The Role of Antioxidant Supplementation in Keratoconus Patients

NCT02827747 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 20150646
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Keratoconus

Keywords

Keratoconus progression; Vitamins and keratoconus; Vitamin supplementation

Outcome Measures

Primary Outcomes (1)

• Change in Visual Acuity Measured by Snellen Chart

  Baseline to 24 months

Secondary Outcomes (5)

• Change in cornea thickness as measured by video keratography

  Baseline to 24 months

• Plasma level of Vitamin A

  Baseline to 24 months

• Plasma level of Vitamin C

  Baseline to 24 months

• Plasma level of Vitamin E

  Baseline to 24 months

• Plasma level of Glutathione (GSH)

  Baseline to 24 months

Study Arms (4)

Placebo with Dietary Sources of Vitamins

PLACEBO COMPARATOR

Persons assigned to placebo, who obtain Vitamins A, C, E and Glutathione from dietary sources alone, and have not been on oral RDA supplementation, in the 1 month leading up the time of enrollment and throughout the study period.

Other: Placebo; Combination Product: Dietary Sources

Antioxidants(Vitamins A,C,E) plus GSH, plus Centrum

ACTIVE COMPARATOR

Persons assigned to the study medication, and are continuing the take an oral RDA supplementation, in the form of Centrum.

Other: Antioxidants (Vitamins A,C,E) plus GSH; Dietary Supplement: Centrum

Antioxidants (Vitamins A,C, E) plus GSH

ACTIVE COMPARATOR

Persons assigned to the study medication alone, without oral RDA supplementation in the 1 month leading up the time of enrollment and throughout the study period.

Other: Antioxidants (Vitamins A,C,E) plus GSH

Placebo plus Centrum

ACTIVE COMPARATOR

Persons assigned to placebo, who have been on oral RDA supplementation, who would continue to do so throughout the study.

Other: Placebo; Dietary Supplement: Centrum

Interventions

Antioxidants (Vitamins A,C,E) plus GSH OTHER

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).

Antioxidants (Vitamins A,C, E) plus GSH; Antioxidants(Vitamins A,C,E) plus GSH, plus Centrum

Placebo OTHER

Placebo pill

Placebo plus Centrum; Placebo with Dietary Sources of Vitamins

Centrum DIETARY_SUPPLEMENT

Centrum

Antioxidants(Vitamins A,C,E) plus GSH, plus Centrum; Placebo plus Centrum

Dietary Sources COMBINATION_PRODUCT

From dietary sources of vitamins.

Placebo with Dietary Sources of Vitamins

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• would exclude smokers and former-smokers.

Sponsors & Collaborators

• University of Miami: lead
• Fight for Sight: collaborator

Study Sites (1)

Bascom Palmer Eye Institute-- Palm Beach Gardens

Palm Beach Gardens, Florida, 33418, United States

Location

MeSH Terms

Conditions

Keratoconus

Interventions

Antioxidants

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals

Study Officials

• Ellen Koo, M.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: July 11, 2016
• Study Start: August 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: March 1, 2023
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)