation 2.907 |
| AKB-9778 4% QD + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 14, 12:00 | 17.50 mmHg | Standard Deviation 3.059 |
| AKB-9778 4% QD + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 14, 16:00 | 17.52 mmHg | Standard Deviation 2.805 |
| AKB-9778 4% QD + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 28, 08:00 | 18.81 mmHg | Standard Deviation 2.977 |
| AKB-9778 4% QD + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 28, 10:00 | 17.97 mmHg | Standard Deviation 2.878 |
| AKB-9778 4% QD + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 28, 12:00 | 17.60 mmHg | Standard Deviation 2.791 |
| AKB-9778 4% QD + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 28, 16:00 | 17.35 mmHg | Standard Deviation 2.507 |
| AKB-9778 4% BID + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 14, 12:00 | 17.25 mmHg | Standard Deviation 2.767 |
| AKB-9778 4% BID + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 28, 12:00 | 16.55 mmHg | Standard Deviation 2.695 |
| AKB-9778 4% BID + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 14, 16:00 | 17.17 mmHg | Standard Deviation 2.762 |
| AKB-9778 4% BID + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 28, 08:00 | 18.13 mmHg | Standard Deviation 2.417 |
| AKB-9778 4% BID + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 28, 10:00 | 17.02 mmHg | Standard Deviation 2.558 |
| AKB-9778 4% BID + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 14, 08:00 | 18.25 mmHg | Standard Deviation 2.652 |
| AKB-9778 4% BID + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 14, 10:00 | 17.32 mmHg | Standard Deviation 2.772 |
| AKB-9778 4% BID + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 28, 16:00 | 16.97 mmHg | Standard Deviation 2.377 |
| Placebo Twice Daily + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 14, 12:00 | 17.87 mmHg | Standard Deviation 2.624 |
| Placebo Twice Daily + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 14, 10:00 | 18.02 mmHg | Standard Deviation 2.973 |
| Placebo Twice Daily + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 14, 08:00 | 18.75 mmHg | Standard Deviation 3.289 |
| Placebo Twice Daily + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 14, 16:00 | 17.56 mmHg | Standard Deviation 2.696 |
| Placebo Twice Daily + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 28, 12:00 | 17.51 mmHg | Standard Deviation 2.914 |
| Placebo Twice Daily + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 28, 10:00 | 17.90 mmHg | Standard Deviation 2.986 |
| Placebo Twice Daily + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 28, 08:00 | 18.95 mmHg | Standard Deviation 2.986 |
| Placebo Twice Daily + Latanoprost | Mean Observed IOP at Each Time Point on Days 14 and 28 | Day 28, 16:00 | 17.82 mmHg | Standard Deviation 3.052 |
Secondary
Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28
Percent Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in the Study Eye -- ITT Population
Time frame: Baseline to Day 14 and Baseline to Day 28
Population: The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AKB-9778 4% QD + Latanoprost | Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28 | Baseline to Day 14 | -27.08 percent change | Standard Deviation 7.875 |
| AKB-9778 4% QD + Latanoprost | Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28 | Baseline to Day 28 | -27.83 percent change | Standard Deviation 8.711 |
| AKB-9778 4% BID + Latanoprost | Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28 | Baseline to Day 14 | -30.29 percent change | Standard Deviation 8.55 |
| AKB-9778 4% BID + Latanoprost | Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28 | Baseline to Day 28 | -31.67 percent change | Standard Deviation 7.219 |
| Placebo Twice Daily + Latanoprost | Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28 | Baseline to Day 14 | -28.16 percent change | Standard Deviation 7.931 |
| Placebo Twice Daily + Latanoprost | Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28 | Baseline to Day 28 | -28.19 percent change | Standard Deviation 8.523 |
Secondary
Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28
Percent Change from Baseline IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population
Time frame: Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28
Population: The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AKB-9778 4% QD + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 08:00 | -25.52 percent change | Standard Error 1.292 |
| AKB-9778 4% QD + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 10:00 | -28.09 percent change | Standard Error 1.221 |
| AKB-9778 4% QD + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 12:00 | -28.21 percent change | Standard Error 1.213 |
| AKB-9778 4% QD + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 16:00 | -26.48 percent change | Standard Error 1.285 |
| AKB-9778 4% QD + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 08:00 | -28.19 percent change | Standard Error 1.218 |
| AKB-9778 4% QD + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 10:00 | -28.12 percent change | Standard Error 1.207 |
