A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1%

Cataract Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04273282
• Other study ID #: 1909 D3 EyePoint
• Status: Completed
• Phase: Phase 4
• Start date: December 16, 2019
• Est. completion date: November 24, 2020

Study information

• Verified date: April 2020
• Source: Research Insight LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 24, 2020
• Est. primary completion date: November 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Dexycu intracameral dexamethasone
To evaluate the safety and ocular efficacy of Dexycu.
• Prednisolone Acetate
To evaluate the safety and ocular efficacy, and patient acceptance of post cataract surgery drug treatment regimen that minimizes topical medications.

Locations

Country	Name	City	State
United States	Ophthalmic Consultants of Long Island	Garden City	New York
United States	Harvard Eye Associates	Laguna Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Research Insight LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Subject evaluation of postop ocular pain in 30 randomized subjects	Study subject evaluation of post-op ocular pain.	Day 28
Secondary	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
Secondary	Medication cost in 30 randomized subjects	Cost of medications to the patient (patient-reported)	Day 28