The RESTORE Study, A Randomized, Controlled, Masked (Reading Center) Prospective Study

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 PRK surgery.

Detailed Description
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Prospective Open-label Interventional Study Randomized, self-controlled design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, BID 1 week following bilateral PRK surgery. All eyes will receive topical moxifloxacin QID for one week. Moxifloxacin in used post-op regardless of the research. Post-operative evaluations to be performed on Day 3 and Day 4, Month 1, and Month 3. Phone call survey to be performed on Week 2.

Official Title
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A Randomized, Controlled, Masked (Reading Center) Prospective Study of the Effectiveness and Safety of the Ocular Therapeutix Dextenza (Dexamethasone Ophthalmic Insert) 0.4 mg for the Treatment of Post-operative Inflammation and Pain in Patients Who Have Undergone PhotoREfractive Keratectomy (PRK)

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 PRK 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. 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 intracameral antibiotic. Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day Patients with a corticosteroid implant (i.e. Ozurdex). Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes. Patients who do not have 20/20 snellen visual acuity potential pre-operatively. MRSE greater than 6 diopters. Greater than 2 diopters anisometropia.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A Dextenza<br>Will receive Dextenza post-operative | 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>|
| Group B Topical Prednisolone<br>Will receive standard of care prednisolone acetate 1% QID for 1 week, BID for 1 week | 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 | Primary outcome of patient reference of dexamethasone insert versus topical steroid as measured by adapted Comparison of Ophthalmic Medications for Tolerability (COMToL) questionnaire. | Through Month 1 (Day 28 +/- 3 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Eyes Epithelialized at Day 3 | The percentage of eyes with fully healed epithelium at post-op day 3 | Post-Operative Day 3 | 
| Percentage of Eyes Fully Epithelialized at Day 4 Postoperative | The percentage of eyes with fully healed epithelium at day 4 post-operative | Postoperative Day 4 | 
| Mean Pain Score Per Eye (Group A: Dextenza vs. Group B: Topical Steroid) | Pain score as measured by the Numerical Rating Scale (NRS) at day 3 post-operative. The rating scale is from 0-10 with 0 being no pain and 10 being severe pain. | Day 3 | 
| SPEED Questionnaire Results at Baseline and Postoperative Day 28 | Patient evaluation of eye dryness measured by a modified SPEED questionnaire with a results recorded 0-28 with 28 being the most severe. | Pre-op Visit and Month 1 (Day 28) | 
| Uncorrected Distance Visual Acuity | measured using the ETDRS acuity chart at 4 meters recorded in logMAR. | Month 1 and Month 3. | 
| Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative | Best-corrected distance visual acuity measured using ETDRS acuity chart at 4 meters, recorded in logMAR notation | Month 1 and Month 3 |