DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK Surgery

Study Overview
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Brief Summary
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To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral LASIK surgery.

Detailed Description
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This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate the outcomes of patients undergoing bilateral LASIK surgery with the treatment of a dexamethasone intracanalicular insert compared to standard of care topical prednisolone. All eyes will receive treatment. Additionally, all eyes will receive topical moxifloxacin QID for 1 week. Twenty patient eyes undergoing bilateral LASIK surgery will be randomized to receive either Dextenza (Group A) OR standard of care prednisolone acetate 1% QID for 1 week, BID for 1 week (Group B). The contralateral eye will receive treatment with either DEXTENZA or topical prednisolone as a comparator based on randomization of first eye to Group A or Group B. Post-operative evaluations will be performed on Day 1, Day 7, and Month 1 following surgery.

Official Title
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DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK

Conditions
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Refractive Surgery

Intervention / Treatment
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* Drug: Dextenza 0.4Mg Ophthalmic Insert
* Drug: Topical Prednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any adult patient who is planned to undergo bilateral LASIK surgery. Refractive error between the 2 eyes of 2 Diopters or less Willing and able to comply with clinic visits and study related procedures Willing and able to sign the informed consent form Exclusion Criteria: Patients under the age of 18. Patients who choose to have monovision after LASIK Patients with corneal pathology that may interfere with LASIK outcomes Patients who are pregnant (must be ruled out in women of child-bearing age with pregnancy test). Active infectious ocular or systemic disease. Patients with active infectious ocular or extraocular disease. Patients actively treated with local or systemic immunosuppression including systemic corticosteroids. Patients with known hypersensitivity to Dexamethasone. Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator. Patients with a history of ocular inflammation or macular edema. Patients with allergy or inability to receive topical antibiotic. Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day Patients with a corticosteroid implant (i.e. Ozurdex). Active or history of chronic or recurrent inflammatory eye disease in either eye Ocular pain in either eye Proliferative diabetic retinopathy in either eye Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye Laser or incisional ocular surgery during the study period and 6 months prior in either eye History of cauterization of the punctum

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Dextenza | Drug: Dextenza 0.4Mg Ophthalmic Insert<br>* The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.<br>|
| Active Comparator: Group B<br>Topical Prednisolone | Drug: Topical Prednisolone<br>* Standard of care topical drop treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Preference | As measured by COMTOL adapted survey. | Through Month 1 (Day 28 +/- 3 days) | 
| Patient Comfort | As measured by SPEED Questionnaire. | Through Month 1 (Day 28 +/- 3 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Health | As measured by corneal staining. | Through Month 1 (Day 28 +/- 3 days) | 
| Visual Outcomes | As measured by uncorrected Visual Acuity. | Through Month 1 (Day 28 +/- 3 days) | 
| Ocular Pain | As measured by Ocular Pain Assessment. | Through Month 1 (Day 28 +/- 3 days) |