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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04168112
Recruitment Status : Active, not recruiting
First Posted : November 19, 2019
Last Update Posted : January 19, 2022
Sponsor:
Collaborator:
Ocular Therapeutix, Inc.
Information provided by (Responsible Party):
Alanna Nattis, DO, Sight Medical Doctors PLLC

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.

Condition or disease Intervention/treatment Phase
Keratoconus, Unstable Collagen Crosslinking Postoperative Pain Drug: Dextenza Drug: Prednisolone Acetate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).

Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: Group A
Intracanalicular dexamethasone insert is placed on day of crosslinking (CXL); patients will still receive postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days).
Drug: Dextenza
Placement of intracanalicular dexamethasone insert for post-crosslinking inflammation and pain
Other Name: Intracanalicular dexamethasone insert

Active Comparator: Group B
Patients are placed on standard postoperative regimen of postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days) and Prednisolone acetate 1% ophthalmic solution tapered over 1 month in the following schedule: QID x1 week, TID x 1 week, BID x 1 week, and Qday x 1 week.
Drug: Prednisolone Acetate
post-crosslinking eye drop prednisolone acetate given in a tapering schedule over 1 month




Primary Outcome Measures :
  1. Change in degree of postoperative pain between groups from date of surgery to 1 month post-CXL [ Time Frame: Assessed at 1 day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total) ]
    Utilizing the standardized Wong-Baker visual analog pain scale, graded from 0 to 10 (no pain to increasingly worse pain (worst at 10/10))

  2. Degree and improvement of ocular surface inflammation between groups from date of surgery to 1 month post-CXL [ Time Frame: assessed at baseline, 1 day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (8 visits total) ]
    Assessment of corneal edema/cells (if any), degree of conjunctival injection (if any) Grading will be standardized according to the Brien Holden Vision Institute grading system


Secondary Outcome Measures :
  1. Rate of corneal re-epithelialization [ Time Frame: Assessed at 1 day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total) ]
    Evaluation of rate of corneal re-epithelialization post-crosslinking

  2. Subjective 'ease of postoperative care' for patients receiving standard topical steroid eye drop taper vs. dexamethasone insert [ Time Frame: postoperative week 4 (POW4) ]
    Questionnaire at final visit regarding ease of postoperative eye drop use

  3. Notation of need for use of "rescue" pain medication [ Time Frame: 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) ]
    Use of oral non-steroidal antiinflammatory (NSAID), acetaminophen, prescribed pain medication) between groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04168112


Locations
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United States, New York
SightMD
Babylon, New York, United States, 11702
Sponsors and Collaborators
Sight Medical Doctors PLLC
Ocular Therapeutix, Inc.
Investigators
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Principal Investigator: Alanna Nattis, DO Sight Medical Doctors PLLC
Publications:

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Responsible Party: Alanna Nattis, DO, Ophthalmologist, Director of Clinical Research, Sight Medical Doctors PLLC
ClinicalTrials.gov Identifier: NCT04168112    
Other Study ID Numbers: LINK1
First Posted: November 19, 2019    Key Record Dates
Last Update Posted: January 19, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share individual participant data (IPD) with other researchers. However, any adverse events will be reported to the governing institutional review board (IRB) and Ocular Therapeutix and FDA if applicable.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alanna Nattis, DO, Sight Medical Doctors PLLC:
Collagen Crosslinking
Keratoconus
Dexamethasone
Intracanalicular Insert
Additional relevant MeSH terms:
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Keratoconus
Inflammation
Pathologic Processes
Corneal Diseases
Eye Diseases
Dexamethasone
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Neuroprotective Agents
Protective Agents