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A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1%

Primary Purpose

Cataract

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Dexycu intracameral dexamethasone

Prednisolone Acetate

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Harvard Eye Associates
Ophthalmic Consultants of Long Island

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Dexycu Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Subject evaluation of postop ocular pain in 30 randomized subjects

Study subject evaluation of post-op ocular pain.

Summed Ocular Inflammation Score in 30 randomized subjects

Summed Ocular Inflammation Score (sum of the mean anterior chamber cells and anterior flare score)

Medication cost in 30 randomized subjects

Cost of medications to the patient (patient-reported)

Full Information

NCT ID

NCT04273282

First Posted

December 18, 2019

Last Updated

December 9, 2020

Sponsor

Research Insight LLC

1. Study Identification

Unique Protocol Identification Number

NCT04273282

Brief Title

A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1%

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

December 16, 2019 (Actual)

Primary Completion Date

November 24, 2020 (Actual)

Study Completion Date

November 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Research Insight LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

Participant

Masking Description

Only the participants will be masked.

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexycu Group

Arm Type

Active Comparator

Arm Description

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Dexycu intracameral dexamethasone

Other Intervention Name(s)

Moxifloxacin 0.5%, Prolensa

Intervention Description

To evaluate the safety and ocular efficacy of Dexycu.

Intervention Type

Drug

Intervention Name(s)

Prednisolone Acetate

Intervention Description

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

Primary Outcome Measure Information:

Title

Patient preference for medication protocol in 30 randomized subjects

Description

Time Frame

Day 28

Secondary Outcome Measure Information:

Title

Subject evaluation of postop ocular pain in 30 randomized subjects

Description

Study subject evaluation of post-op ocular pain.

Time Frame

Day 28

Title

Summed Ocular Inflammation Score in 30 randomized subjects

Description

Summed Ocular Inflammation Score (sum of the mean anterior chamber cells and anterior flare score)

Time Frame

Day 28

Title

Medication cost in 30 randomized subjects

Description

Cost of medications to the patient (patient-reported)

Time Frame

Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Hovanesian, MD

Organizational Affiliation

Research Insight LLC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Harvard Eye Associates

City

Laguna Hills

State/Province

California

ZIP/Postal Code

92653

Country

United States

Facility Name

Ophthalmic Consultants of Long Island

City

Garden City

State/Province

New York

ZIP/Postal Code

11530

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35067660

Citation

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.

Results Reference

derived

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A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1%

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