Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

There is no standard of care medication regimen for the management of pain and inflammation post-corneal crosslinking (CXL), although most cornea specialists agree on use of an antibiotic and steroid eye drop in the immediate postoperative period. However, steroid tapering schedule and use of additional topical non-steroidal anti-inflammatory (NSAID) eyedrops vary amongst practitioners. The goal of this study is to compare postoperative pain scores between patients receiving a tapering dose of topical steroids over 1-month post-CXL, versus those receiving an intracanalicular dexamethasone insert.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sight Medical Doctors PLLC
• Collaborator: Ocular Therapeutix, Inc.
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Progressive keratoconus with planned corneal cross-linking in one or both eyes

• Age 18 years and older

• Ability to provide informed consent for procedures

• Ability to attend scheduled follow up visits

Exclusion Criteria:

• Age less than 18

• Pregnancy/currently breast-feeding

• Inability to provide informed consent

• Documented adverse reaction to steroid (e.g. "steroid responder", allergy, etc)

• Punctal stenosis

• Previous corneal transplant surgery

• Systemic concomitant use of controlled substance for pain management (i.e. oxycodone)

• Concurrent use of topical steroid eye drops

• Systemic, topical or intravitreal steroid use within 1 month of baseline

• Active history of chronic or recurrent inflammatory eye disease in either eye

• History of ocular herpetic infection (inclusive of Herpes Simplex 1/2, Varicella Zoster, Epstein Barr, Cytomegalovirus)

• History of neurotrophic keratitis, uncontrolled diabetes, or other disease entities that may preclude proper healing