search
Back to results

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

Primary Purpose

Ocular Rosacea

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dextenza 0.4Mg Ophthalmic Insert
Fluoromethalone .01%
Sponsored by
Eye Associates of Central Texas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Dextenza (Intracanalicular ) 0.4mg

    Fluoromethalone .01%

    Arm Description

    Dextenza for the treatment of Ocular Rosacea

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

    Outcomes

    Primary Outcome Measures

    Change in OSDI
    As measured by OSDI questionnaire
    Patient preference in treatment therapy
    As measured by Adapted COMTOL questionnaire

    Secondary Outcome Measures

    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.
    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.
    Change in corneal staining
    As measured by the NEI/Industry Grading system

    Full Information

    First Posted
    October 19, 2020
    Last Updated
    June 14, 2023
    Sponsor
    Eye Associates of Central Texas
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04839549
    Brief Title
    Efficacy and Safety of Dextenza Compared to Topical Fluorometholone in Patients With Ocular Rosacea
    Official Title
    Randomized, Open Label, Prospective Study on the Efficacy and Safety of Dextenza Compared to Topical Fluorometholone in Patients With Ocular Rosacea (ROSE Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of patient enrollment
    Study Start Date
    June 6, 2020 (Actual)
    Primary Completion Date
    November 29, 2022 (Actual)
    Study Completion Date
    November 29, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Eye Associates of Central Texas

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ocular Rosacea

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dextenza (Intracanalicular ) 0.4mg
    Arm Type
    Experimental
    Arm Description
    Dextenza for the treatment of Ocular Rosacea
    Arm Title
    Fluoromethalone .01%
    Arm Type
    Active Comparator
    Arm Description
    Fluoromethalone .1% BID for 2 weeks then once daily for 2 weeks for the treatment of Ocular Rosacea
    Intervention Type
    Drug
    Intervention Name(s)
    Dextenza 0.4Mg Ophthalmic Insert
    Intervention Description
    Dextenza 0.4Mg Ophthalmic Insert
    Intervention Type
    Drug
    Intervention Name(s)
    Fluoromethalone .01%
    Intervention Description
    Fluoromethalone .01%
    Primary Outcome Measure Information:
    Title
    Change in OSDI
    Description
    As measured by OSDI questionnaire
    Time Frame
    Accessed at all time points (Day -30 - day -1, week 4, week 8)
    Title
    Patient preference in treatment therapy
    Description
    As measured by Adapted COMTOL questionnaire
    Time Frame
    Accessed at Week 4
    Secondary Outcome Measure Information:
    Title
    Change in tear breakup time
    Description
    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.
    Time Frame
    Accessed at all time points (Day -30 - day -1, week 4, week 8)
    Title
    Change in Expression of Gland Scale
    Description
    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.
    Time Frame
    Accessed at all time points (Day -30 - day -1, week 4, week 8)
    Title
    Change in corneal staining
    Description
    As measured by the NEI/Industry Grading system
    Time Frame
    Accessed at all time points (Day -30 - day -1, week 4, week 8)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs