Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery

Study Overview
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Brief Summary
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This research will evaluate the efficacy of Omidria and Dexycu, Omidria and Dextenza, and Omidria and prednisolone acetate 1% in the resolution of post-operative inflammation and pain following cataract surgery.

Detailed Description
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Prospective, randomized trial where patients will be randomly assigned to 1 of 3 groups, each with a sample size of 25 (total n=75). Group 1 will receive DEXYCU + Omidria (Omidria = ketorolac + phenylephrine), group 2 will receive DEXTENZA + Omidria, and group 3 will receive prednisolone acetate + Omidria. Each of the drug combinations used in each of the 3 groups is standard of care, FDA approved, and will be used on label. 1:1:1, n=75 with 25 subjects assigned to each of the 3 groups.

Official Title
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Evaluation of Efficacy in the Resolution of Post-Operative Inflammation and Pain in Patients Receiving Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery

Conditions
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Cataract Surgery

Intervention / Treatment
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* Drug: Omidria
* Drug: Dextenza (dexamethasone ophthalmic insert) 0.4mg
* Drug: Dexycu, 9% Intraocular Suspension
* Drug: Prednisolone Acetate 1%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of age or older, undergoing routine, uncomplicated cataract surgery. Exclusion Criteria: Any history of corneal dystrophy, corneal surgery within 6 months of cataract surgery, previous intraocular surgery, any concomitant eye drop use besides artificial tears, previous ocular trauma, or a history of treated glaucoma. No additional procedures can be done at the time of cataract surgery (e.g., stent placement, endo-laser, etc.), but femto-second laser-assisted surgery is permitted.
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: Patients will be randomly assigned to 1 of 3 groups (1:1:1), each with a sample size of 25 (total n=75). Group 1 will receive DEXYCU + Omidria (Omidria = ketorolac + phenylephrine), group 2 will receive DEXTENZA + Omidria, and group 3 will receive prednisolone acetate + Omidria.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omidria + Dextenza (dexamethasone ophthalmic insert) 0.4mg<br>Omidria (= ketorolac + phenylephrine) and intracanalicular dexamethasone insert (punctal plug) | Drug: Omidria<br>* phenylephrine 1% and ketorolac 0.3% intraocular solution<br>Drug: Dextenza (dexamethasone ophthalmic insert) 0.4mg<br>* intracanalicular dexamethasone insert<br>|
| Experimental: Omidria + Dexycu<br>Omidria (= ketorolac + phenylephrine) and intraocular dexamethasone suspension | Drug: Omidria<br>* phenylephrine 1% and ketorolac 0.3% intraocular solution<br>Drug: Dexycu, 9% Intraocular Suspension<br>* dexamethasone intraocular suspension<br>|
| Active Comparator: Omidria + Prednisolone Acetate 1%<br>Omidria (= ketorolac + phenylephrine) and topical prednisolone acetate ophthalmic drops | Drug: Omidria<br>* phenylephrine 1% and ketorolac 0.3% intraocular solution<br>Drug: Prednisolone Acetate 1%<br>* standard postoperative ophthalmic drop regimen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of anterior chamber inflammation | The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute. | Assessed at day 8 post-operatively | 
| Resolution of anterior chamber inflammation | The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute. | Assessed at day 15 post-operatively | 
| Resolution of anterior chamber inflammation | The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute. | Assessed at day 30 post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of postoperative pain | The secondary efficacy endpoint is the elimination of post-operative pain per a subjective, standardized scale. Post-operative pain as measured on a scale from 0-10 (ocular pain assessment). | Assessed at day 1 post-operatively | 
| Resolution of postoperative pain | The secondary efficacy endpoint is the elimination of post-operative pain per a subjective, standardized scale. Post-operative pain as measured on a scale from 0-10 (ocular pain assessment). | Assessed at day 8 post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dextenza, intracanalicular dexamethasone, dexamethasone ophthalmic insert, Dexycu, Omidria