Safety and Preliminary Efficacy of IVMED-80 Eye Drops in Keratoconus Patients

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

February 8, 2019

Primary Completion Date

July 8, 2020

Study Completion Date

July 8, 2020

Conditions
KeratoconusCorneal Ectasia
Interventions
DRUG

IVMED-80

Good Manufacturing Practices-grade copper (ІІ) sulfate pentahydrate (CuSO4 #5H2O MW 249.69) was dissolved in a vehicle solution comprised of a balanced salt solution (BSS) with osmolality of approximately 500 mOsm/L. Copper sulfate was concentrated to 0.15 mg/mL. The drops were manufactured on prior to the study at a compounding pharmacy in Salt Lake City, Utah.

OTHER

Placebo

This was identical to the IVMED-80 product, but without the active ingredient, copper sulfate.

Trial Locations (1)

22320

Codet Vision Institute, Tijuana

All Listed Sponsors
collaborator

Codet Vision Institute

OTHER

lead

iVeena Delivery Systems, Inc.

INDUSTRY

NCT05241145 - Safety and Preliminary Efficacy of IVMED-80 Eye Drops in Keratoconus Patients | Biotech Hunter | Biotech Hunter