A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1%

NCT04273282 | Completed Phase 4 FDA Drug

• 1 other identifier: 1909 D3 EyePoint
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Subject evaluation of postop ocular pain in 30 randomized subjects

  Day 28

• Summed Ocular Inflammation Score in 30 randomized subjects

  Day 28

• Medication cost in 30 randomized subjects

  Day 28

Study Arms (2)

Dexycu Group

ACTIVE COMPARATOR

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Dexycu intracameral dexamethasone DRUG

To evaluate the safety and ocular efficacy of Dexycu.

Also known as: Moxifloxacin 0.5%, Prolensa

Dexycu Group

Prednisolone Acetate DRUG

To evaluate the safety and ocular efficacy, and patient acceptance of post cataract surgery drug treatment regimen that minimizes topical medications.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Insight LLC: lead

Study Sites (2)

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

Ophthalmic Consultants of Long Island

Garden City, New York, 11530, United States

Location

Related Publications (1)

• 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.

  PMID: 35067660 DERIVED

MeSH Terms

Conditions

Cataract

Interventions

bromfenac; prednisolone acetate

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• John Hovanesian, MD

  Research Insight LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only the participants will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each study subject will be randomized by a table in the possession of investigators to receive one of 2 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% 4 times per day 1 day prior to surgery and for 10 days postoperatively, Prolensa every day 1 day prior to surgery and for 4 weeks postoperatively, and prednisolone acetate 1% 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 Record Dates

• First Submitted: December 18, 2019
• First Posted: February 18, 2020
• Study Start: December 16, 2019
• Primary Completion: November 24, 2020
• Study Completion: November 24, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)