Trial Information

Summary: This study may show that diabetics undergoing eye surgery (vitrectomy) with large corneal wounds may heal faster with this medication.

In diabetics who are having eye surgery (vitrectomy), corneal wounds may continue and do not necessarily respond to standard treatment because of delayed wound healing. While wound healing should occur following surgery to the cornea, it is usually slower in diabetics and it would be better if the wound heals faster. Wound healing not only protects the eye from infection, it is important for preventing corneal weakness that can lead to recurrent wounds or decreased vision.

The cornea wound repair process is very complex and must be properly followed by your doctor to ensure that the wound heals and the best visual result is achieved. Because patients with Diabetic Retinopathy corneas have slower wound healing, the use of this drug as a potent stimulator was investigated. Diabetic corneas were examined and were found to show less Tß4 compared to normal corneas which suggests that its use may speed up the wound-healing process.

Inclusion Criteria
Patients will be enrolled in this study only if they meet all of the following criteria:

• Male or female, aged 18 years and older.
• Type 1 or Type 2 diabetes mellitus.
• In the opinion of the Investigator at least a 50% likelihood of requiring corneal epithelial debridement during vitrectomy. Lensectomy concomitant with corneal epithelial debridement is permitted.
• Signed written informed consent by patient or legal guardian.

Exclusion Criteria
Patients will be enrolled in this study only if they meet none of the following criteria:

• Current herpetic eye disease or history thereof in the past 3 years.
• Evidence of keratitis.
• Sjögren’s dry eye syndrome.
• Corneal scarring, opacity, or dystrophy.
• History of malignancy.
• History of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).
• Pregnancy or lactation.
• Allergy to fluoroquinolones.
• Known hypersensitivity to the study drug or any of its formulaic ingredients.
• Previous participation in this study.
• Experience any complication during the surgical procedure itself, which excludes the patient from continued participation in this study.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.