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Study to Assess the Efficacy and Safety of LX201 for Prevention of Corneal Allograft Rejection Episodes and Graft Failure in Subjects at Increased Immunological Risk

NCT00447187 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2012-10-11

No results posted yet for this study

Summary

This was a pivotal trial to determine whether LX201 reduces the likelihood of a graft rejection episode following corneal transplantation in patients at high immunological risk for rejection.

Conditions

  • Corneal Diseases
  • Cornea Transplant

Interventions

DRUG

LX201

LX201 is 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 was 0.08 inch wide and 0.04 inch in height. The implants were 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
2009-03-31
Completion
2010-11-30

Countries

  • United States
  • Germany

Study Locations

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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 NCT00447187 on ClinicalTrials.gov