Eyelash Prostheses Compared to 5.0% Lifitegrast BID for Dry Eye Disease.

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.

Study Overview

• Status: Unknown
• Conditions: Dry Eye
• Intervention / Treatment: Device: Eyelash prostheses; Device: 5.0% Lifitegrast Ophthalmic Solution

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Washington, Missouri, United States, 63039
      • Recruiting
      • Comprehensive Eye Care
      • Contact: Michael Korenfeld, MD; Phone Number: 636-390-3999; Email: michaelkorenfeld@hotmail.com
      • Sub-Investigator: Rita Hindmon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Self-reported dry eye symptoms
2. Tear Break Up Time of less than 10 seconds as assessed by the Oculus Keratograph (see Appendix A).
3. SPEED II Score greater than 25
4. Men or Women, age between 50 and 90 inclusive
5. Willingness to undergo both pre-treatment and post-treatment testing per the protocol
6. Willingness to endure the 2-3 hour time required to place eyelash extensions, if randomized to this treatment arm
7. Willingness to use eye drops for dry eyes and fill a prescription through insurance coverage, if randomized to this treatment arm
8. Willingness to attend all study visits

9. Willingness to sign informed consent and liability waiver

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Exclusion Criteria:

1. Absence of eyelashes
2. Eyelash disease such as clinically significiant demodex, blepharitis, meibomitis
3. Be unable or unwilling to give written informed consent and/or to comply with study procedures.
4. Have any known hypersensitivity or contraindication to study treatments (including excipients), topical anesthetics or vital dyes.
5. Be unable to demonstrate correct instillation of over the counter (OTC) ocular lubricant during Visit 1.
6. 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.
7. 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.
8. Current use of Restasis or Xiidra at the time of Visit 1
9. 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.

10. Any history of Herpes simplex of Herpes zoster affecting the eye or head.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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

Collaborators and Investigators

• Sponsor: D.E.L., LLC
• Investigators: Principal Investigator: Michael Korenfeld, MD, Comprehensive Eye Care

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 2, 2018
• Primary Completion (ANTICIPATED): April 2, 2019
• Study Completion (ANTICIPATED): May 1, 2019

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: October 1, 2018
• First Posted (ACTUAL): October 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 2, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions; Lifitegrast
• Other Study ID Numbers: D.E.L. 002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No