Clinical trial NCT04168112: Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study
Official title: Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Keratoconus, Unstable
Collagen Crosslinking
Postoperative Pain
Keywords: Collagen Crosslinking
Keratoconus
Dexamethasone
Intracanalicular Insert
Lead sponsor: Sight Medical Doctors PLLC
Sponsor class: OTHER
Collaborators: name: Ocular Therapeutix, Inc.
First posted: 2019-11-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two cohorts of patients will be studied (10 patients each group). Cohort A: intracanalicular dexamethasone insert is placed on day of crosslinking (CXL); patients will still receive postoperative fluoroquinolone (or another class if allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye 4 times daily x 10 days).

Cohort B: Patients are placed on standard postoperative regimen of postoperative fluoroquinolone antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye 4 times daily (QID) x 10 days) and Prednisolone acetate 1% ophthalmic solution tapered over 1 month in the following schedule: 4 times daily x1 week, three times daily (TID) x 1 week, twice daily (BID) x 1 week, and once daily (QD) x 1 week).
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Keratoconus is a progressive ectatic disease of the cornea, leading to worsening of astigmatism and vision over time. With FDA approval of corneal collagen cross-linking (CXL), we now have the ability to halt the progression of keratoconus and prevent further vision loss in these patients. Although CXL has now become standard of care, the immediate post-operative period can be quite painful despite use of anti-inflammatory medications/eye drops. The goal of this study is to evaluate the efficacy of an intracanalicular dexamethasone insert in reduction of post-CXL pain as compared to routine steroid eye drop therapy.

To date, no studies have been performed evaluating the success of an intracanalicular dexamethasone insert for the treatment of postoperative inflammation and pain in corneal cross-linking patients. Oftentimes, patients experience a great deal of discomfort post-CXL, which may also make it difficult to apply eye drops in the correct fashion. Use of a dexamethasone insert alleviates the need for postoperative steroid eye drops and may provide increased pain relief post-CXL as compared to topical therapy. This will be a head-to-head study where steroid therapy (topical or insert) will begin in a standard fashion on the date of CXL. This will allow for accurate comparison of a 4-week taper of topical steroids, versus a dexamethasone insert designed to release steroid for 30 days.

Eligibility 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

Primary outcomes:
measure: Change in Degree of Postoperative Pain Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)
timeFrame: Assessed at 1 day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)
measure: Degree and Improvement of Ocular Surface Inflammation Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)
timeFrame: assessed at day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)
Secondary outcomes:
measure: Rate of Corneal Re-epithelialization
timeFrame: Assessed at 1 day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)
measure: Subjective 'Ease of Postoperative Care' for Patients Receiving Standard Topical Steroid Eye Drop Taper vs. Dexamethasone Insert
timeFrame: postoperative week 4 (POW4)
measure: Notation of Need for Use of "Rescue" Pain Medication
timeFrame: Assessement of use of additional/adjunctive pain/antiinflammatory medications will be done for each patient at postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)
Other outcomes:
Locations:
city: Babylon
country: United States
facility: SightMD
state: New York
Study officials:
affiliation: Sight Medical Doctors PLLC
name: Alanna Nattis, DO
role: PRINCIPAL_INVESTIGATOR
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