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

PHASE3TerminatedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

August 31, 2008

Study Completion Date

January 31, 2010

Conditions
Corneal TransplantationCorneal 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

Trial Locations (30)

10003

New York Eye and Ear Infirmary, New York

10029

Mount Sinai School of Medicine, New York

11570

Ophthalmic Consultants of Long Island, Rockville Centre

12159

Cornea Consultants of Albany, Slingerlands

21218

The Eye Center at Union Memorial Hospital, Baltimore

21287

Wilmer Eye Institute, Cornea Service, Baltimore

23502

Virginia Eye Consultants, Norfolk

24105

Klinik fuer Ophthalmologie Campus Kiel, Kiel

27705

Duke University Eye Center, Durham

30322

Emory Eye Center, Atlanta

33136

Bascom Palmer Eye Institute, Miami

44106

University Hospitals Case Medical Center, Cleveland

45122

Cornea Bank, Universitätsklinikum Essen, Essen

46260

Price Vision Group, Indianapolis

48105

W.K. Kellogg Eye Center - University of Michigan, Ann Arbor

55431

MN Eye Consultants, P.A., Bloomington

60612

University of Illinois at Chicago, Chicago

63141

Ophthalmology Associates, St Louis

64111

Tauber Eye Center, Kansas City

75231

Cornea Associates of Texas, Dallas

80336

Ludwig Maximilians Universität, München

81675

Augenklinik der Technischen Universität München, München

85032

Cornea Consultants of Arizona, Phoenix

90033

USC Doheny Eye Institute, Los Angeles

91054

Augenklinik, Universitat Erlangen-Nurnberg, Erlangen

92354

Loma Linda University Health Care, Loma Linda

97080

Augenklinik Wuerzburg, Würzburg

98104

Eye Associates NW, Seattle

02111

New England Eye Center, Boston

07103

UMDNJ - New Jersey Medical School Institute of Ophthalmology and Visual Science, Newark

Sponsors
All Listed Sponsors
lead

Lux Biosciences, Inc.

INDUSTRY