Phase 2
N=194
Study to Assess the Efficacy, Safety and Tolerability of AKB-9778 Ophthalmic Solution as and Adjunct to Latanoprost in Patients With Ocular Hypertension or Open Angle Glaucoma
Ocular Hypertension · Primary Open Angle Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT04405245 ↗Enrolled (actual)
194
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Change From Baseline in Intraocular Pressure at Day 28 (Study Eye) — -6.95; -7.95; -7.04 mmHg — p=0.8070
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Latanoprost ophthalmic solution (Drug); AKB-9778 4% (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- EyePoint Pharmaceuticals, Inc.
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Intraocular Pressure at Day 28 (Study Eye) |
-6.95; -7.95; -7.04 | 0.8070 |
| SECONDARY Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye) |
-6.75; -7.62; -7.03 | — |
| SECONDARY Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes) |
-6.68; -7.53; -6.91; -6.83; -7.86; -6.93 | — |
| SECONDARY Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes) |
18.01; 17.37; 17.95; 17.86; 17.03; 17.92 | — |
| SECONDARY Mean Observed IOP at Each Time Point on Days 14 and 28 |
19.54; 18.25; 18.75; 17.98; 17.32; 18.02 | — |
| SECONDARY Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 |
-6.66; -8.13; -7.59; -7.02; -7.88; -7.45 | — |
| SECONDARY Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 |
-25.52; -30.41; -28.68; -28.09; -31.10; -29.29 | — |
| SECONDARY Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28 |
-27.08; -30.29; -28.16; -27.83; -31.67; -28.19 | — |
| SECONDARY Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels |
60; 63; 58; 56; 60; 51 | — |
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.
Eligibility 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 0.8 in either eye
- Severe visual field defect or significant defect (sensitivity of ≤ 10dB) within 10 degrees of fixation in either eye
Data sourced from ClinicalTrials.gov (NCT04405245). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.