Dextenza Insert for Post-Cataract Surgery Inflammation

Overseen By Orly Shiler

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Nicole Fram M.D.

Must not be taking: Immunosuppressants, Oral steroids

Disqualifiers: Under 18, Pregnant, Ocular inflammation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 91

Duration: 4 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Nicole Fram, M.D.

Principal Investigator

Advanced Vision Care

Eligibility Criteria

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.

Inclusion Criteria

Are willing and able to comply with clinic visits and study related procedures

Are willing and able to sign the informed consent form

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

Exclusion Criteria

I am currently receiving treatment with a corticosteroid implant.

Pregnant or planning to become pregnant during the trial period

I do not have an active infectious disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the DEXTENZA 0.4 mg insert with a reduced topical drop regimen or the standard of care topical drop regimen following cataract surgery

4 weeks

Visits on Day 1, 7, 30

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of visual acuity, corneal staining, and inflammation

90 days

Visits on Day 90

Treatment Details

Interventions

• Bromfenac
• Dextenza
• Moxifloxacin
• Prednisolone Acetate
• Prednisolone Phosphate
• Prolensa

Trial Overview 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.

Participant Groups

Group I: Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimen Experimental Treatment 2 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 SOC Active Control 2 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.

Who Is Running the Clinical Trial?

Nicole Fram M.D.

Lead Sponsor

Trials

3

Recruited

110+