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

EyePoint Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Ocular Hypertension; Primary Open Angle Glaucoma

Treatments: Drug: Latanoprost ophthalmic solution; Drug: AKB-9778 4%; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04405245

AKB-9778-CI-OS-2001

Details and patient eligibility

About

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.

Enrollment: 194 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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194 participants in 3 patient groups, including a placebo group

AKB-9778 4% QD + Latanoprost

Experimental group

Description:

• AKB-9778 4% daily (AM) and placebo for ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days

Treatment:

Drug: AKB-9778 4%

Drug: Latanoprost ophthalmic solution

AKB-9778 4% BID + Latanoprost

Experimental group

Description:

• AKB-9778 4% twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days

Treatment:

Drug: AKB-9778 4%

Drug: Latanoprost ophthalmic solution

Placebo Twice Daily + Latanoprost

Placebo Comparator group

Description:

• Placebo for AKB-9778 4% ophthalmic solution twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days

Treatment:

Drug: Placebo

Drug: Latanoprost ophthalmic solution