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)

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.

Study Overview

• Status: Withdrawn
• Conditions: Ocular Rosacea
• Intervention / Treatment: Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Fluoromethalone .01%

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 insertion of the Dextenza insert)
• Have known history of herpetic eye disease (either active or historical)
• Have a history of refractive surgery within the past 2 years
• Have a history of retinal detachment, diabetic retinopathy, or active retinal disease
• Is currently (within the past 7 days) using an ophthalmic steroid preparation (drop, ointment or insert form)
• Is currently using ocular, topical, or systemic non-steroidal anti-inflammatory drugs (NSAIDs) - Baby aspirin (81mg) is allowed as long as a stable dose has been maintained for at least 30 days prior to Dextenza insertion and will continue to be maintained for the duration of the study
• Have an active infectious disease or is currently taking (or has taken within 7 days of initiation into the study) oral antibiotics
• Is actively being treated with local or systemic immunosuppression, including systemic steroids
• Have a planned ocular or systemic surgery within 30 days of the placement of the Dextenza insert.
• Have used a study drug or participated in a clinical study within 30 days of the beginning of this study
• Is currently pregnant, planning to become pregnant, or breastfeeding
• Is an employee or direct family member of an employee at the clinic site
• Have a diagnosis of any significant uncontrolled illness
• Have a history of alcohol or drug abuse in the past year
• Is a current smoker
• Have used an investigational drug or medical device within 30 days of the study or be concurrently enrolled in another investigational product trial
• Have an intraocular pressure that is less than 5mmHg or greater than 22mmHg or any type of glaucoma
• Is deemed unsafe for the study by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dextenza (Intracanalicular ) 0.4mg; Dextenza for the treatment of Ocular Rosacea	Drug: Dextenza 0.4Mg Ophthalmic Insert; Dextenza 0.4Mg Ophthalmic Insert
Active Comparator: Fluoromethalone .01%; Fluoromethalone .1% BID for 2 weeks then once daily for 2 weeks for the treatment of Ocular Rosacea	Drug: Fluoromethalone .01%; Fluoromethalone .01%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in OSDI	As measured by OSDI questionnaire	Accessed at all time points (Day -30 - day -1, week 4, week 8)
Patient preference in treatment therapy	As measured by Adapted COMTOL questionnaire	Accessed at Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in tear breakup time	As measured by Fluoroscein (Bioglo strip moistened with saline) placed in the inferior fornix of each eye. A cobalt blue light beam will be used to count the number of seconds between the last blink and the appearance of a dry spot or break in tear film.	Accessed at all time points (Day -30 - day -1, week 4, week 8)
Change in Expression of Gland Scale	As measured by digitally compressing the lower and upper lids and quantified on a 4-point scale: (0- all five glands, 1 - three to four glands, 2 - one to two glands, 3 - zero glands). The values will be averaged for each eye.	Accessed at all time points (Day -30 - day -1, week 4, week 8)
Change in corneal staining	As measured by the NEI/Industry Grading system	Accessed at all time points (Day -30 - day -1, week 4, week 8)

Collaborators and Investigators

• Sponsor: Eye Associates of Central Texas

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2020
• Primary Completion (Actual): November 29, 2022
• Study Completion (Actual): November 29, 2022

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Allergic Agents; Fluorometholone
• Other Study ID Numbers: The ROSE study (Other Identifier: Johns Hopkins University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No