| AKB-9778 4% QD + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 12:00 | -27.65 percent change | Standard Error 1.209 |
| AKB-9778 4% QD + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 16:00 | -27.21 percent change | Standard Error 1.227 |
| AKB-9778 4% BID + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 12:00 | -30.19 percent change | Standard Error 1.211 |
| AKB-9778 4% BID + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 12:00 | -33.09 percent change | Standard Error 1.206 |
| AKB-9778 4% BID + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 16:00 | -28.94 percent change | Standard Error 1.287 |
| AKB-9778 4% BID + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 08:00 | -30.96 percent change | Standard Error 1.218 |
| AKB-9778 4% BID + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 10:00 | -32.36 percent change | Standard Error 1.205 |
| AKB-9778 4% BID + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 08:00 | -30.41 percent change | Standard Error 1.291 |
| AKB-9778 4% BID + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 10:00 | -31.10 percent change | Standard Error 1.219 |
| AKB-9778 4% BID + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 16:00 | -29.65 percent change | Standard Error 1.229 |
| Placebo Twice Daily + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 12:00 | -27.53 percent change | Standard Error 1.219 |
| Placebo Twice Daily + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 10:00 | -29.29 percent change | Standard Error 1.231 |
| Placebo Twice Daily + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 08:00 | -28.68 percent change | Standard Error 1.301 |
| Placebo Twice Daily + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 14, 16:00 | -26.61 percent change | Standard Error 1.293 |
| Placebo Twice Daily + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 12:00 | -29.03 percent change | Standard Error 1.215 |
| Placebo Twice Daily + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 10:00 | -29.70 percent change | Standard Error 1.217 |
| Placebo Twice Daily + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 08:00 | -27.93 percent change | Standard Error 1.227 |
| Placebo Twice Daily + Latanoprost | Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 | Day 28, 16:00 | -25.58 percent change | Standard Error 1.235 |
Secondary
Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes)
Mean of the Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in both eyes -- ITT Population
Time frame: Baseline to Day 14 and Baseline to Day 28
Population: The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AKB-9778 4% QD + Latanoprost | Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes) | Baseline to Day 14 | 18.01 mmHg | Standard Deviation 2.445 |
| AKB-9778 4% QD + Latanoprost | Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes) | Baseline to Day 28 | 17.86 mmHg | Standard Deviation 2.514 |
| AKB-9778 4% BID + Latanoprost | Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes) | Baseline to Day 14 | 17.37 mmHg | Standard Deviation 2.272 |
| AKB-9778 4% BID + Latanoprost | Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes) | Baseline to Day 28 | 17.03 mmHg | Standard Deviation 2.019 |
| Placebo Twice Daily + Latanoprost | Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes) | Baseline to Day 14 | 17.95 mmHg | Standard Deviation 2.383 |
| Placebo Twice Daily + Latanoprost | Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes) | Baseline to Day 28 | 17.92 mmHg | Standard Deviation 2.58 |
Secondary
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels in Study Eye -- ITT Population
Time frame: Baseline to Day 28
Population: The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AKB-9778 4% QD + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentage of Subjects Achieving Pre-Specified Mean IOP: <=18 mmHg | 35 Participants |
| AKB-9778 4% QD + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=25% | 43 Participants |
| AKB-9778 4% QD + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=3 mmHg | 62 Participants |
| AKB-9778 4% QD + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentage of Subjects Achieving Pre-Specified Mean IOP: <=20 mmHg | 56 Participants |
| AKB-9778 4% QD + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=30% | 25 Participants |
| AKB-9778 4% QD + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=5% | 63 Participants |
| AKB-9778 4% QD + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentage of Subjects Achieving Pre-Specified Mean IOP: <=22 mmHg | 60 Participants |
| AKB-9778 4% QD + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=35% | 13 Participants |
| AKB-9778 4% QD + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=6 mmHg | 47 Participants |
| AKB-9778 4% QD + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=40% | 4 Participants |
| AKB-9778 4% QD + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=2 mmHg | 63 Participants |
| AKB-9778 4% QD + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=10% | 62 Participants |
| AKB-9778 4% QD + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=4 mmHg | 61 Participants |
