Recruiting

Lifitegrast

Sponsor:

D.E.L., LLC

Code:

NCT03691636

Conditions

Dry Eye

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Eyelash prostheses

5.0% Lifitegrast Ophthalmic Solution

Study Details

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

Study ID

NCT03691636

Start date

Oct 2, 2018

Status verified date

Sep, 2018

Completion date

May 1, 2019

Anticipated

Primary completion date

Apr 2, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Eyelash Prostheses

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

active comparator: 5.0% Lifitegrast Ophthalmic Solution

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

Interventions

Eyelash prostheses

Eyelash prostheses are essentially specialized eyelash extensions

5.0% Lifitegrast Ophthalmic Solution

5.0% Lifitegrast Ophthalmic Solution

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 ]

Central Contacts and Locations

Central contacts

Locations

Comprehensive Eye Care

Recruiting

Washington, Missouri, United States, 63039

Contacts

Principal Investigator:

Michael Korenfeld, MD

More Information

Sponsor

D.E.L., LLC

Last update posted

Oct 2, 2018

Last verified

Sep, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by D.E.L., LLC on 2018-10-02.