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

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ClinicalTrials.gov Identifier: NCT02102464
Recruitment Status : Completed
First Posted : April 3, 2014
Results First Posted : September 18, 2017
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
TearScience, Inc.

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.

Condition or disease Intervention/treatment Phase
Meibomian Gland Dysfunction Dry Eye Device: LipiFlow treatment Not Applicable

Detailed Description:
This is a prospective, non-significant risk, open-label, randomized clinical trial of LipiFlow® treatment of contact lens wearers with meibomian gland dysfunction and evaporative dry eye. All subjects undergo examination to determine study eligibility and to capture the Baseline status. Subjects are randomized to receive LipiFlow® treatment (Treatment Group) or no LipiFlow® treatment (Untreated Control Group). The Treatment group is evaluated one month after receiving LipiFlow® treatment. Study endpoints are evaluated at 3 Months by comparing the Treatment Group to the Untreated Group. To facilitate subject recruitment, the Untreated Control group receives Crossover LipiFlow® treatment (Crossover Treatment Group) at 3 Months. The Crossover Treatment group is evaluated one month after receiving LipiFlow® treatment (4 Months visit).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye in Contact Lens Wearers
Study Start Date : April 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: LipiFlow
Single 12-minute LipiFlow treatment
Device: LipiFlow treatment
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.
Other Name: LipiFlow® Thermal Pulsation System

No Intervention: Untreated Control
Untreated Control (No Intervention)
Experimental: Crossover LipiFlow Treatment
Crossover LipiFlow treatment of the untreated control group after 3 months
Device: LipiFlow treatment
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.
Other Name: LipiFlow® Thermal Pulsation System




Primary Outcome Measures :
  1. Mean Change in Meibomian Gland Score From Baseline at 3 Months [ Time Frame: 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.


Secondary Outcome Measures :
  1. Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months [ Time Frame: 3 Months ]
    The Secondary Endpoint was intended to assess for reduction in dry eye symptoms in symptomatic contact lens after LipiFlow treatment in comparison to an untreated control using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. The Secondary Endpoint was defined as the mean change in SPEED score in the LipiFlow Treatment group compared to Untreated Control group from Baseline to 3 Months. Dry eye symptoms evaluated were dryness, grittiness or scratchiness; soreness or irritation; burning or watering; and eye fatigue. Symptom frequency and severity were assessed. The SPEED score is the sum of frequency and severity scores with a range from 0 to 28. A lower SPEED score represents less frequent and/or less severe symptoms.


Other Outcome Measures:
  1. Mean Change in Comfortable Contact Lens Wear Time From Baseline at 3 Months [ Time Frame: 3 Months ]
    Subjects reported how long they wore their contact lenses per day (total contact lens wear time) and how long the contact lenses were comfortable (comfortable contact lens wear time). A pre-specified exploratory analysis was to compare the mean change in comfortable contact lens wear time between Baseline and 3 Months for the LipiFlow group vs. untreated control.

  2. Mean Change in Meibomian Gland Score From Baseline at 1 Month [ Time Frame: 1 Month ]
    The mean change in meibomian gland score from Baseline was also evaluated at 1 Month post-LipiFlow treatment for the LipiFlow and Crossover LipiFlow Groups. The LipiFlow Group was assessed at the 1-Month visit. The Crossover LipiFlow Group was assessed at the 4-Month visit (one month after receiving crossover LipiFlow treatment). There was no planned statistical analysis comparison between the LipiFlow and Crossover LipiFlow groups at 1 Month. 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. Mean Change in Dry Eye Questionnaire From Baseline at 1 Month [ Time Frame: 1 Month ]
    The mean change in dry eye symptoms from Baseline based on the SPEED questionnaire score was also evaluated at 1 Month post-LipiFlow treatment for the LipiFlow and Crossover LipiFlow Groups. The LipiFlow Group was assessed at the 1-Month visit. The Crossover LipiFlow Group was assessed at the 4-Month visit (one month after receiving cossover LipiFlow treatment). There was no planned statistical analysis comparison between the LipiFlow and Crossover LipiFlow groups at 1 Month. Dry eye symptoms evaluated were dryness, grittiness or scratchiness; soreness or irritation; burning or watering; and eye fatigue. Symptom frequency and severity were assessed. The SPEED score is the sum of frequency and severity scores with a range from 0 to 28. A lower SPEED score represents less frequent and/or less severe symptoms.

  4. Mean Change in Comfortable Contact Lens Wear Time From Baseline at 1 Month [ Time Frame: 1 Month ]
    Subjects reported how long they wore their contact lenses per day (total contact lens wear time) and how long the contact lenses were comfortable (comfortable contact lens wear time). The mean change in comfortable contact lens wear time from Baseline was also evaluated at 1 Month post-LipiFlow treatment for the LipiFlow and Crossover LipiFlow Groups. The LipiFlow Group was assessed at the 1-Month visit. The Crossover LipiFlow Group was assessed at the 4-Month visit (one month after receiving cossover LipiFlow treatment). There was no planned statistical analysis comparison between the LipiFlow and Crossover LipiFlow groups at 1 Month.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102464


Locations
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United States, Alabama
School of Optometry, The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Georgia
Clayton Eye Center
Morrow, Georgia, United States, 30260
United States, North Carolina
Charlotte Eye Ear Nose and Throat Associates, P.A.
Charlotte, North Carolina, United States, 28210
United States, Pennsylvania
May Eye Care Center & Associates
Hanover, Pennsylvania, United States, 17331
United States, Washington
Specialty Eyecare Group
Kirkland, Washington, United States, 98034
Canada, Ontario
Centre for Contact Lens Research
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
TearScience, Inc.
Investigators
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Study Director: Christy Coleman, OD, MPH TearScience, Inc.

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Responsible Party: TearScience, Inc.
ClinicalTrials.gov Identifier: NCT02102464     History of Changes
Other Study ID Numbers: LF006
First Posted: April 3, 2014    Key Record Dates
Results First Posted: September 18, 2017
Last Update Posted: October 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases