A Phase 1/2 Crossover Study to Assess EXP039 for Myopia or Hyperopia

Sponsor

Canyon City Eyecare (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04883996

Collaborator

Nevakar, Inc. (Industry)

Enrollment

Location

Arms

8.9

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hyperopia Myopia	Drug: 1% EXP039 Other: Saline control	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Jul 31, 2021

Anticipated Study Completion Date :

Aug 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: 1% EXP039 1% EXP039 (commercially available as Isopto® Carpine) contains 1% active ingredient (10 mg/mL), Other Names: Isopto® Carpine
Placebo Comparator: 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.	Other: Saline control Saline Other Names: Saline

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: 1% EXP039

1% EXP039 (commercially available as Isopto® Carpine) contains 1% active ingredient (10 mg/mL),

Other Names:

Isopto® Carpine

Placebo Comparator: 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.

Other: Saline control

Saline

Other Names:

Saline

Outcome Measures

Primary Outcome Measures

UDVA [1 hour]
Mesopic high-contrast uncorrected distance visual acuity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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
Participants must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.

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
History of stereo vision difficulties
History of optic neuropathy or amblyopia in either eye
Use of orthokeratology contact lenses within the past 1 month prior to EXP039 dosing on Day 1
Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes
Planned use of any contact lenses during the study
Allergy to pilocarpine or any of its excipients
Serious systemic illness that, in the opinion of the Investigator's, would render the participant ineligible
Pre-planned hospitalization or ocular or systemic surgery during the study period
History of any substance abuse (alcohol and/or illegal drugs) and not willing to abstain from drug(s) and reasonably limit alcohol consumption to approximately 2 alcoholic beverages per day during the 30-day study period
Participation in any other study of investigational therapy during the study period or within the last 30 days or 5 half-lives, whichever is longer
Unwilling or unable to complete study procedures or to be followed up for the duration of the study