NCT05626478CompletedPhase 4
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt in Conjunction With Topical Drop Regimen Treating Pain and inflamMation Following Cataract Surgery Compared to SOC Topical Drop Regimen
Source: ClinicalTrials.gov · Last updated 20 Feb 2026
Brief summary (registry, in English)
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 8 Nov 2022
- Start date
- 1 Jun 2023
- Primary completion date
- 5 Feb 2025
- Lead sponsor
- Nicole Fram M.D.
- NCT number
- NCT05626478
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 50
- From 1 Jun 2023 to the primary completion date, 5 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Are currently being treated with immunomodulating agents in the study eye
- Are currently being treated with immunosuppressants and/or oral steroids
- Are currently being treated with corticosteroid implant (i.e Ozurdex)
- Currently using topical ophthalmic steroid medications
Other illness
- Have active infectious systemic disease
- Have active infectious ocular or extraocular disease
- Have known hypersensitivity to dexamethasone or are a known steroid responder
- Have a history of ocular inflammation or macular edema
- Has history of Laser Vision Correction (LASIK, PhotoRefractive Keratectomy) in the operated eye
- Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye
- Have a history of complete punctal occlusion in one or both punctum
- Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment
Age
- Under the age of 18 at the time of signing the Informed Consent Form
Other
- Pregnant or planning to become pregnant during the trial period
- Have visual acuity potential of less than 20/30 as recorded by a Retinal Acuity Meter or Potential Acuity Meter glare testing
- Have punctal plug in the study eye
- Have obstructed nasolacrimal duct in the study eye(s) (dacryocystitus)
- Are unwilling or unable to comply with the study protocol
Who the study is looking for
- 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
- Are willing and able to comply with clinic visits and study related procedures
- Are willing and able to sign the informed consent form
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Advanced Vision Care Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.