Ocular RosaceaPhase 4NCT04839549
Efficacy and Safety of Dextenza Compared to Topical Fluorometholone in Patients With Ocular Rosacea
A Phase 4 study testing Dextenza 0.4Mg Ophthalmic Insert and Fluoromethalone .01% in people with Ocular Rosacea, run by Eye Associates of Central Texas.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Rosacea
- What is being tested?
- Dextenza 0.4Mg Ophthalmic Insert and Fluoromethalone .01%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 Jun 2020to 29 Nov 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
About this study
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)
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.
Read the 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
- Being tested
- Dextenza 0.4Mg Ophthalmic Insert, Fluoromethalone .01%
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextenza 0.4Mg Ophthalmic InsertDrug
Dextenza 0.4Mg Ophthalmic Insert
Fluoromethalone .01%Drug
Fluoromethalone .01%
| Study group | Role | What they receive |
|---|---|---|
| Dextenza (Intracanalicular ) 0.4mg | Experimental | Dextenza for the treatment of Ocular Rosacea Receives: 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 Receives: Drug: Fluoromethalone .01% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in OSDI
As measured by OSDI questionnaire
Measured: Accessed at all time points (Day -30 - day -1, week 4, week 8)
Patient preference in treatment therapy
As measured by Adapted COMTOL questionnaire
Measured: Accessed at Week 4
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: Accessed at all time points (Day -30 - day -1, week 4, week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start6 Jun 2020
- Primary completion29 Nov 2022
- Study completion29 Nov 2022
Why it stopped: Lack of patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye Associates of Central Texas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lena Dixit, MD, Eye Associates of Central Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839549
- Sponsor's protocol ID
- The ROSE Study
- Status last verified
- Jun 2023
- First submitted
- 19 Oct 2020
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04839549
- Acronym / sponsor ID
- The ROSE Study
- Conditions
- Ocular Rosacea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of patient enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eye Associates of Central TexasUniversity, hospital or other
- Study start
- 6 Jun 2020 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dextenza (Intracanalicular ) 0.4mg | Experimental | Drug: Dextenza 0.4Mg Ophthalmic InsertDextenza for the treatment of Ocular Rosacea |
| Fluoromethalone .01% | Active comparator | Drug: Fluoromethalone .01%Fluoromethalone .1% BID for 2 weeks then once daily for 2 weeks for the treatment of Ocular Rosacea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextenza 0.4Mg Ophthalmic InsertDextenza 0.4Mg Ophthalmic Insert | Drug | Dextenza (Intracanalicular ) 0.4mg |
| Fluoromethalone .01%Fluoromethalone .01% | Drug | Fluoromethalone .01% |
Primary outcome
Change in OSDI
Time frame: Accessed at all time points (Day -30 - day -1, week 4, week 8)
As measured by OSDI questionnaire
Patient preference in treatment therapy
Time frame: Accessed at Week 4
As measured by Adapted COMTOL questionnaire
3 secondary outcomes
Change in tear breakup time
Time frame: Accessed at all time points (Day -30 - day -1, week 4, week 8)
Change in Expression of Gland Scale
Time frame: Accessed at all time points (Day -30 - day -1, week 4, week 8)
Change in corneal staining
Time frame: Accessed at all time points (Day -30 - day -1, week 4, week 8)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Ocular Rosacea
Enrolling by invitationPhase 2
Study of Lotilaner Ophthalmic Gel in Patients With Ocular Rosacea (KORE)
Ocular Rosacea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dextenza 0.4Mg Ophthalmic Insert and Fluoromethalone .01% in people with Ocular Rosacea, run by Eye Associates of Central Texas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in OSDI (time frame: Accessed at all time points (Day -30 - day -1, week 4, week 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.