NCT04839549

Efficacy and Safety of Dextenza Compared to Topical Fluorometholone in Patients With Ocular Rosacea

Randomized, Open Label, Prospective Study on the Efficacy and Safety of Dextenza Compared to Topical Fluorometholone in Patients With Ocular Rosacea (ROSE Study)

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Eye Associates of Central Texas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Prospective Open-label Interventional Study Randomized, self-controlled design in which one eye receives Dextenza (Group A) intracanalicular insert and the contralateral eye receives topical fluorometholone 0.1% BID (Group B) for 2 weeks then once daily for 2 weeks for the treatment of ocular rosacea. All patients will be placed on oral doxycycline 100mg BID for one month and tapered to a maintenance dose of 100mg once daily for the remainder of the study. Patient evaluations will be performed at Screening/Baseline, Insertion Day, Month 1 and Month 2.

Conditions

• Ocular Rosacea

Interventions

Type	Name	Description
DRUG	Dextenza 0.4Mg Ophthalmic Insert	Dextenza 0.4Mg Ophthalmic Insert
DRUG	Fluoromethalone .01%	Fluoromethalone .01%

Timeline

• Start date: 2020-06-06
• Primary completion: 2022-11-29
• Completion: 2022-11-29
• First posted: 2021-04-09
• Last updated: 2023-06-18

Regulatory

• FDA-regulated drug study