Dry EyeNCT03691636
Eyelash Prostheses Compared to 5.0% Lifitegrast BID for Dry Eye Disease.
A study testing Eyelash prostheses and 5.0% Lifitegrast Ophthalmic Solution in people with Dry Eye, run by D.E.L., LLC at 1 site in United States.
Trial summary
This is a single-center, randomized, controlled trial to evaluate the safety and efficacy of eyelash prostheses versus 5.0% Lifitegrast BID, in 40 patients (20 randomized to each of two arms of the study) evaluated at 3 weeks and 5 weeks, respectively, after initiation of treatment. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Eyelash prostheses and 5.0% Lifitegrast Ophthalmic Solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2018to 1 May 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported dry eye symptoms
- Tear Break Up Time of less than 10 seconds as assessed by the Oculus Keratograph (see Appendix A).
- SPEED II Score greater than 25
- Men or Women, age between 50 and 90 inclusive
- Willingness to undergo both pre-treatment and post-treatment testing per the protocol
- Willingness to endure the 2-3 hour time required to place eyelash extensions, if randomized to this treatment arm
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- Willingness to use eye drops for dry eyes and fill a prescription through insurance coverage, if randomized to this treatment arm
- Willingness to attend all study visits
- Willingness to sign informed consent and liability waiver
- -
Who cannot join
- Absence of eyelashes
- Eyelash disease such as clinically significiant demodex, blepharitis, meibomitis
- Be unable or unwilling to give written informed consent and/or to comply with study procedures.
- Have any known hypersensitivity or contraindication to study treatments (including excipients), topical anesthetics or vital dyes.
- Be unable to demonstrate correct instillation of over the counter (OTC) ocular lubricant during Visit 1.
- Have clinically significant ocular surface disease in either eye (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with study safety procedures, or assessments.
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- Have clinically significant systemic disease (e.g., uncontrolled diabetes, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study at Visit 1 and 2.
- Current use of Restasis or Xiidra at the time of Visit 1
- Changes in the dose of, or the initiation of, any medications that are known to affect dry eyes within 90 days of Visit 1 or during the duration of the study.
- Any history of Herpes simplex of Herpes zoster affecting the eye or head.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Comprehensive Eye Care
Washington, Missouri, 63039
Michael Korenfeld, MD, 636-390-3999, michaelkorenfeld@hotmail.com
Michael Korenfeld, MD
About this study
Official title: A Single Center, Randomized, Controlled Trial Evaluating the Efficacy and Safety of Eyelash Prostheses Compared to 5.0% Lifitegrast Ophthalmic Solution in Subjects With Dry Eye Disease.
This is a single-center, randomized, controlled trial to evaluate the safety and efficacy of eyelash prostheses versus 5.0% Lifitegrast BID, in 40 patients (20 randomized to each of two arms of the study) evaluated at 3 weeks and 5 weeks, respectively, after initiation of treatment.
Read the detailed description
This is a single center, randomized, controlled clinical trial to evaluate the tolerability, efficacy, and safety of eyelash prostheses over a 3-week period versus Xiidra BID over a 5 week period in subjects with self-reported DED. 40 subjects will be randomized to either eyelash prostheses or Xiidra, in a 1:1 ratio.
At Visit 1 (screening), informed consent will be obtained from subjects and eligibility will then be determined. All pre-treatment assessments will be done at this visit. Randomization will occur. If randomized to receive Xiidra eye drops, a prescription will be written and the treatment will be started right away. If randomized to eyelash prostheses, then a second study visit will be made approximately 2 weeks later.
Visit 2 (Eyelash Prostheses application) Subjects randomized to receive eyelash prostheses will have them applied approximately 2 weeks after the screening and randomization visit.
Visit 3 (Final visit) will be 3 weeks post eyelash prosthesis placement and 5 weeks post Xiidra eye drop initiation. This was done to compare the maximal treatment effect between the two groups. All subjects will undergo post-treatment assessments.
At each visit, patients will be asked to report any adverse events.
- Conditions
- Dry Eye
- Being tested
- Eyelash prostheses, 5.0% Lifitegrast Ophthalmic Solution
- 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.
Eyelash prosthesesDevice
Eyelash prostheses are essentially specialized eyelash extensions
5.0% Lifitegrast Ophthalmic SolutionDevice
5.0% Lifitegrast Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| Eyelash Prostheses | Experimental | Each subject in this arm will receive eyelash prostheses according to a specified algorithm by a certified eyelash extensions. Receives: Device: Eyelash prostheses |
| 5.0% Lifitegrast Ophthalmic Solution | Active comparator | Each subject in this arm will receive 5.0% Lifitegrast eye drops BID Receives: Device: 5.0% Lifitegrast Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferior change from baseline in tear break up time as measured by the Oculus Keratograph in the interventional subjects compared to the active control subjects
A non-inferiority endpoint in tear break up time
Measured: The primary endpoint will be assessed 3 weeks after eyelash prosthesis placement in the interventional arm and 5 weeks after initiation of eye drops in the active comparator arm
Secondary outcomes (2)
Non-inferior change in tear meniscus height as measured by the Oculus Keratograph in the treatment subjects compared to control subjects
Non-inferiority endpoint in tear meniscus height
Measured: The secondary endpoint will be assessed 3 weeks after eyelash prosthesis placement in the interventional arm and the interventional arm and 5 weeks after initiation of eye drops in the active comparator arm
Non-inferior change from baseline in SPEED II questionnaire in the treatment subjects compared to the control subjects
Non-inferiority endpoint in the SPEED II questionnaire
Measured: The secondary endpoint will be assessed 3 weeks after eyelash prosthesis placement in the interventional arm and the interventional arm and 5 weeks after initiation of eye drops in the active comparator arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start2 Oct 2018 (estimated)
- Primary completion2 Apr 2019 (estimated)
- Study completion1 May 2019 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D.E.L., LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Korenfeld, MD, Principal investigator, Comprehensive Eye Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691636
- Sponsor's protocol ID
- D.E.L. 002
- Status last verified
- Sep 2018
- First submitted
- 28 Sep 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Controlled Trial Evaluating the Efficacy and Safety of Eyelash Prostheses Compared to 5.0% Lifitegrast Ophthalmic Solution in Subjects With Dry Eye Disease.
