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

Primary Purpose

Dry Eye

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Eyelash prostheses

5.0% Lifitegrast Ophthalmic Solution

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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Exclusion Criteria:

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.
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Sites / Locations

Comprehensive Eye CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Eyelash Prostheses

5.0% Lifitegrast Ophthalmic Solution

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT03691636

First Posted

September 28, 2018

Last Updated

October 1, 2018

Sponsor

D.E.L., LLC

1. Study Identification

Unique Protocol Identification Number

NCT03691636

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 2, 2018 (Anticipated)

Primary Completion Date

April 2, 2019 (Anticipated)

Study Completion Date

May 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

D.E.L., LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Prospective randomized clinical trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Eyelash Prostheses

Arm Type

Experimental

Arm Description

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

Arm Title

5.0% Lifitegrast Ophthalmic Solution

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Eyelash prostheses

Intervention Description

Eyelash prostheses are essentially specialized eyelash extensions

Intervention Type

Device

Intervention Name(s)

5.0% Lifitegrast Ophthalmic Solution

Intervention Description

5.0% Lifitegrast Ophthalmic Solution

Primary Outcome Measure Information:

Title

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

Description

A non-inferiority endpoint in tear break up time

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

Secondary Outcome Measure Information:

Title

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

Description

Non-inferiority endpoint in tear meniscus height

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

Title

Non-inferior change from baseline in SPEED II questionnaire in the treatment subjects compared to the control subjects

Description

Non-inferiority endpoint in the SPEED II questionnaire

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 - Exclusion Criteria: 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. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nancy M Holekamp, MD

Phone

314-378-9552

nholekamp@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Michael Korenfeld, MD

Phone

636-390-3999

michaelkorenfeld@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Korenfeld, MD

Organizational Affiliation

Comprehensive Eye Care

Official's Role

Principal Investigator

Facility Information:

Facility Name

Comprehensive Eye Care

City

Washington

State/Province

Missouri

ZIP/Postal Code

63039

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Korenfeld, MD

Phone

636-390-3999

michaelkorenfeld@hotmail.com

First Name & Middle Initial & Last Name & Degree

Michael Korenfeld, MD

First Name & Middle Initial & Last Name & Degree

Rita Hindmon

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan to share data

Learn more about this trial

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

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