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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to manage inflammation after cataract surgery using a tiny insert called Dextenza. Researchers aim to determine if this insert, combined with a simpler eye drop routine, can match the effectiveness of the standard eye drop regimen. Participants will receive either the usual eye drops or the Dextenza insert with fewer drops. The trial seeks individuals diagnosed with cataracts who plan to undergo surgery. As a Phase 4 trial, it involves an FDA-approved treatment and aims to understand how it can benefit more patients.

Do I need to stop my current medications for this trial?

Yes, you will need to stop certain medications. The trial excludes participants who are currently using immunomodulating agents, immunosuppressants, oral steroids, corticosteroid implants, or topical ophthalmic steroid medications.

What is the safety track record for these treatments?

Research has shown that Dextenza, a small insert placed in the eye, is generally safe after cataract surgery. Studies have found that Dextenza effectively reduces eye inflammation and itching. Most people tolerate it well, though some may experience minor side effects like changes in eye pressure or slight inflammation inside the eye.

Similarly, prednisolone acetate drops, another common eye treatment, have demonstrated similar safety levels. The FDA has already approved Dextenza for managing eye inflammation and pain after surgery, indicating it has been reviewed for safety.

Overall, Dextenza appears to be a well-tolerated option for managing inflammation after surgery, with side effects being relatively rare and mild. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard care for post-cataract surgery inflammation, which often requires frequent eye drop regimens over several weeks, the Dextenza insert offers a simpler and potentially more effective alternative. Dextenza is a tiny insert placed in the tear duct that slowly releases medication over time, reducing the need for multiple daily eye drops. Researchers are excited about this treatment because it could lead to better patient compliance and comfort, with fewer chances of missing doses or applying drops incorrectly. This novel delivery method could significantly improve recovery experiences for patients after cataract surgery.

What evidence suggests that this trial's treatments could be effective for post-cataract surgery inflammation?

Research has shown that DEXTENZA, a small insert placed in the eye, effectively reduces pain after cataract surgery. One study found that 97.2% of patients did not feel any pain eight days post-surgery. In this trial, some participants will receive DEXTENZA along with a less frequent regimen of eye drops, while others will follow a standard eye drop regimen without DEXTENZA. DEXTENZA has also proven to work as well as traditional eye drops in reducing swelling and redness after the procedure. Patients who have used DEXTENZA report high satisfaction, finding it more convenient and comfortable than eye drops. These results support its effectiveness and ease of use for managing pain and inflammation after surgery. ^{1 3 6 7 8}

Who Is on the Research Team?

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.

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?

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+

Citations

1. fda.gov fda.gov/media/187107/download

statistical review and evaluation Primary Efficacy Results​​ At 8 days post-surgery, a total of 35/36 (97.2%) study eyes did not have ocular pain (FLACC score of '0') in the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04200651

NCT04200651 | Prospective Study on DEXTENZA® Safety ... The investigators hypothesize that DEXTENZA® will be as safe as prednisolone acetate 1% drops and as effective at controlling postoperative inflammation ...

3. dextenza.com dextenza.com/wp-content/uploads/Tyson-et-al.-J-Cataract-Refract-Surg..pdf

Multicenter randomized phase 3 study of a sustained- ... intracanalicular dexamethasone insert for the treatment of postoperative ocular inflammation and pain in patients having cataract surgery. Setting: Twenty-one ...

4. dextenza.com dextenza.com/why-dextenza/

Why Dextenza Patients reported highly favorable outcomes in comfort, convenience, and satisfaction6. Survey results based on the responses from 201 DEXTENZA patients who ...

5. es.aetna.com es.aetna.com/cpb/medical/data/700_799/0795.html

Dexamethasone Ophthalmic Implant (Ozurdex) and Insert ... More recently, the injection of intra-ocular corticosteroids such as triamcinolone have been found to be effective in reducing ME and improving vision in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11423825/

The Efficacy and Safety of Dexamethasone Intracanalicular ... The pooled results from these trials consistently demonstrated statistically significant improvements in conjunctival itching and redness when ...

7. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=38792&ver=6

LCD - Dexamethasone Intracanalicular Ophthalmic Insert ... The most common Dextenza® ocular adverse events (>1%) were increased (IOP), anterior chamber inflammation including iritis and iridocyclitis, eye inflammation, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9384970/

In Clinic Optometrist Insertion of Dextenza ... In three Phase III randomized clinical studies, dexamethasone ophthalmic inserts were shown to be safe and effective for control of inflammation ...