Assessing Dextenza Insert After SMILE Procedure

Study Overview
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Brief Summary
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This three-month prospective, open-label, single-center, randomized investigator initiated clinical study seeks to investigate the efficacy of DEXTENZA when placed in the lower canaliculus (study eye) compared to topical corticosteroids (control eye) following bilateral SMILE surgery. In addition, the study will evaluate physician assessment of ease of DEXTENZA insertion

Detailed Description
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4.1 Study Population The study aims to enroll 20 patients undergoing bilateral SMILE. 4.1.1 Inclusion Criteria A patient's study eye must meet the following criteria to be eligible for inclusion in the study: Age 18 years and older Scheduled for bilateral SMILE surgery Willing and able to comply with clinic visits and study related procedures Willing and able to sign the informed consent form 4.1.2 Exclusion Criteria A patient who meets any of the following criteria will be excluded from the study: Patients under the age of 18. Pregnancy (must be ruled out in women of child-bearing age with pregnancy test) Active infectious systemic disease Active infectious ocular or extraocular disease Obstructed nasolacrimal duct in the study eye(s) Hypersensitivity to dexamethasone Patients being treated with immunomodulating agents in the study eye(s) Patients being treated with immunosuppressants and/or oral steroids Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Official Title
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Assessing the Efficacy of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Comparison to Topical Prednisolone Acetate Following Bilateral Small Incision Lenticule Extraction (SMILE)

Conditions
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Post Procedural Infection

Intervention / Treatment
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* Drug: Dexamethasone ophthalmic insert 0.4 mg
* Drug: Topical Prednisolone Acetate Ophthalmic Drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older Scheduled for bilateral SMILE surgery 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. Pregnancy (must be ruled out in women of child-bearing age with pregnancy test) Active infectious systemic disease Active infectious ocular or extraocular disease Obstructed nasolacrimal duct in the study eye(s) Hypersensitivity to dexamethasone Patients being treated with immunomodulating agents in the study eye(s) Patients being treated with immunosuppressants and/or oral steroids Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: First eye randomized for either topical prednisolone acetate (control eye) or lower eyelid canaliculus Dextenza insertion (study eye) and the contralateral eye receiving opposite treatment in the OR following SMILE
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone ophthalmic insert 0.4 mg<br>Dexamethasone ophthalmic insert 0.4 mg | Drug: Dexamethasone ophthalmic insert 0.4 mg<br>* intracanalicular dexamethasone insert<br>* Other names: Dextenza;|
| Active Comparator: Topical prednisolone acetate ophthalmic drops<br>topical prednisolone acetate ophthalmic drops | Drug: Topical Prednisolone Acetate Ophthalmic Drops<br>* Topical Prednisolone acetate ophthalmic drops per standard of care: Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue<br>* Other names: Prednisolone Acetate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Pain | post-op pain as measured as scores on an Ocular Pain Assessment Scale from 0-10 (0 being no pain and 10 being the worst pain you could imagine) | Change is being assessed at Baseline, Day 1, Day 7, Day 30 and Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Lines Lost From Best Corrected Visual Acuity | After manifest refraction all units assessed for best corrected distance visual acuity using ETDRS. Number of lines seen was then converted to LogMar score (on a scale of -0.30 to 1.00 where smaller numbers indicate better vision and larger numbers indicate worse vision) to measure changes in Best Corrected Distance Visual Acuity between Baseline and Day 90 | Baseline through Day 90 | 
| Loss of Lines in Uncorrected Visual Acuity | All units assessed for uncorrected visual acuity using ETDRS. Number of lines seen was then converted to LogMar to measure changes in uncorrected visual acuity between Baseline and Day 90. | Baseline to Day 7, Day 30 and Day 90 | 
| Post op Pain Management Per Eye | Count of participants requiring pain management from Day 0 to Day 90. | Day 0 to Day 90 | 
| Patient Preference Between Groups | As reported by patients choosing one of five options; Strongly preferred insert, preferred insert, no preference, preferred standard drop regimen, strongly preferred standard drop regimen. | Day 7, Day 30 and Day 90 |