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

NCT04883996 | Unknown Phase 1 FDA Drug

• 1 other identifier: CP-EXP039-0001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperopia; Myopia

Keywords

Hyperopia; Myopia; Visual Acuity; Mesopic

Outcome Measures

Primary Outcomes (1)

• UDVA

  Mesopic high-contrast uncorrected distance visual acuity

  1 hour

Study Arms (2)

EXP039

ACTIVE COMPARATOR

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

Saline control

PLACEBO COMPARATOR

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

Interventions

1% EXP039 DRUG

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

Also known as: Isopto® Carpine

EXP039

Saline control OTHER

Saline

Also known as: Saline

Saline control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Canyon City Eyecare: lead
• Nevakar, Inc.: collaborator

Study Sites (1)

Canyon City Eyecare

Azusa, California, 91702, United States

Location

MeSH Terms

Conditions

Hyperopia; Myopia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Milton Hom, OD FAAO

  Canyon City Eyecare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 12, 2021
• Study Start: December 1, 2020
• Primary Completion: July 31, 2021
• Study Completion: August 30, 2021
• Last Updated: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)