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

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract Surgery
• Intervention / Treatment: Drug: Omidria; Drug: Dextenza (dexamethasone ophthalmic insert) 0.4mg; Drug: Dexycu, 9% Intraocular Suspension; Drug: Prednisolone Acetate 1%

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64133
      • Silverstein Eye Centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optical Coherence Tomography (OCT)	OCT is a non-contact, non-invasive test that takes less than a minute to perform. All that is required of the patient is that they sit still and look at a fixation light while the machine takes a picture. No eye drops or any other intervention are required. OCT scanning will provide an image of the deep layers of the retina and will be used to determine macular thickness measurement (macular thickness has been correlated to changes in contrast sensitivity) before and 30 days following surgery. .	Assessed pre-operatively and 1 month post-operatively
Contrast sensitivity testing	This test is non-contact, non-invasive and used to distinguish between finer and finer increments of light versus dark. The patient simply looks at a chart similar to the Snellen Eye Chart and distinguishes lighter shades from darker shades. The test is performed in less than one minute.	Assessed pre-operatively, and at 15 days and 30 days post-operatively
Best corrected visual acuity	ETDRS chart at 4m	Assessed pre-operatively, and at 15 days and 30 days post-operatively
Optical Coherence Tomography (OCT)	OCT is a non-contact, non-invasive test that takes less than a minute to perform. All that is required of the patient is that they sit still and look at a fixation light while the machine takes a picture. No eye drops or any other intervention are required. OCT scanning will provide an image of the deep layers of the retina and will be used to evaluate for the presence of cystoid macular edema before and 30 days following surgery.	Assessed pre-operatively and 1 month post-operatively

Collaborators and Investigators

• Sponsor: Silverstein Eye Centers
• Collaborators: Ocular Therapeutix, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Actual): December 23, 2020
• Study Completion (Actual): December 23, 2020

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: March 18, 2020
• First Posted (Actual): March 20, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Dextenza; intracanalicular dexamethasone; dexamethasone ophthalmic insert; Dexycu; Omidria
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Dexamethasone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes