Efficacy and Safety of Dextenza Compared to Topical Fluorometholone in Patients With Ocular Rosacea (NCT04839549) | Clinical Trial Compass
WithdrawnPhase 4
Efficacy and Safety of Dextenza Compared to Topical Fluorometholone in Patients With Ocular Rosacea
Stopped: Lack of patient enrollment
0Started 2020-06-06
Plain-language summary
To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to a standard steroid drop regimen in the contralateral eye for the treatment of ocular rosacea.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be at least 18 years of age, any gender or race
* Provide written informed consent
* Sign the HIPAA form
* Attend all study visits
* Take all study medications as directed
* Be willing to avoid all disallowed medications
* Be willing to avoid all contact lens wear between Dextenza insertion (Visit 2) and Post-op 1 month visit (Visit 3)
* Have a best-corrected visual acuity (BCVA) or greater than or equal to 50 ETDRS letters (20/100 Snellen equivalent) or better in each eye at the screening visit.
* For women of childbearing age (menarche to less than 12 months of menopause who have not undergone surgical sterilization), be willing to have a urine pregnancy test and agree to use a medically acceptable form of birth control throughout the study duration.
* Have a documented diagnosis of Ocular Rosacea and exhibit typical signs or symptoms associated with the diagnosis (irritation, burning, foreign body sensation, redness, itching, inflammation, dry eye, discharge)
Exclusion Criteria:
* Have any allergy or other historical contraindication to the medications in the protocol
* Is unable to use the study medications regularly as directed
* Have any other ocular disease that could affect the subject's ability to participate in the study safely (narrow angle glaucoma, iritis, current infection, elevated intraocular pressure, history of significant steroid response with and IOP \>22mmHg, punctal size less than 0.4mm or lid malformation that would preclude ins…
What they're measuring
1
Change in OSDI
Timeframe: Accessed at all time points (Day -30 - day -1, week 4, week 8)