Eyelash Prostheses Compared to 5.0% Lifitegrast BID for Dry Eye Disease.
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|ClinicalTrials.gov Identifier: NCT03691636|
Recruitment Status : Unknown
Verified September 2018 by D.E.L., LLC.
Recruitment status was: Recruiting
First Posted : October 2, 2018
Last Update Posted : October 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye||Device: Eyelash prostheses Device: 5.0% Lifitegrast Ophthalmic Solution||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective randomized clinical trial|
|Masking:||None (Open Label)|
|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.|
|Estimated Study Start Date :||October 2, 2018|
|Estimated Primary Completion Date :||April 2, 2019|
|Estimated Study Completion Date :||May 1, 2019|
Experimental: Eyelash Prostheses
Each subject in this arm will receive eyelash prostheses according to a specified algorithm by a certified eyelash extensions.
Device: Eyelash prostheses
Eyelash prostheses are essentially specialized eyelash extensions
Active Comparator: 5.0% Lifitegrast Ophthalmic Solution
Each subject in this arm will receive 5.0% Lifitegrast eye drops BID
Device: 5.0% Lifitegrast Ophthalmic Solution
5.0% Lifitegrast Ophthalmic Solution
- 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
- 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-inferiority endpoint in tear meniscus height
- 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 ]Non-inferiority endpoint in the SPEED II questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691636
|Contact: Nancy M Holekamp, MDfirstname.lastname@example.org|
|Contact: Michael Korenfeld, MDemail@example.com|
|United States, Missouri|
|Comprehensive Eye Care||Recruiting|
|Washington, Missouri, United States, 63039|
|Contact: Michael Korenfeld, MD 636-390-3999 firstname.lastname@example.org|
|Principal Investigator: Michael Korenfeld, MD|
|Sub-Investigator: Rita Hindmon|
|Principal Investigator:||Michael Korenfeld, MD||Comprehensive Eye Care|