The Role of Antioxidant Supplementation in Keratoconus Patients

Keratoconus Clinical Trial

Official title:

The Role of Antioxidants in Keratoconus Patients-A Randomized Controlled Trial of Oral Supplementation of Glutathione, Vitamin A, Vitamin C and Vitamin E

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02827747
• Other study ID #: 20150646
• Status: Withdrawn
• Phase: Phase 2
• Start date: August 1, 2021
• Est. completion date: March 2023

Study information

• Verified date: August 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Keratoconus is the most common primary cornea ectasia, where the cornea undergoes structural changes, leading to loss of tissue integrity and vision loss. The prevalence of Keratoconus is 1:2000 in the general population. Oxidative stress has been thought to have a major effect in the disease pathogenesis of Keratoconus. In vitro studies have shown increase in metabolites related to oxidative stress in Keratoconus disease, and that Keratoconus cells undergo increased oxidative stress and tissue damage. Animal models have shown a therapeutic effect of Vitamin C (ascorbate) in corneal wound healing. Glutathione and Vitamins A, C, and E are important antioxidants in the human body. To this date, the role of systemic antioxidant supplementation in Keratoconus patients has yet to be studied. In addition, it has yet to be established as to whether there is a correlation between serum antioxidant levels, and the severity of disease in the Keratoconus patient. The investigators propose to investigate the plasma levels of antioxidants in relation to disease severity. The investigators will also investigate the role of antioxidant supplementation-consisting of parenteral Glutathione (GSH), and Vitamins A, C and E-in delaying the disease progression in Keratoconus.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2023
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Participants would be without illness or condition that could make follow-up, or compliance with study medication difficult.

• Participants may have a prior diagnosis of Keratoconus, or may be diagnosed at the initial visit.

• Participants should not have an eye diagnosis, other than Keratoconus, that could adversely influence the visual acuity.

• These participants must not have had prior surgical procedure to treat Keratoconus, including collagen cross-linking, Intacs ring segments, or corneal transplantation.

Exclusion Criteria:

• would exclude smokers and former-smokers.

Related Conditions & MeSH terms

• Keratoconus

Intervention

Other:
• Antioxidants (Vitamins A,C,E) plus GSH
Study medication would contain 500 milligrams of vitamin C, 400 International Units of vitamin E, and 15 milligrams of beta-carotene (the equivalent to 25,000 International Units of vitamin A).The study medication would also contain 1000mg of Glutathione (GSH).
• Placebo
Placebo pill

Dietary Supplement:
• Centrum
Centrum

Combination Product:
• Dietary Sources
From dietary sources of vitamins.

Locations

Country	Name	City	State
United States	Bascom Palmer Eye Institute-- Palm Beach Gardens	Palm Beach Gardens	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Fight for Sight

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visual Acuity Measured by Snellen Chart		Baseline to 24 months
Secondary	Change in cornea thickness as measured by video keratography		Baseline to 24 months
Secondary	Plasma level of Vitamin A	Blood draws to look at plasma level of Vitamin A	Baseline to 24 months
Secondary	Plasma level of Vitamin C	Blood draws to look at plasma level of Vitamin C	Baseline to 24 months
Secondary	Plasma level of Vitamin E	Blood draws to look at plasma level of Vitamin E	Baseline to 24 months
Secondary	Plasma level of Glutathione (GSH)	Blood draws to look at plasma level of GSH	Baseline to 24 months