Treatment of Meibomian Gland Dysfunction and Dry Eye in Contact Lens Wearers

NCT02102464 | Completed Results

• 1 other identifier: LF006
• Study Type: interventional
• Target: 55
• Locations: 2 countries
• Sites: 6

Brief Summary

The pilot study objective is to evaluate the potential benefits of LipiFlow® System treatment of contact lens wearers with meibomian gland dysfunction and evaporative dry eye by assessing for improvement in meibomian gland function and reduction of dry eye symptoms in comparison to an untreated control.

Conditions

Meibomian Gland Dysfunction; Dry Eye

Outcome Measures

Primary Outcomes (1)

• Mean Change in Meibomian Gland Score From Baseline at 3 Months

  The Primary Endpoint was intended to assess for improvement in meibomian gland function in symptomatic contact lens wearers after LipiFlow treatment in comparison to an untreated control.The Primary Endpoint was defined as the mean change in meibomian gland score in the LipiFlow Treatment group compared to Untreated Control group from Baseline to 3 Months. To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction.

  3 Months

Secondary Outcomes (1)

• Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months

  3 Months

Other Outcomes (4)

• Mean Change in Comfortable Contact Lens Wear Time From Baseline at 3 Months

  3 Months

• Mean Change in Meibomian Gland Score From Baseline at 1 Month

  1 Month

• Mean Change in Dry Eye Questionnaire From Baseline at 1 Month

  1 Month

Study Arms (3)

LipiFlow

EXPERIMENTAL

Single 12-minute LipiFlow treatment

Device: LipiFlow treatment

Untreated Control

NO INTERVENTION

Untreated Control (No Intervention)

Crossover LipiFlow Treatment

EXPERIMENTAL

Crossover LipiFlow treatment of the untreated control group after 3 months

Device: LipiFlow treatment

Interventions

LipiFlow treatment DEVICE

The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.

Also known as: LipiFlow® Thermal Pulsation System

Crossover LipiFlow Treatment; LipiFlow

Eligibility Criteria

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

You may qualify if:

• Diagnosis of meibomian gland dysfunction and dry eye
• At least 18 years of age
• Willing to comply with randomization, attend all study visits and follow patient instructions
• Habitual soft contact lens wearer 2 to 18 hours/day and 4 to 7 days/week
• No change in contact lens type or dimensions for the past 3 months
• Clinician assessment of acceptable contact lens fit and disinfecting solution
• Tear film interferometry of 100 units or less

You may not qualify if:

• Systemic disease conditions that cause dry eye
• Use of systemic medications known to cause dryness
• History of any of the following ocular conditions in the past 3 months: surgery, trauma, Herpes infection, recurrent inflammation, punctal plug insertion or punctal occlusion
• Presence of any of the following active conditions: ocular infection, ocular inflammation, moderate to severe allergic conjunctivitis, severe eyelid inflammation, eyelid abnormality that affects lid function, or ocular surface abnormality that compromises corneal integrity
• Use of other treatments for meibomian gland dysfunction or dry eye except over the counter lubricants or dietary supplements
• Participation in another ophthalmic drug or device trial in the past month
• Employee, relative of employee or associate of the clinical site

Sponsors & Collaborators

• TearScience, Inc.: lead

Study Sites (6)

School of Optometry, The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Clayton Eye Center

Morrow, Georgia, 30260, United States

Location

Charlotte Eye Ear Nose and Throat Associates, P.A.

Charlotte, North Carolina, 28210, United States

Location

May Eye Care Center & Associates

Hanover, Pennsylvania, 17331, United States

Location

Specialty Eyecare Group

Kirkland, Washington, 98034, United States

Location

Centre for Contact Lens Research

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Results Point of Contact

• Title: VP Clinical and Regulatory Affairs
• Organization: TearScience, Inc.

regulatory@tearscience.com

919-467-4007

Study Officials

• Christy Coleman, OD, MPH

  TearScience, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 30, 2014
• First Posted: April 3, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 18, 2017
• Results First Posted: September 18, 2017

Record last verified: 2017-09

Locations

US (5); CA (1)