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NSAID
Dextenza Insert for Post-Cataract Surgery Inflammation
Phase 4
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed on days 1,7,30,90
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
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.
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.
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.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean change in anterior chamber inflammation (Cell and Flare) scores
Mean change in pain score
Secondary study objectives
Absence of CME (Cystoid Macular Edema)
Mean change in corneal staining
Visual outcome (Best Corrected Visual Acuity)
Other study objectives
Safety endpoint: Change in IOP (IntraOcular Pressure) initiating rescue medications
Safety endpoint: Signs of Rebound Iritis
Safety endpoint: corneal or retinal edema
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving treatment with a corticosteroid implant.I do not have an active infectious disease.I have a blocked tear duct in my eye.I have had eye inflammation or swelling in the past.I have had or currently have an eye infection caused by herpes, bacteria, virus, or fungus.I am under 18 years old.I have an active eye infection.I have had LASIK or PRK eye surgery.I am currently taking immunosuppressants or oral steroids.I am currently using eye drops that contain steroids.I am currently receiving treatment with immune system affecting drugs for my eye.I am diagnosed with a significant cataract and plan to have surgery.I have had a procedure to close the tear duct in one or both eyes.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 - Cataract surgery gtt regimen per SOC
- Group 2: Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimen
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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