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

  • STATUS
    Recruiting
  • days left to enroll
    28
  • participants needed
    195
  • sponsor
    Aerpio Therapeutics
Updated on 23 August 2020
hypertension
prostaglandin
glaucoma
ophthalmic solution
latanoprost
ocular hypotensive
hypotensive
pigmentary glaucoma
latanoprost ophthalmic solution
akb-9778

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.

Details
Treatment Placebo, Latanoprost ophthalmic solution, AKB-9778
Clinical Study IdentifierNCT04405245
SponsorAerpio Therapeutics
Last Modified on23 August 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Eye Disorders/Infections (Pediatric) or Eye Disease or Glaucoma or Dry Eye Disease or Primary Open Angle Glaucoma or EYE DISORDER or Ocular Hypertensi...?
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

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
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