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NSAID

Dextenza Insert for Post-Cataract Surgery Inflammation

Phase 4

Recruiting

Led By Nicole R Fram, M.D.

Research Sponsored by Nicole Fram M.D.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with clinically significant cataract and are planning to undergo non-complicated Clear Cornea Incision Cataract Extraction with Posterior Capsule IntraOcular Lens in one or both eyes

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed on days 1,7,30,90

Awards & highlights

Study Summary

This trial studied the effectiveness and safety of a drug inserted after cataract surgery to reduce inflammation.

Who is the study for?

This trial is for adults with significant cataracts scheduled for Clear Cornea Incision Cataract Extraction. Participants must be able to consent and follow the study plan. Excluded are those under 18, pregnant, known steroid responders, have poor visual potential or active infections, use immunosuppressants or oral steroids, have a history of certain eye conditions or surgeries.Check my eligibility

What is being tested?

The trial tests DEXTENZA (a dexamethasone insert) against standard treatments like Prednisolone Acetate and Prolensa drops after cataract surgery. It aims to see if DEXTENZA can better reduce inflammation and pain while improving visual outcomes post-surgery.See study design

What are the potential side effects?

Possible side effects include eye irritation or discomfort, increased intraocular pressure leading to glaucoma risk, delayed healing of the eye surface after surgery, infection risks due to immune response suppression by steroids.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am diagnosed with a significant cataract and plan to have surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed on days 1,7,30,90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed on days 1,7,30,90

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed on days 1,7,30,90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean change in anterior chamber inflammation (Cell and Flare) scores

Mean change in pain score

Secondary outcome measures

Absence of CME (Cystoid Macular Edema)

Mean change in corneal staining

Visual outcome (Best Corrected Visual Acuity)

Other outcome measures

Safety endpoint: Change in IOP (IntraOcular Pressure) initiating rescue medications

Safety endpoint: Signs of Rebound Iritis

Safety endpoint: corneal or retinal edema

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimenExperimental Treatment2 Interventions

Following cataract surgery with DEXTENZA 0.4mg insert, patients will receive: Prolensa 0.07% QD X 4 Weeks and stop

Group II: Arm 1 - Cataract surgery gtt regimen per SOCActive Control2 Interventions

Following cataract surgery (without Dextenza 0.4mg insert) patients will receive: Prednisolone Acetate 1% QID X 2 Weeks, then BID x 2 weeks and stop / Prolensa 0.07% QD X 4 Weeks and stop.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dextenza 0.4Mg Ophthalmic Insert

2020

Completed Phase 4

~210

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nicole Fram M.D.Lead Sponsor

2 Previous Clinical Trials

61 Total Patients Enrolled

Nicole R Fram, M.D.Principal InvestigatorAdvanced Vision Care

1 Previous Clinical Trials

25 Total Patients Enrolled

Media Library

Bromfenac (NSAID) Clinical Trial Eligibility Overview. Trial Name: NCT05626478 — Phase 4

Cystoid Macular Edema Research Study Groups: Arm 1 - Cataract surgery gtt regimen per SOC, Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimen

Cystoid Macular Edema Clinical Trial 2023: Bromfenac Highlights & Side Effects. Trial Name: NCT05626478 — Phase 4

Bromfenac (NSAID) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05626478 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Arm 2 - Cataract Surgery with Dextenza and reduced dosage plan been given the go-ahead by the FDA?

"With proven efficacy and safety, Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimen received a score of 3."

Answered by AI

Is the current enrollment period open to participants?

"As observed on clinicaltrials.gov, enrollment for this trial is currently suspended; it was initially launched December 1st 2022 and last amended November 15th 2022. Nonetheless, there are 588 other studies actively recruiting patients at present."

Answered by AI

Recent research and studies

Clinical OphthalmologyJournal

<p>a Randomized Fellow-eye Clinical Trial to Evaluate Patient Preference for Dexamethasone Intracanalicular Insert or Topical Prednisolone Acetate for Control of Postoperative Symptoms Following Bilateral Femtosecond Laser in Site Keratomileusis (lasik)</p>

Greenwood, Michael D, Richard A Gorham, and Keeley R Boever. 2020. “a Randomized Fellow-eye Clinical Trial to Evaluate Patient Preference for Dexamethasone Intracanalicular Insert or Topical Prednisolone Acetate for Control of Postoperative Symptoms Following Bilateral Femtosecond Laser in Site Keratomileusis (lasik)”. Clinical Ophthalmology. Informa UK Limited. doi:10.2147/opth.s265311.

Journal of Cataract and Refractive SurgeryJournal

Multicenter Randomized Phase 3 Study of a Sustained-release Intracanalicular Dexamethasone Insert for Treatment of Ocular Inflammation and Pain After Cataract Surgery

Tyson, Syd L., Shamik Bafna, Joseph P. Gira, Damien F. Goldberg, Jason J. Jones, Michael P. Jones, Janet K. Kim, et al.. 2019. “Multicenter Randomized Phase 3 Study of a Sustained-release Intracanalicular Dexamethasone Insert for Treatment of Ocular Inflammation and Pain After Cataract Surgery”. Journal of Cataract and Refractive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.jcrs.2018.09.023.

clinicaltrials.govStudy

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

Nicole Fram M.D. 2023. "Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05626478.

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