- ClinicalTrials.gov ID
- NCT03691636
- Acronym / sponsor ID
- D.E.L. 002
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- D.E.L., LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2018 (estimated)
- Primary completion
- 2 Apr 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 2 Oct 2018 (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.
This is a single-center, randomized, controlled trial to evaluate the safety and efficacy of eyelash prostheses versus 5.0% Lifitegrast BID, in 40 patients (20 randomized to each of two arms of the study) evaluated at 3 weeks and 5 weeks, respectively, after initiation of treatment.
Detailed description
This is a single center, randomized, controlled clinical trial to evaluate the tolerability, efficacy, and safety of eyelash prostheses over a 3-week period versus Xiidra BID over a 5 week period in subjects with self-reported DED. 40 subjects will be randomized to either eyelash prostheses or Xiidra, in a 1:1 ratio.
At Visit 1 (screening), informed consent will be obtained from subjects and eligibility will then be determined. All pre-treatment assessments will be done at this visit. Randomization will occur. If randomized to receive Xiidra eye drops, a prescription will be written and the treatment will be started right away. If randomized to eyelash prostheses, then a second study visit will be made approximately 2 weeks later.
Visit 2 (Eyelash Prostheses application) Subjects randomized to receive eyelash prostheses will have them applied approximately 2 weeks after the screening and randomization visit.
Visit 3 (Final visit) will be 3 weeks post eyelash prosthesis placement and 5 weeks post Xiidra eye drop initiation. This was done to compare the maximal treatment effect between the two groups. All subjects will undergo post-treatment assessments.
At each visit, patients will be asked to report any adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Eyelash Prostheses | Experimental | Device: Eyelash prosthesesEach subject in this arm will receive eyelash prostheses according to a specified algorithm by a certified eyelash extensions. |
| 5.0% Lifitegrast Ophthalmic Solution | Active comparator | Device: 5.0% Lifitegrast Ophthalmic SolutionEach subject in this arm will receive 5.0% Lifitegrast eye drops BID |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Self-reported dry eye symptoms
- Tear Break Up Time of less than 10 seconds as assessed by the Oculus Keratograph (see Appendix A).
- SPEED II Score greater than 25
- Men or Women, age between 50 and 90 inclusive
- Willingness to undergo both pre-treatment and post-treatment testing per the protocol
Key exclusion criteria (11 listed)
- Absence of eyelashes
- Eyelash disease such as clinically significiant demodex, blepharitis, meibomitis
- Be unable or unwilling to give written informed consent and/or to comply with study procedures.
- Have any known hypersensitivity or contraindication to study treatments (including excipients), topical anesthetics or vital dyes.
- Be unable to demonstrate correct instillation of over the counter (OTC) ocular lubricant during Visit 1.
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 |
|---|---|---|
| Eyelash prosthesesEyelash prostheses are essentially specialized eyelash extensions | Device | Eyelash Prostheses |
| 5.0% Lifitegrast Ophthalmic Solution5.0% Lifitegrast Ophthalmic Solution | Device | 5.0% Lifitegrast Ophthalmic Solution |
Primary outcome
Non-inferior change from baseline in tear break up time as measured by the Oculus Keratograph in the interventional subjects compared to the active control subjects
Time frame: The primary endpoint will be assessed 3 weeks after eyelash prosthesis placement in the interventional arm and 5 weeks after initiation of eye drops in the active comparator arm
A non-inferiority endpoint in tear break up time
2 secondary outcomes
Non-inferior change in tear meniscus height as measured by the Oculus Keratograph in the treatment subjects compared to control subjects
Time frame: The secondary endpoint will be assessed 3 weeks after eyelash prosthesis placement in the interventional arm and the interventional arm and 5 weeks after initiation of eye drops in the active comparator arm
Non-inferior change from baseline in SPEED II questionnaire in the treatment subjects compared to the control subjects
Time frame: The secondary endpoint will be assessed 3 weeks after eyelash prosthesis placement in the interventional arm and the interventional arm and 5 weeks after initiation of eye drops in the active comparator arm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Individual participant dataSharing planned: No. There is no plan to share data
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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.
Michael Korenfeld, MD principal investigator
Comprehensive Eye Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eyelash prostheses and 5.0% Lifitegrast Ophthalmic Solution in people with Dry Eye, run by D.E.L., LLC 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 10 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 2 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nancy M Holekamp, MD (314-378-9552, nholekamp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferior change from baseline in tear break up time as measured by the Oculus Keratograph in the interventional subjects compared to the active control subjects (time frame: The primary endpoint will be assessed 3 weeks after eyelash prosthesis placement in the interventional arm and 5 weeks after initiation of eye drops in the active comparator arm). 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 2 Oct 2018.