KeratoconusPhase 2NCT02827747
The Role of Antioxidant Supplementation in Keratoconus Patients
A Phase 2 study testing Antioxidants (Vitamins A,C,E) plus GSH, Centrum and Dietary Sources in people with Keratoconus, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- Antioxidants (Vitamins A,C,E) plus GSH, Centrum and Dietary Sources
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- would exclude smokers and former-smokers.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bascom Palmer Eye Institute-- Palm Beach Gardens
Palm Beach Gardens, Florida, 33418
About this study
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
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
- Being tested
- Antioxidants (Vitamins A,C,E) plus GSH, Placebo, Centrum, Dietary Sources
- Keywords
- Keratoconus progression, Vitamins and keratoconus, Vitamin supplementation
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antioxidants (Vitamins A,C,E) plus GSHOther
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).
PlaceboOther
Placebo pill
CentrumDietary supplement
Centrum
Dietary SourcesCombination product
From dietary sources of vitamins.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Placebo; Dietary Supplement: Centrum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Acuity Measured by Snellen Chart
Measured: Baseline to 24 months
Secondary outcomes (5)
Change in cornea thickness as measured by video keratography
Measured: Baseline to 24 months
Plasma level of Vitamin A
Blood draws to look at plasma level of Vitamin A
Measured: Baseline to 24 months
Plasma level of Vitamin C
Blood draws to look at plasma level of Vitamin C
Measured: Baseline to 24 months
Plasma level of Vitamin E
Blood draws to look at plasma level of Vitamin E
Measured: Baseline to 24 months
Plasma level of Glutathione (GSH)
Blood draws to look at plasma level of GSH
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start1 Aug 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionMar 2023 (estimated)
Why it stopped: Not enough participant interest.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Fight for Sight
- Responsible party
- Principal investigator, Ellen Koo, University of Miami
- Investigators
- Ellen Koo, M.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827747
- Sponsor's protocol ID
- 20150646
- Status last verified
- Aug 2021
- First submitted
- 25 Feb 2016
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02827747
- Acronym / sponsor ID
- 20150646
- Conditions
- Keratoconus
- Keywords
- Keratoconus progression, Vitamins and keratoconus, Vitamin supplementation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough participant interest.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Fight for Sight
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo with Dietary Sources of Vitamins | Placebo comparator | Other: Placebo, Combination Product: Dietary SourcesPersons 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. |
| Antioxidants(Vitamins A,C,E) plus GSH, plus Centrum | Active comparator | Other: Antioxidants (Vitamins A,C,E) plus GSH, Dietary Supplement: CentrumPersons assigned to the study medication, and are continuing the take an oral RDA supplementation, in the form of Centrum. |
| Antioxidants (Vitamins A,C, E) plus GSH | Active comparator | Other: Antioxidants (Vitamins A,C,E) plus GSHPersons 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. |
| Placebo plus Centrum | Active comparator | Other: Placebo, Dietary Supplement: CentrumPersons assigned to placebo, who have been on oral RDA supplementation, who would continue to do so throughout the study. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- would exclude smokers and former-smokers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antioxidants (Vitamins A,C,E) plus GSHStudy 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). | Other | Antioxidants (Vitamins A,C, E) plus GSH, Antioxidants(Vitamins A,C,E) plus GSH, plus Centrum |
| PlaceboPlacebo pill | Other | Placebo plus Centrum, Placebo with Dietary Sources of Vitamins |
| CentrumCentrum | Dietary supplement | Antioxidants(Vitamins A,C,E) plus GSH, plus Centrum, Placebo plus Centrum |
| Dietary SourcesFrom dietary sources of vitamins. | Combination product | Placebo with Dietary Sources of Vitamins |
Primary outcome
Change in Visual Acuity Measured by Snellen Chart
Time frame: Baseline to 24 months
5 secondary outcomes
Change in cornea thickness as measured by video keratography
Time frame: Baseline to 24 months
Plasma level of Vitamin A
Time frame: Baseline to 24 months
Plasma level of Vitamin C
Time frame: Baseline to 24 months
Plasma level of Vitamin E
Time frame: Baseline to 24 months
Plasma level of Glutathione (GSH)
Time frame: Baseline to 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Keratoconus
RecruitingObservational study
UNITY DX Cornea Study
Tomography
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Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Recruiting
Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
Keratoconus, Presbyopia
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
Enrolling by invitationObservational study
Corneal Biomechanical Analysis Using Brillouin Microscopy
Keratoconus, Keratoconus, Unstable
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Koo, M.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antioxidants (Vitamins A,C,E) plus GSH, Centrum and Dietary Sources in people with Keratoconus, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Acuity Measured by Snellen Chart (time frame: Baseline to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.