Dry EyeNCT04022382
A Study to Evaluate the Safety and Effectiveness Assessments of Restylane-Defyne for Punctual Occlusion
A study testing Restylane Defyne in people with Dry Eye, run by John C Meyer, MD at 1 site in United States.
Trial summary
A study which participants with mild to moderate dry eye disease will have a punctum of one eye injected with 0.1ml Restylane Defyne and the other eye injected with 0.2ml Restylane Defyne. Participants will be evaluated over four visits. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Restylane Defyne
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2019to 26 Aug 2019
- Phase
- Interventional
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21 to 80 years of age
- Baseline OSDI score of at least 13 with no more than 3 responses of "not applicable"
- In both eyes, a baseline Schirmer test with anesthetic of ≤ 10mm/5 minutes
- Literate, able to speak English and able to complete the questionnaire independently
- Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol.
Who cannot join
- Use of ophthalmic cyclosporine or lifitegrast within 30 days prior to Day 0
- History of surgical punctal occlusion (e.g., cautery), canalicular infection or canalicular surgery
- Corneal transplant in either eye
- Ocular surgery (such as cataract surgery or LASIK) in either eye within six months of the Baseline Visit
- A systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease)
- The history or presence of any ocular disorder or condition in either eye that, in the opinion of the investigator, would interfere with the interpretation of the study results (e.g., significant corneal or conjunctival scarring, pterygium or nodular pinguecula; current ocular infection (except mild blepharitis), conjunctivitis or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; history of ocular herpetic infection; evidence of keratoconus; lid or lacrimal cancer.
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- Active severe systemic allergy, seasonal allergies, rhinitis or sinusitis requiring changes in treatment within 30 days prior to the study or likely to require changes in treatment during the course of the study (i.e. antihistamines, decongestants, oral, topical or aerosol steroids)
- Participation in a clinical trial during the past 30 days
- Women who are pregnant, planning a pregnancy, or nursing at study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Arm, Single-Center, Randomized, Single-Masked Study to Evaluate Restylane-Defyne for Punctal Occlusion in Participants With Mild to Moderate Dry Eye Disease
A study which participants with mild to moderate dry eye disease will have a punctum of one eye injected with 0.1ml Restylane Defyne and the other eye injected with 0.2ml Restylane Defyne. Participants will be evaluated over four visits.
- Conditions
- Dry Eye
- Being tested
- Restylane Defyne
- Keywords
- Dry Eye Disease, Restylane-Defyne
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane DefyneDevice
Restylane is a gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL.
| Study group | Role | What they receive |
|---|---|---|
| Restylane Defyne recipient | Experimental | Not described Receives: Device: Restylane Defyne |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating change in Schirmer score from baseline.
Maximum length of tears absorbed on test strips recorded.
Measured: 30 days
Secondary outcomes (5)
Evaluating change in OSDI score.
Participants answer 12 question questionnaire. Scores from section I,II, and III.
Measured: 30 Days
Evaluating change in corneal staining score.
1.0mg sodium fluorescein strips on lower eye lids for one minute. 5 corneal regions graded using cobalt filter to maximized view of fluorescence.
Measured: 30 Days
Evaluating change in dye disappearance test.
Measured: 30 days
Evaluating change in tear break-up time.
Performed by Keratograph 5M per manufacturer's directions.
Measured: 30 days
Evaluating change in tear meniscus height.
Performed by Keratograph 5M per manufacturer's directions.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start18 Jul 2019
- Primary completion26 Aug 2019
- Study completion26 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- John C Meyer, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John C Meyer, MD, The Eye Care Institute
- Investigators
- John C Meyer, MD, Principal investigator, The Eye Care Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022382
- Sponsor's protocol ID
- 0619
- Status last verified
- Sep 2019
- First submitted
- 15 Jul 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Single-Center, Randomized, Single-Masked Study to Evaluate Restylane-Defyne for Punctal Occlusion in Participants With Mild to Moderate Dry Eye Disease
- ClinicalTrials.gov ID
- NCT04022382
- Acronym / sponsor ID
- 0619
- Conditions
- Dry Eye
- Keywords
- Dry Eye Disease, Restylane-Defyne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- John C Meyer, MDUniversity, hospital or other
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 17 Jul 2019 (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.
A study which participants with mild to moderate dry eye disease will have a punctum of one eye injected with 0.1ml Restylane Defyne and the other eye injected with 0.2ml Restylane Defyne. Participants will be evaluated over four visits.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restylane Defyne recipient | Experimental | Device: Restylane Defyne |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 21 to 80 years of age
- Baseline OSDI score of at least 13 with no more than 3 responses of "not applicable"
- In both eyes, a baseline Schirmer test with anesthetic of ≤ 10mm/5 minutes
- Literate, able to speak English and able to complete the questionnaire independently
- Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol.
Key exclusion criteria (9 listed)
- Use of ophthalmic cyclosporine or lifitegrast within 30 days prior to Day 0
- History of surgical punctal occlusion (e.g., cautery), canalicular infection or canalicular surgery
- Corneal transplant in either eye
- Ocular surgery (such as cataract surgery or LASIK) in either eye within six months of the Baseline Visit
- A systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease)
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 |
|---|---|---|
| Restylane DefyneRestylane is a gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL. | Device | Restylane Defyne recipient |
Primary outcome
Evaluating change in Schirmer score from baseline.
Time frame: 30 days
Maximum length of tears absorbed on test strips recorded.
5 secondary outcomes
Evaluating change in OSDI score.
Time frame: 30 Days
Evaluating change in corneal staining score.
Time frame: 30 Days
Evaluating change in dye disappearance test.
Time frame: 30 days
Evaluating change in tear break-up time.
Time frame: 30 days
Evaluating change in tear meniscus height.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Individual participant dataSharing planned: No
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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.
John C Meyer, MD principal investigator
The Eye Care Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Defyne in people with Dry Eye, run by John C Meyer, MD at 1 site in United States.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluating change in Schirmer score from baseline. (time frame: 30 days). 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 6 Sep 2019.