MedTrace Logo

Study to Assess LX201 for Prevention of Corneal Allograft Rejection or Graft Failure in Subjects Who Have Experienced One or More Rejection Episodes Following Penetrating Keratoplasty

NCT00447642 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2012-10-11

No results posted yet for this study

Summary

This study will evaluate the use of LX201 to prevent future graft rejection episodes and/or graft failure in patients who have undergone corneal transplantation and who have recently experienced a rejection episode due to an immune response.

Conditions

  • Corneal Transplantation
  • Corneal Graft Rejection

Interventions

DRUG

LX201

LX201 was a novel sustained-release silicone implant containing 30% cyclosporine A by weight. LX201 was available in two different lengths, 0.50 and 0.75 inch. Each implant is 0.08 inch wide and 0.04 inch in height. The implants are flat on one side (the posterior surface, which is applied to the episclera) and the anterior surface and ends were rounded.

OTHER

Placebo

The placebo was a silicone implant 0.75 inch in length. It contained no cyclosporine A

Sponsors & Collaborators

  • Lux Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Eddy Anglade, MD · Chief Medical Officer, Lux Biosciences, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-08-31
Completion
2010-01-31

Countries

  • United States
  • Germany

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 NCT00447642 on ClinicalTrials.gov