Back to resultsTreatment of Meibomian Gland Dysfunction and Dry Eye in Contact Lens Wearers
Primary Purpose
Meibomian Gland Dysfunction, Dry Eye
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
LipiFlow treatment
Sponsored by
About this trial
This is an interventional treatment trial for Meibomian Gland Dysfunction
Eligibility 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
Sites / Locations
- School of Optometry, The University of Alabama at Birmingham
- Clayton Eye Center
- Charlotte Eye Ear Nose and Throat Associates, P.A.
- May Eye Care Center & Associates
- Specialty Eyecare Group
- Centre for Contact Lens Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
Experimental
Arm Label
LipiFlow
Untreated Control
Crossover LipiFlow Treatment
Arm Description
Single 12-minute LipiFlow treatment
Untreated Control (No Intervention)
Crossover LipiFlow treatment of the untreated control group after 3 months
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Mean Change in Dry Eye Questionnaire Score From Baseline at 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02102464
Brief Title
Treatment of Meibomian Gland Dysfunction and Dry Eye in Contact Lens Wearers
Official Title
Pilot Study for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye in Contact Lens Wearers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TearScience, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction, Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LipiFlow
Arm Type
Experimental
Arm Description
Single 12-minute LipiFlow treatment
Arm Title
Untreated Control
Arm Type
No Intervention
Arm Description
Untreated Control (No Intervention)
Arm Title
Crossover LipiFlow Treatment
Arm Type
Experimental
Arm Description
Crossover LipiFlow treatment of the untreated control group after 3 months
Intervention Type
Device
Intervention Name(s)
LipiFlow treatment
Other Intervention Name(s)
LipiFlow® Thermal Pulsation System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Change in Meibomian Gland Score From Baseline at 3 Months
Description
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.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months
Description
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.
Time Frame
3 Months
Other Pre-specified Outcome Measures:
Title
Mean Change in Comfortable Contact Lens Wear Time From Baseline at 3 Months
Description
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.
Time Frame
3 Months
Title
Mean Change in Meibomian Gland Score From Baseline at 1 Month
Description
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.
Time Frame
1 Month
Title
Mean Change in Dry Eye Questionnaire From Baseline at 1 Month
Description
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.
Time Frame
1 Month
Title
Mean Change in Comfortable Contact Lens Wear Time From Baseline at 1 Month
Description
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.
Time Frame
1 Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christy Coleman, OD, MPH
Organizational Affiliation
TearScience, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
School of Optometry, The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Clayton Eye Center
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Charlotte Eye Ear Nose and Throat Associates, P.A.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
May Eye Care Center & Associates
City
Hanover
State/Province
Pennsylvania
ZIP/Postal Code
17331
Country
United States
Facility Name
Specialty Eyecare Group
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Centre for Contact Lens Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Treatment of Meibomian Gland Dysfunction and Dry Eye in Contact Lens Wearers
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