Clinical Trials Directory

Trials / Terminated

TerminatedNCT01189864

Cross-linking of Corneal Collagen (CXL) With Ultraviolet-A in Asymmetric Corneas

Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Status
Terminated
Phase
Study type
Observational
Enrollment
3,493 (actual)
Sponsor
Cxlusa · Industry
Sex
All
Age
12 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication. The data generated by this study will not be submitted to the FDA to support commercialization of these riboflavin drops.

Conditions

Interventions

TypeNameDescription
DRUGCiprofloxicin or Vigamox or other.Ciprofloxicin or Vigamox or other to be used qid till epithelialized.
DRUGNonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc)Nonsteroidal (Acular, Voltaren Xibrom, etc) qid up to 5-10 days post-op
DRUGSteroid (FML, Pred Forte, Flarex, etc.)Steroid (FML, Pred Forte, Flarex, etc.) to be used qid to qd for 1-8 weeks.

Timeline

Start date
2010-02-01
Primary completion
2017-02-03
Completion
2017-02-03
First posted
2010-08-27
Last updated
2018-10-12

Locations

16 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01189864. Inclusion in this directory is not an endorsement.