Clinical trial NCT04883996: A Phase 1/2 Crossover Study to Assess EXP039 for Myopia or Hyperopia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hyperopia
Myopia
Keywords: Hyperopia
Myopia
Visual Acuity
Mesopic
Lead sponsor: Canyon City Eyecare
Sponsor class: OTHER
Collaborators: name: Nevakar, Inc.
First posted: 2021-05-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 to ≤80 years
2. 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
3. Low-to-moderate hyperopia (SER of +0.50D to +2.00D) or myopia (SER of -0.50 D to -4.00D) at Screening
4. Between-eye SER difference of no more than 0.50D
5. Best-corrected distance visual acuity better than or equal to 20/20 in both eyes at Screening
6. Astigmatism in each eye of less than or equal to 0.75D with manifest refraction at Screening
7. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at Screening
8. 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.
9. Males must not donate sperm for at least 90 days after the last dose of study drug
10. Participants must have the ability and willingness to attend the necessary visits
11. 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:

1. 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
2. Moderate or severe dry eye as defined by corneal fluorescein staining score of ≥3 on Oxford scale at Screening
3. 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)
4. Narrow iridocorneal angles (Shaffer grade ≤2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy
5. Intraocular pressure (IOP) \<8 mmHg or \>23 mmHg in either eye or history of glaucoma or ocular hypertension
6. Any clinically significant abnormal lens finding (e.g., cataract, loose zonules, exfoliation, pseudoexfoliation)
7. History of any intraocular surgery including cataract surgery or phakic intraocular lens surgery
8. 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
9. 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
10. Clinically significant strabismus or diplopia
11. History of stereo vision difficulties
12. History of optic neuropathy or amblyopia in either eye
13. Use of orthokeratology contact lenses within the past 1 month prior to EXP039 dosing on Day 1
14. Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes
15. Planned use of any contact lenses during the study
16. Allergy to pilocarpine or any of its excipients
17. Serious systemic illness that, in the opinion of the Investigator's, would render the participant ineligible
18. Pre-planned hospitalization or ocular or systemic surgery during the study period
19. 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
20. 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
21. Unwilling or unable to complete study procedures or to be followed up for the duration of the study

Primary outcomes:
measure: UDVA
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Azusa
country: United States
facility: Canyon City Eyecare
state: California
Study officials:
affiliation: Canyon City Eyecare
name: Milton Hom, OD FAAO
role: PRINCIPAL_INVESTIGATOR
References: