A Phase 1/2, Randomized, Placebo Controlled Crossover Study to Assess the Safety, Pharmacodynamics, and Efficacy of EXP039 Ophthalmic Solution in Participants With Myopia or Hyperopia

Canyon City Eyecare1 site in 1 country60 target enrollmentDecember 1, 2020

ConditionsHyperopia Myopia

Interventions1% EXP039 Saline control

Drugs1% EXP039

Overview

Phase: Phase 1
Intervention: 1% EXP039
Conditions: Hyperopia
Sponsor: Canyon City Eyecare
Enrollment: 60
Locations: 1
Primary Endpoint: UDVA
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Assess the Safety, Pharmacodynamics, and Efficacy of EXP039 Ophthalmic Solution in Participants with Myopia or Hyperopia

Detailed Description

To characterize the effect of pupillary miosis as achieved with EXP039 1% ophthalmic solution in terms of mean number of lines (Early Treatment Diabetic Retinopathy Study \[ETDRS\]) of improvement from baseline in binocular (both eyes open) mesopic high-contrast uncorrected distance visual acuity (UDVA) at 1-hour post treatment.

Registry

clinicaltrials.gov

Start Date

December 1, 2020

End Date

August 30, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Canyon City Eyecare

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18 to ≤80 years
•Participants must be in good general health, with no significant medical problems that, in the opinion of the investigator, would preclude participation in the trial, at Screening and/or before administration of the dose of study drug
•Low-to-moderate hyperopia (SER of +0.50D to +2.00D) or myopia (SER of -0.50 D to -4.00D) at Screening
•Between-eye SER difference of no more than 0.50D
•Best-corrected distance visual acuity better than or equal to 20/20 in both eyes at Screening
•Astigmatism in each eye of less than or equal to 0.75D with manifest refraction at Screening
•Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at Screening
•WOCBP must be non-pregnant and non-lactating, and must use a medically approved, highly effective contraception method from Screening until study completion, including the follow up period. Female participants who are in same sex relationships are not required to use contraception.Males must be surgically sterile (\>30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a WOCBP, the participant and his partner must use a medically approved, highly effective contraceptive method from Screening until study completion, including the follow-up period.
•Males must not donate sperm for at least 90 days after the last dose of study drug
•Participants must have the ability and willingness to attend the necessary visits

Exclusion Criteria

•Any central corneal abnormality (e.g., keratoconus, Pellucid marginal degeneration, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that is likely to interfere with visual acuity
•Moderate or severe dry eye as defined by corneal fluorescein staining score of ≥3 on Oxford scale at Screening
•Any clinically significant pupillary or iris abnormality (e.g., anisocoria of \>1 mm between eyes at Screening or baseline, abnormal pupil shape in either eye, iris transillumination defects, or any congenital or traumatic defect of the iris)
•Narrow iridocorneal angles (Shaffer grade ≤2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy
•Intraocular pressure (IOP) \<8 mmHg or \>23 mmHg in either eye or history of glaucoma or ocular hypertension
•Any clinically significant abnormal lens finding (e.g., cataract, loose zonules, exfoliation, pseudoexfoliation)
•History of any intraocular surgery including cataract surgery or phakic intraocular lens surgery
•History in either eye of previous corneal inlay, full- or partial-thickness corneal transplant, radial keratotomy or any corneal surgery including laser-based corneal refractive surgery
•Any clinically significant abnormal finding on dilated fundus examination in either eye or known history of retinal detachment, retinal trauma, retinal or vitreal surgery, or clinically significant retinal disease in either eye
•Clinically significant strabismus or diplopia

Arms & Interventions

EXP039

At Visit 1, single dose 1 drop of EXP039 1% is adminstered, followed by washout period of 1-10 days. Subsequently, subjects will crossover to single dose 1 drop saline at Visit 2.

Intervention: 1% EXP039

Saline control

At Visit 1, single dose 1 drop of saline is adminstered, followed by washout period of 1-10 days. Subsequently, subjects will crossover to single dose 1 drop EXP039 1% at Visit 2.

Intervention: Saline control