The PRIME Study: A Randomized, Controlled, Prospective Study

Study Overview
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Brief Summary
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To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin and risk of cystoid macular edema post-operatively.

Detailed Description
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A Randomized, Controlled, Prospective Study design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, TID 1 week, BID 1 week, and QD 1week, following bilateral RLE surgery. All eyes will receive topical moxifloxacin QID for one week and topical Ilevro QD for 4 weeks. Moxifloxacin and Ilevero are used in post-op regardless of the research. Post-operative evaluations to be performed on Day 1, Day 7, and 1 Month.

Official Title
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A Randomized, Controlled, 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 in Patients Who Plan to Undergo Refractive Lens Exchange (RLE)

Conditions
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Patient Preference, Patient Outcomes, Post-Operative Inflammation, Grade of Post-Operative Cystoid Macular Edema, Rate of Post-Operative Cystoid Macular Edema

Intervention / Treatment
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* Drug: Dextenza
* 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 RLE surgery with BCVA 20/30 or better 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 22 or above the age of 75 Patients who are pregnant (must be ruled out in a women of child-bearing age with pregnancy test). Patients with active infectious ocular or extraocular disease. Patients actively treated with local or systemic immunosuppression including systemic corticosteriods Paitents with know hypersensitivity to Dexamethasone Patients with severe disease that warrants critical attentino, 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) grater than 1,200 mg/day Patient with a corticosteriod implant (i.e. Ozurdex). Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A Dextenza<br>Drug: Dextenza 0.4mg Opthalmic Insert 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 risks for improper corticosteriod tapering and unwanted peaks and troughs in drug concentration. | Drug: Dextenza<br>* Dextenza 0.4mg<br>|
| Active Comparator: Group B Topical Prednisolone<br>Drug: Topical Prednisolone Standard of care topical drop treatment | 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 adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) survey (This is measured on a scale of 1-10 with 10 being a worse outcome) | Through Month 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of eyes that have CME (Cystoid macular edema) post-operatively | Measured by OCT (Optical Coherence Tomography ) | Through Month 1 | 
| Mean pain score per eye (Group A vs Group B) | Measured by Visual Analog Scale (0-10, 10 being the worst outcome) | Through Month 1 | 
| Incidence of post-operative corneal haze | measured by OCT (Optical Coherence Tomography) | Through Month 1 | 
| Grade of post-operative corneal haze | measured by OCT (Optical Coherence Tomography) | Through Month 1 | 
| Anterior chamber cell count | measured by SUN Working Group Grading Scheme | Through Month 1 | 
| Uncorrected Visual Acuity | measured by ETDRS chart a 4m | Through Month 1 | 
| Best Corrected Visual Acuity | measured by ETDRS chart a 4m | Through Month 1 |