| AKB-9778 4% QD + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentage of Subjects Achieving Pre-Specified Mean IOP : <=14 mmHg | 3 Participants |
| AKB-9778 4% QD + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=15% | 61 Participants |
| AKB-9778 4% QD + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=10 mmHg | 3 Participants |
| AKB-9778 4% QD + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentage of Subjects Achieving Pre-Specified Mean IOP: <=16 mmHg | 14 Participants |
| AKB-9778 4% QD + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=20% | 57 Participants |
| AKB-9778 4% QD + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=8 mmHg | 21 Participants |
| AKB-9778 4% BID + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=6 mmHg | 57 Participants |
| AKB-9778 4% BID + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=8 mmHg | 32 Participants |
| AKB-9778 4% BID + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=10 mmHg | 9 Participants |
| AKB-9778 4% BID + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=5% | 65 Participants |
| AKB-9778 4% BID + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=10% | 65 Participants |
| AKB-9778 4% BID + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=15% | 64 Participants |
| AKB-9778 4% BID + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=20% | 62 Participants |
| AKB-9778 4% BID + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=25% | 55 Participants |
| AKB-9778 4% BID + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=30% | 40 Participants |
| AKB-9778 4% BID + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=35% | 18 Participants |
| AKB-9778 4% BID + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentage of Subjects Achieving Pre-Specified Mean IOP: <=22 mmHg | 63 Participants |
| AKB-9778 4% BID + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentage of Subjects Achieving Pre-Specified Mean IOP: <=20 mmHg | 60 Participants |
| AKB-9778 4% BID + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentage of Subjects Achieving Pre-Specified Mean IOP: <=18 mmHg | 46 Participants |
| AKB-9778 4% BID + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentage of Subjects Achieving Pre-Specified Mean IOP: <=16 mmHg | 20 Participants |
| AKB-9778 4% BID + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentage of Subjects Achieving Pre-Specified Mean IOP : <=14 mmHg | 6 Participants |
| AKB-9778 4% BID + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=2 mmHg | 65 Participants |
| AKB-9778 4% BID + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=3 mmHg | 65 Participants |
| AKB-9778 4% BID + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=4 mmHg | 64 Participants |
| AKB-9778 4% BID + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=40% | 10 Participants |
| Placebo Twice Daily + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=4 mmHg | 60 Participants |
| Placebo Twice Daily + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentage of Subjects Achieving Pre-Specified Mean IOP: <=18 mmHg | 35 Participants |
| Placebo Twice Daily + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=15% | 59 Participants |
| Placebo Twice Daily + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=3 mmHg | 63 Participants |
| Placebo Twice Daily + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentage of Subjects Achieving Pre-Specified Mean IOP: <=16 mmHg | 13 Participants |
| Placebo Twice Daily + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=10% | 63 Participants |
| Placebo Twice Daily + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=8 mmHg | 20 Participants |
| Placebo Twice Daily + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentage of Subjects Achieving Pre-Specified Mean IOP : <=14 mmHg | 4 Participants |
| Placebo Twice Daily + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=5% | 64 Participants |
| Placebo Twice Daily + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=6 mmHg | 44 Participants |
| Placebo Twice Daily + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=35% | 11 Participants |
| Placebo Twice Daily + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=40% | 4 Participants |
| Placebo Twice Daily + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=30% | 27 Participants |
| Placebo Twice Daily + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=2 mmHg | 64 Participants |
| Placebo Twice Daily + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentage of Subjects Achieving Pre-Specified Mean IOP: <=22 mmHg | 58 Participants |
| Placebo Twice Daily + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=25% | 41 Participants |
| Placebo Twice Daily + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=10 mmHg | 4 Participants |
| Placebo Twice Daily + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percentage of Subjects Achieving Pre-Specified Mean IOP: <=20 mmHg | 51 Participants |
| Placebo Twice Daily + Latanoprost | Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels | Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=20% | 53 Participants |