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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ocular Rosacea

Intervention / Treatment
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* Drug: Dextenza 0.4Mg Ophthalmic Insert
* Drug: Fluoromethalone .01%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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) |