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Epi-On Corneal Crosslinking for Keratoconus

NCT03245853 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-01-28

No results posted yet for this study

Summary

Epithelium-On Corneal Crosslinking for Keratoconus.

Conditions

  • Keratoconus
  • Keratoconus, Unstable

Interventions

DRUG

Riboflavin 5'-Phosphate

Photrexa (riboflavin 5'-phosphate ophthalmic solution) 0.146%, is a yellow sterile buffered solution containing 1.46 mg/mL riboflavin 5'-phosphate, The pH of the solution is approximately 7.1 and the osmolarity is 157-177 mOsm/kg. Each 1 mL of the solution contains 1.53 mg of riboflavin 5'-phosphate sodium (equivilant to 1.20 mg \[0.12%\] riboflavin). Riboflavin 5'-phosphate sodium USP is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are dibasic sodium phosphate, monbasic sodium phosphate, sodium chloride, and water for injection.

Sponsors & Collaborators

  • Glaukos Corporation

    collaborator INDUSTRY

  • Comprehensive EyeCare of Central Ohio

    lead OTHER

Principal Investigators

  • Kenneth A Beckman, M.D. · Comprehensive EyeCare of Central Ohio

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-18
Primary Completion
2019-09-01
Completion
2019-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03245853 on ClinicalTrials.gov