A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1%

Sponsor

Research Insight LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT04273282

Collaborator

(none)

Enrollment

Locations

Arms

11.3

Actual Duration (Months)

15.5

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: Dexycu intracameral dexamethasone Drug: Prednisolone Acetate	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Single (Participant)

Masking Description:

Only the participants will be masked.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 16, 2019

Actual Primary Completion Date :

Nov 24, 2020

Actual Study Completion Date :

Nov 24, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Patient preference for medication protocol in 30 randomized subjects [Day 28]
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 [Day 28]
Study subject evaluation of post-op ocular pain.
Summed Ocular Inflammation Score in 30 randomized subjects [Day 28]
Summed Ocular Inflammation Score (sum of the mean anterior chamber cells and anterior flare score)
Medication cost in 30 randomized subjects [Day 28]
Cost of medications to the patient (patient-reported)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.