Dextenza Insert for Post-Cataract Surgery Inflammation
NR
OS
Overseen ByOrly Shiler
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Nicole Fram M.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
What You Need to Know Before You Apply
What is the purpose of this trial?
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery
Who Is on the Research Team?
NR
Nicole Fram, M.D.
Principal Investigator
Advanced Vision Care
Are You a Good Fit for This Trial?
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.
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Timeline for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimenExperimental Treatment2 Interventions
Group II: Arm 1 - Cataract surgery gtt regimen per SOCActive Control2 Interventions
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nicole Fram M.D.
Lead Sponsor
Trials
3
Recruited
110+
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