A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1%

The D3 Study: Drug Delivery vs Drops - A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1% in Controlling Post-operative Pain and Inflammation in Patients Undergoing Sequential Cataract Surgery

This is a post-approval, open-label, randomized, self-controlled prospective clinical study to evaluate the safety and ocular efficacy of Dexycu in controlling postoperative ocular pain and inflammation associated with cataract surgery.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Drug: Dexycu intracameral dexamethasone; Drug: Prednisolone Acetate

Detailed Description

On initial consultation, each study subject will be randomized by a table in the possession of investigators to receive one of two treatment groups, either experimental or control in the first eye. The second eye will undergo cataract surgery approximately 2 weeks later and will be treated with the other treatment group:

Dexycu Group: A total of 30 study subjects will have Dexycu intracameral dexamethasone placed in their scheduled surgical eye at the time of surgery and will receive 50 micrograms of intracameral moxifloxacin at the conclusion of the procedure. They will take Prolensa each day after surgery for 4 weeks.

Control Group: A total of 30 study subjects will receive topical moxifloxacin 0.5% four times per day 1 day prior to surgery and for ten days postoperatively, Prolensa every day 1 day prior to surgery and for 4 weeks postoperatively, and prednisolone acetate 1.0% four times per day starting at the conclusion of cataract surgery for 2 weeks and twice per day for 2 weeks in their scheduled surgical eye.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Laguna Hills, California, United States, 92653
      • Harvard Eye Associates
  • New York
    • Garden City, New York, United States, 11530
      • Ophthalmic Consultants of Long Island

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A male or female in good general health, greater than 18 years of age at time of screening.
• Must be able to comprehend and willing to give informed consent.
• Woman of child-bearing potential must not be pregnant or lactating.
• Subject has availability, willingness, and sufficient cognitive awareness to comply with exam procedures and able to return for all scheduled study visits.
• Subject with cataract for which routine phacoemulsification extraction and implantation of an intraocular lens has been planned.
• Subject with an OCT of the macula in both eyes that demonstrates no significant pathology.

Exclusion Criteria:

• Subject with any signs of intraocular inflammation in either eye at screening.
• Subject with a known sensitivity to any of the study medications.
• Subject with only one eye with potentially good vision.
• Subject that has undergone prior intraocular surgery in the scheduled surgical eye within the last 6 months or laser surgery within three months prior to screening.
• Subject with pupil abnormalities.
• Subject with corneal abnormalities.
• Subject with a history of chronic/recurrent inflammatory eye disease in either eye.
• Subject with uncontrolled glaucoma.
• Subject expected to undergo surgical intervention and/or ocular laser treatment prior to or during the study period.
• Subject who requires use of systemic or ocular medications that may affect vision, ocular inflammation, or pain.
• Subject with an acute or chronic disease or illness that would increase risk or confound study results, e.g. autoimmune disease, etc.
• Subject with an uncontrolled systemic disease.
• Subject with poorly-controlled diabetes.
• Subject currently participating or has participated in another clinical trial within 30 days prior to enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexycu Group; A total of 30 study subjects (30 eyes) will have Dexycu intracameral dexamethasone placed in their scheduled surgical eye at the time of surgery and will receive 50 micrograms of intracameral moxifloxacin at the conclusion of the procedure. They will take Prolensa qd after surgery for 4 weeks.	Drug: Dexycu intracameral dexamethasone; To evaluate the safety and ocular efficacy of Dexycu.; Other Names: Moxifloxacin 0.5%; Prolensa
Active Comparator: Control Group; A total of 30 study subjects (30 eyes) will receive topical moxifloxacin 0.5% qid 1 day prior to surgery and for ten days postoperatively, Prolensa qd 1 day prior to surgery and for 4 weeks postoperatively, and prednisolone acetate 1.0% qid starting at the conclusion of cataract surgery for 2 weeks and bid for 2 weeks in their scheduled surgical eye.	Drug: Prednisolone Acetate; To evaluate the safety and ocular efficacy, and patient acceptance of post cataract surgery drug treatment regimen that minimizes topical medications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient preference for medication protocol in 30 randomized subjects	Patient preference for medication protocol between the two eyes, as reported based on the question, "Thinking about your overall experience taking medications in each eye after surgery, which eye did you prefer? Questionnaire	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject evaluation of postop ocular pain in 30 randomized subjects	Study subject evaluation of post-op ocular pain.	Day 28
Summed Ocular Inflammation Score in 30 randomized subjects	Summed Ocular Inflammation Score (sum of the mean anterior chamber cells and anterior flare score)	Day 28
Medication cost in 30 randomized subjects	Cost of medications to the patient (patient-reported)	Day 28

Collaborators and Investigators

• Sponsor: Research Insight LLC

Publications and helpful links

General Publications

• Hovanesian JA, Donnenfeld ED. Intracameral dexamethasone 9% vs prednisolone acetate 1% in controlling postoperative pain and inflammation in patients undergoing cataract surgery. J Cataract Refract Surg. 2022 Aug 1;48(8):906-911. doi: 10.1097/j.jcrs.0000000000000887. Epub 2022 Jan 18.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2019
• Primary Completion (Actual): November 24, 2020
• Study Completion (Actual): November 24, 2020

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Dexamethasone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Moxifloxacin
• Other Study ID Numbers: 1909 D3 EyePoint

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

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