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NCT04897503: CXL
Randomized Study of Safety and Effectiveness of Corneal Collagen Crosslinking Using Riboflavin/Dextran or Riboflavin/Methylcellulose
Phase 3 trial testing Riboflavin in Keratoconus in 170 participants. Status unknown.
1 June 2025
Quick facts
| Lead sponsor | Cornea and Laser Eye Institute |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 170 |
| Start date | 16 April 2021 |
| Primary completion | 1 June 2025 |
| Estimated completion | 1 December 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Riboflavin (RIBOFLAVIN) — full drug profile →
Conditions studied
- Keratoconus — all drugs for Keratoconus →
- Corneal Ectasia — all drugs for Corneal Ectasia →
Sponsor
Cornea and Laser Eye Institute
Who can join
12 and older, any sex, with Keratoconus or Corneal Ectasia. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Maximum keratometry
Time frame: 12 months
The change in maximum keratometry (Kmax) from baseline will be evaluated at 12 months for all eyes randomized in group 1 and group 2.
Sponsor's own description
This study is being conducted to evaluate the safety and efficacy of isotonic riboflavin for corneal collagen crosslinking for keratoconus and corneal ectasia. will determine the safety and efficacy of corneal collagen crosslinking (CXL) performed with two different riboflavin formulations for reducing corneal curvature.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04897503
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Riboflavin
Trials testing the same drug.
- NCT05907850 — Effects of Riboflavin in Mitigating Muscle Soreness in Ultra-marathon Athletes · EARLY_PHASE1 · completed
- NCT05803811 — Effect of Colon Delivered Vitamin B2 on Gut Microbiota and Related Health Biomarkers in Healthy Older Adults · NA · completed
- NCT04232800 — Riboflavin for Glutamate Reduction in Alcohol Withdrawal · Phase 2 · unknown
- NCT03432572 — Investigating Oral Agents for Urine Staining to Facilitate Intraoperative Observation of Ureteral Jets · EARLY_PHASE1 · completed
- NCT03151096 — Pilot Evaluation of the Effect of Riboflavin Supplementation on Blood Pressure and Possible Effect Modification by the M · NA · terminated
Other recruiting trials for Keratoconus
Currently open trials in the same condition.
- NCT07372911 — PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus · NA · recruiting
- NCT07461129 — Electrophysiological Changes in Cases of Different Stages of Keratoconus · active not recruiting
- NCT06601101 — Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus · Phase 3 · recruiting
- NCT05516004 — Safety and Effectiveness of the PXL-Platinum 330 System for Cornea Crosslinking in Eyes With Cornea Thinning · Phase 2 · recruiting
- NCT06798779 — Predicting Manifest Astigmatism in Keratoconus Patients. · active not recruiting
Other Cornea and Laser Eye Institute trials
Trials by the same sponsor.
- NCT04895514 — Gamma-Irradiated Corneal Inlay for Keratoconus · NA · unknown
- NCT04698590 — Wavefront Guided Scleral Lenses for Keratoconus and Irregular Astigmatism · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04897503 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cornea and Laser Eye Institute
- Last refreshed: 30 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04897503.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing