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

NCT ID: NCT03691636

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-02
• Study Completion Date: 2019-05-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Eyelash Prostheses

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

Group Type: EXPERIMENTAL

Eyelash prostheses

Intervention Type: DEVICE

Eyelash prostheses are essentially specialized eyelash extensions

5.0% Lifitegrast Ophthalmic Solution

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

Group Type: ACTIVE_COMPARATOR

5.0% Lifitegrast Ophthalmic Solution

Intervention Type: DEVICE

5.0% Lifitegrast Ophthalmic Solution

Interventions

Eyelash prostheses

Eyelash prostheses are essentially specialized eyelash extensions

Intervention Type: DEVICE

5.0% Lifitegrast Ophthalmic Solution

5.0% Lifitegrast Ophthalmic Solution

Intervention Type: DEVICE

Eligibility Criteria

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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• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

D.E.L., LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Korenfeld, MD

Role: PRINCIPAL_INVESTIGATOR

Comprehensive Eye Care

Locations

Comprehensive Eye Care

Washington, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nancy M Holekamp, MD

Role: CONTACT

nholekamp@gmail.com

314-378-9552

Michael Korenfeld, MD

Role: CONTACT

michaelkorenfeld@hotmail.com

636-390-3999

Facility Contacts

Michael Korenfeld, MD

Role: primary

michaelkorenfeld@hotmail.com

636-390-3999

Other Identifiers

D.E.L. 002

Identifier Type: -

Identifier Source: org_study_id