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

Sponsor

Aerpio Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT04405245

Collaborator

(none)

194

Enrollment

Locations

Arms

Actual Duration (Months)

9.2

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Hypertension Primary Open Angle Glaucoma	Drug: Latanoprost ophthalmic solution Drug: AKB-9778 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

194 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Phase 2 Multi-Center, Double-Masked, Randomized, 28-Day Study to Assess the Efficacy, Safety and Tolerability of Single or Twice Daily Doses of AKB-9778 Ophthalmic Solution as an Adjunct to Latanoprost in Patients With Ocular Hypertension (OHT) or Open Angle Glaucoma (OAG)

Actual Study Start Date :

Jun 6, 2020

Actual Primary Completion Date :

Nov 5, 2020

Actual Study Completion Date :

Nov 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AKB-9778 QD + Latanoprost • AKB-9778 QD (AM) and placebo for AKB-9778 ophthalmic solution QD (PM) plus latanoprost QD (PM) for 28 days	Drug: Latanoprost ophthalmic solution Latanoprost opthalmic solution to be dosed once daily Drug: AKB-9778 AKB-9778 opthalmic solution
Experimental: AKB-9778 BID + Latanoprost • AKB-9778 BID (AM & PM) plus latanoprost QD (PM) for 28 days	Drug: Latanoprost ophthalmic solution Latanoprost opthalmic solution to be dosed once daily Drug: AKB-9778 AKB-9778 opthalmic solution
Placebo Comparator: Placebo BID + Latanoprost • Placebo for AKB-9778 ophthalmic solution BID (AM & PM) plus latanoprost QD (PM) for 28 days	Drug: Latanoprost ophthalmic solution Latanoprost opthalmic solution to be dosed once daily Drug: Placebo placebo for AKB-9778 opthalmic solution

Arm

Intervention/Treatment

Experimental: AKB-9778 QD + Latanoprost

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

Drug: Latanoprost ophthalmic solution

Latanoprost opthalmic solution to be dosed once daily

Drug: AKB-9778

AKB-9778 opthalmic solution

Experimental: AKB-9778 BID + Latanoprost

• AKB-9778 BID (AM & PM) plus latanoprost QD (PM) for 28 days

Drug: Latanoprost ophthalmic solution

Latanoprost opthalmic solution to be dosed once daily

Drug: AKB-9778

AKB-9778 opthalmic solution

Placebo Comparator: Placebo BID + Latanoprost

• Placebo for AKB-9778 ophthalmic solution BID (AM & PM) plus latanoprost QD (PM) for 28 days

Drug: Latanoprost ophthalmic solution

Latanoprost opthalmic solution to be dosed once daily

Drug: Placebo

placebo for AKB-9778 opthalmic solution

Outcome Measures

Primary Outcome Measures

Intraocular pressure [Baseline to Day 28]
Intraocular pressure in mmHg

Secondary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Baseline to Day 28]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	United Medical Research Institute	Inglewood	California	United States	90301
2	North Valley Eye Medical Group	Mission Hills	California	United States	91345
3	Eye Research Foundation	Newport Beach	California	United States	92663
4	North Bay Eye Associates	Petaluma	California	United States	94954
5	Shettle Eye Research	Largo	Florida	United States	33773
6	Clayton Eye Clinical Research, LLC	Morrow	Georgia	United States	30260
7	Coastal Research Associates	Roswell	Georgia	United States	30076
8	Kannarr Eye Care	Pittsburg	Kansas	United States	66762
9	Heart of America Eye Care, P.A.	Shawnee Mission	Kansas	United States	66204
10	Tekwani Vision Center	Saint Louis	Missouri	United States	63128
11	North Valley Eye Medical Group	Rochester	New York	United States	14618
12	Charlotte Eye, Ear, Nose & Throat Assoc. (CEENTA)	Charlotte	North Carolina	United States	28210
13	James D. Branch, MD Ophthalmology	Winston-Salem	North Carolina	United States	27101
14	Apex Eye	Cincinnati	Ohio	United States	45242
15	Abrams Eye Center	Cleveland	Ohio	United States	44115
16	Mark J. Weiss, MD, Inc.	Tulsa	Oklahoma	United States	74104
17	Scott & Christie and Assoc	Cranberry Township	Pennsylvania	United States	16066
18	Eye Care Specialists	Kingston	Pennsylvania	United States	18704
19	Total Eye Care	Memphis	Tennessee	United States	38119
20	Advancing Vision Research	Nashville	Tennessee	United States	37205
21	Texan Eye / Keystone Research	Austin	Texas	United States	78731