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

NCT03691636 | Unknown FDA Device

• 1 other identifier: D.E.L. 002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Non-inferior change in tear meniscus height as measured by the Oculus Keratograph in the treatment subjects compared to control subjects

  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

  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

Study Arms (2)

Eyelash Prostheses

EXPERIMENTAL

Each subject in this arm will receive eyelash prostheses according to a specified algorithm by a certified eyelash extensions.

Device: Eyelash prostheses

5.0% Lifitegrast Ophthalmic Solution

ACTIVE COMPARATOR

Each subject in this arm will receive 5.0% Lifitegrast eye drops BID

Device: 5.0% Lifitegrast Ophthalmic Solution

Interventions

Eyelash prostheses DEVICE

Eyelash prostheses are essentially specialized eyelash extensions

Eyelash Prostheses

5.0% Lifitegrast Ophthalmic Solution DEVICE

5.0% Lifitegrast Ophthalmic Solution

5.0% Lifitegrast Ophthalmic Solution

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• D.E.L., LLC: lead

Study Sites (1)

Comprehensive Eye Care

Washington, Missouri, 63039, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Michael Korenfeld, MD

  Comprehensive Eye Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy M Holekamp, MD

CONTACT

314-378-9552; nholekamp@gmail.com

Michael Korenfeld, MD

CONTACT

636-390-3999; michaelkorenfeld@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective randomized clinical trial

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 2, 2018
• Study Start: October 2, 2018
• Primary Completion: April 2, 2019
• Study Completion: May 1, 2019
• Last Updated: October 2, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)