Treatment of Meibomian Gland Dysfunction Prior to Cataract Surgery

Sponsor
TearScience, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01808560
Collaborator
(none)
34
Enrollment
7
Locations
3
Arms
22
Duration (Months)
4.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this pilot feasibility study is to assess whether treating meibomian gland dysfunction (MGD) prior to cataract surgery helps promote meibomian gland function, visual quality and ocular comfort after cataract surgery.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: LipiFlow Pre-Treatment
  • Device: LipiFlow Post-treatment
N/A

Detailed Description

This is a post-market, prospective, non-significant risk, open-label, randomized multi-center clinical trial evaluating treatment with the LipiFlow System in patients with meibomian gland dysfunction prior to planned bilateral cataract surgery. All subjects undergo examination to determine study eligibility and to capture the Baseline status prior to surgery. Subjects are randomized to receive LipiFlow treatment (Pre-treatment group) one month before cataract surgery or no LipiFlow treatment (Untreated Control group). Cataract surgery is performed on both eyes of each subject with the second eye surgery completed within two months of the first eye. All subjects are evaluated at one month and three months after cataract surgery on the second eye with comparison of the study endpoints between the Pre-treatment and Untreated groups. To facilitate subject recruitment, the Untreated Control group receives crossover LipiFlow treatment for MGD (Post-treatment group) three months after cataract surgery on the second eye.

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Study for Treatment of Meibomian Gland Dysfunction (MGD) Prior to Cataract Surgery
Study Start Date :
Mar 1, 2013
Actual Primary Completion Date :
Jan 1, 2015
Actual Study Completion Date :
Jan 1, 2015

Arms and Interventions

ArmIntervention/Treatment
Experimental: LipiFlow Pre-treatment

Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.

Device: LipiFlow Pre-Treatment
The LipiFlow Thermal Pulsation System is 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 Names:
  • LipiFlow Thermal Pulsation System
  • No Intervention: Untreated Control

    Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.

    Experimental: LipiFlow Post-treatment

    Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.

    Device: LipiFlow Post-treatment
    The LipiFlow Thermal Pulsation System is 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 Names:
  • LipiFlow Thermal Pulsation System
  • Outcome Measures

    Primary Outcome Measures

    1. Mean Change in Total Meibomian Gland Score [Baseline and 3 Months post-surgery]

      The primary endpoint is the mean change in total meibomian gland score in the Pre-treatment group compared to the Untreated group from Baseline after cataract surgery. Meibomian gland assessment was performed to evaluate the function of the meibomian glands based on the secretion characteristics from the gland orifices along the lower eyelid. Under a slit-lamp biomicrosope, the gland orifices were evaluated using a handheld instrument, Meibomian Gland Evaluator. This instrument provided a standardized method of applying the same amount of pressure and for each eye to ensure measurement consistency. A total of 15 glands 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 of 0 to 45.

    Secondary Outcome Measures

    1. Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months [Baseline and 3 Months post-surgery]

      Assess for reduction in dry eye symptoms in symptomatic contact lens after LipiFlow treatment in comparison to an untreated control using Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. It was defined as the mean change in SPEED score in the LF Treatment group compared to Control group from Baseline to 3 Months. The symptoms assessed are dryness, grittiness / scratchiness; soreness / irritation; burning / watering; and eye fatigue. Symptom frequency is on a scale of: 0 (never), 1(sometimes), 2 (often) and 3 (constant). Symptom severity is on a scale of: 0 (no problems), 1 (tolerable-not perfect but not uncomfortable), 2 (uncomfortable-irritating but does not interfere with my day), 3 (bothersome-irritating and interferes with my day) and 4 (intolerable-unable to perform my daily tasks). SPEED score is calculated as sum of frequency and severity scores for symptoms over 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 Ocular Surface Disease Index (OSDI) Questionnaire Score From Baseline at 3 Months [Baseline and 3 Months post-surgery]

      Dry eye symptoms assessed using the OSDI questionnaire are sensitivity to light, grittiness, pain or soreness, blurred vision and poor vision. The assessment considers the frequency that problems with the eyes limit performance in reading, driving at night, working with a computer or bank machine, and watching television. Also, the frequency that eyes feel uncomfortable is assessed in windy conditions, areas with low humidity, and air-conditioned areas. The frequency scale is: 0 (none of the time), 1 (some of the time), 2 (half of the time), 3 (most of the time) and 4 (all of the time). The subject can answer not applicable (N/A) if the subject did not experience the situation or condition in the past week. Total OSDI score is calculated as the sum of frequency scores for all symptoms multiplied by 25 and divided by the number of questions answered with a range from 0 to 100. A lower OSDI score represents less disability from dry eye symptoms.

