Status:
COMPLETED
Safety and Preliminary Efficacy of IVMED-80 Eye Drops in Keratoconus Patients
Lead Sponsor:
iVeena Delivery Systems, Inc.
Collaborating Sponsors:
Codet Vision Institute
Conditions:
Keratoconus
Corneal Ectasia
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
PHASE2
Brief Summary
We investigated the use of a copper sulfate eye drop (IVMED-80) for the treatment of keratoconus. Preliminary laboratory data shows that the addition of copper sulfate increase crosslinking of the str...
Detailed Description
Standard Operating Procedures: This study was designed to evaluate the safety and preliminary efficacy of IVMED-80 (0.15 mg/mL copper sulfate pentahydrate) in controlling the progression of corneal c...
Eligibility Criteria
Inclusion
- Mild to moderate keratoconus and/or corneal ectasia post-LASIK or Photo-Refractive Keratectomy
- Age 18 to 40
- Minimum corneal thickness of \> 350 microns
- Maximum corneal keratometry of 45 D to 67 D
- Absence of systemic comorbidities that pose a significant surgical risk
- Absence of ocular comorbidities
- Willing and able to comply with clinic visits and study-related procedures.
- Provide signed informed consent
Exclusion
- Significant central corneal scarring or hydrops
- Previous corneal surgeries
- Presence of pre-existing glaucoma, uveitis, uncontrolled diabetic retinopathy, or prior ocular trauma or prior intraocular surgery.
- Myopic degeneration with potential acuity less than 20/40 in the Study Eye.
- Down's Syndrome, retinitis pigmentosa, Ehlers-Danlos Syndrome, osteogenesis imperfecta (or other collagen disorder) or Anton's Syndrome.
- Prior retinal detachment involving the macula
- Received a sub-Tenon's injection of corticosteroid within the past 6 months, or any intravitreal injection within the past 6 months in the study eye prior to Visit 1
- Current use, or anticipated initiation during the study, of a systemic corticosteroid or an immunosuppressant agent by any route (oral, injectables)
- History or current condition of substance or alcohol abuse within the past year
- Participation in a clinical trial with use of any investigational drug or treatment within 30 days prior to Visit 1
- Employee of the study site or their immediate families.
- Pregnancy or planning to become pregnant.
Key Trial Info
Start Date :
February 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2020
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05241145
Start Date
February 8 2019
End Date
July 8 2020
Last Update
February 15 2022
Active Locations (1)
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1
Codet Vision Institute
Tijuana, Estado de Baja California, Mexico, 22320