NCT04883996

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Canyon City Eyecare · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hyperopia
• Myopia

Interventions

Type	Name	Description
DRUG	1% EXP039	1% EXP039 (commercially available as Isopto® Carpine) contains 1% active ingredient (10 mg/mL),
OTHER	Saline control	Saline

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-07-31
• Completion: 2021-08-30
• First posted: 2021-05-12
• Last updated: 2021-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study