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

NCT04839549 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: The ROSE Study
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ocular Rosacea

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in tear breakup time

  Accessed at all time points (Day -30 - day -1, week 4, week 8)

• Change in Expression of Gland Scale

  Accessed at all time points (Day -30 - day -1, week 4, week 8)

• Change in corneal staining

  Accessed at all time points (Day -30 - day -1, week 4, week 8)

Study Arms (2)

Dextenza (Intracanalicular ) 0.4mg

EXPERIMENTAL

Dextenza for the treatment of Ocular Rosacea

Drug: Dextenza 0.4Mg Ophthalmic Insert

Fluoromethalone .01%

ACTIVE COMPARATOR

Fluoromethalone .1% BID for 2 weeks then once daily for 2 weeks for the treatment of Ocular Rosacea

Drug: Fluoromethalone .01%

Interventions

Dextenza 0.4Mg Ophthalmic Insert DRUG

Dextenza 0.4Mg Ophthalmic Insert

Dextenza (Intracanalicular ) 0.4mg

Fluoromethalone .01% DRUG

Fluoromethalone .01%

Fluoromethalone .01%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eye Associates of Central Texas: lead

MeSH Terms

Conditions

Rosacea

Interventions

Calcium Dobesilate

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: April 9, 2021
• Study Start: June 6, 2020
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share