** FREE STUDY FOR PATIENTS WITH KERATOCONUS **
EPITHELIUM-ON CROSS -LINKING STUDY FOR KERATOCONUS
Ovette Villavicencio, M.D., PhD
Study Coordinator: Susana Flores
Phone number: 520-576-5110 Fax number: 520-529-7165
Catalina Eye Care is participating in an exciting clinical trial studying the safety and effectiveness of investigational
epithelium-on cross-linking for keratoconus in individuals 8 to 45 years of age. This unique randomized,
double-masked, sham-controlled, phase 3 study allows both study treatment on initial diagnosis and
bilateral simultaneous study treatment on qualified eyes.
Corneal cross-linking (CXL) has been shown to halt or slow the progression of keratoconus. This
procedure provides a method of stiffening the cornea to prevent or slow the progression of ectatic
disease.
As opposed to the currently available cross-linking, which requires removal of the corneal
epithelium and delaying treatment until the disease progresses, our study does not require epithelial
removal and offers study treatment upon initial diagnosis for qualified eyes.
The study will enroll 400 participants with a clinical diagnosis of keratoconus confirmed by tomographic
imaging. The efficacy and safety will be evaluated versus controlled matching sham to determine whether
the investigational procedure can increase the level of vision as assessed by best spectacle-corrected
visual acuity. Study participants will be randomized equally to active versus sham study groups, but all
sham (placebo) participants will be offered active study treatment at the end of the trial or earlier if they
show a worsening of disease.
Study enrollment is currently active, and visits are conducted at our research location. There will be no
charge to study participants for their participation in this study. The investigational procedure, study –
related procedures, and study visits will be provided at no charge.
If you have a patient you think may qualify, please call my office at the number below. When referring a
patient to this study, please be assured that our involvement will be strictly study-related and the primary
care of the patient will remain unchanged.
If you have questions about this study, please do not hesitate to contact my office. Thank you for
your consideration.
Sincerely,
Ovette Villavicencio, M.D., PhD
Study Coordinator: Susana Flores
Phone number: 520-576-5110