    2. Mean Change in NEI-VFQ Questionnaire Score From Baseline at 3 Months [Baseline and 3 Months post-surgery]

      The National Eye Institute Visual Function Questionnaire (NEI-VFQ) evaluates frequency or severity of a symptoms and the effect on activities of daily living. The questionnaire has an overall score and 12 subscale scores for general health, general vision, ocular pain, difficulty with near vision activities, difficulty with distance vision activities, social functioning limitations due to vision, mental functioning limitations due to vision, role limitations due to vision, dependency on others due to vision, driving difficulties, color vision and peripheral vision. The NEI-VFQ scores range from 0 to 100 with lower scores indicating more symptoms or difficulty with activities of daily living. The questionnaire is scored by recoding responses to set values on a 0 to 100 scale such that the lowest value is set to 0 and the highest value is set to 100. The overall score is the average of vision subscale scores, excluding general health question.

    3. Mean Change in Number of MGYLS (Meibomian Glands Yielding Liquid Secretion) [Baseline and 3 Months post-surgery]

      Meibomian gland assessment was performed to evaluate the function of the meibomian glands based on the secretion characteristics from the gland orifices along the lower eyelid at the visits. Under a slit-lamp biomicrosope, the gland orifices were evaluated using a handheld instrument, Meibomian Gland Evaluator, to apply gentle pressure along the eyelid margin. This instrument provided a standardized method of applying the same amount of pressure at each visit and for each eye to ensure measurement consistency. The number of meibomian glands yielding liquid secretion (MGYLS) (i.e., cloudy or clear liquid with a grade of 2 or 3) was counted out of the 15 glands assessed with a range of 0 to 15. A higher total meibomian gland score or higher number of MGYLS reflects less meibomian gland dysfunction.

    4. Mean Change in Tear Break-up Time (TBUT) [Baseline and 3 Months post-surgery]

      The Investigator or designee measures tear break-up time (TBUT) under a slit-lamp biomicroscope following instillation of fluorescein dye in the eye using the Dry Eye Test (DET) method. Tear film break-up is defined as the first observed break-up of the tear film following the third blink. Using a stopwatch to record the time, start the stopwatch as soon as the subject opens his/her eyes after the third blink and stop the stopwatch when the first break-up of the tear film is observed. Any values recorded as greater than 20 seconds were converted to 20 seconds in the analysis. Three separate measurements were taken for each eye and were averaged for analysis. A higher tear break-up time indicates better tear film stability.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 55 to 85 years of age

    • Must be able to comply with protocol including study randomization; completion of planned bilateral cataract surgery; no use of other MGD or dry eye treatments during the study; and attendance at all study visits

    • Meibomian gland dysfunction in both eyes based on total meibomian gland score

    • None to mild dry eye symptoms based on Ocular Surface Disease Index score

    • Tear film interferometry assessment of 100 units or less

    Exclusion Criteria:
    • Systemic disease conditions that causes dry eye

    • Use of systemic medications known to cause dry eye

    • Use of other MGD or dry eye treatments except for over the counter lubricants or dietary supplements

    • 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

    • Participation in another ophthalmic drug or device trial in the past month

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Chicago Cornea Consultants, Ltd.Hoffman EstatesIllinoisUnited States60169
    2Jackson EyeLake VillaIllinoisUnited States60046
    3Charles River Eye AssociatesWinchesterMassachusettsUnited States01890
    4Associated Eye CareStillwaterMinnesotaUnited States55082
    5Ophthalmology Consultants, Ltd.Saint LouisMissouriUnited States63131
    6The May Eye Care CenterHanoverPennsylvaniaUnited States17833
    7Carolina EyeCare Physicians, LLCMount PleasantSouth CarolinaUnited States29464

    Sponsors and Collaborators

    • TearScience, Inc.

    Investigators

    • Study Director: Christy Stevens, OD, MPH, TearScience

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TearScience, Inc.
    ClinicalTrials.gov Identifier:
    NCT01808560
    Other Study ID Numbers:
    • LF005
    First Posted:
    Mar 11, 2013
    Last Update Posted:
    Sep 4, 2018
    Last Verified:
    Aug 1, 2018

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleLipiFlow Pre-treatmentUntreated ControlLipiFlow Post-treatment
    Arm/Group DescriptionSubjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery. LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is 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.Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery. LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is 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.
    Period Title: Randomization and Treatment Allocation
    STARTED18160
    COMPLETED18160
    NOT COMPLETED000
    Period Title: Randomization and Treatment Allocation
    STARTED16130
    COMPLETED16130
    NOT COMPLETED000
    Period Title: Randomization and Treatment Allocation
    STARTED17130
    COMPLETED17130
    NOT COMPLETED000
    Period Title: Randomization and Treatment Allocation
    STARTED0013
    COMPLETED0013
    NOT COMPLETED000
    Period Title: Randomization and Treatment Allocation
    STARTED0013
    COMPLETED0013
    NOT COMPLETED000

    Baseline Characteristics

    Arm/Group TitleLipiFlow Pre-treatmentUntreated ControlLipiFlow Post-treatmentTotal
    Arm/Group DescriptionSubjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery. LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is 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.Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery. LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is 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.Total of all reporting groups
    Overall Participants1816034
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    71.9
    (5.7)
    68.6
    (6.4)
    70.4
    (6.2)
    Sex: Female, Male (Count of Participants)
    Female
    13
    72.2%
    12
    75%
    25
    Infinity
    Male
    5
    27.8%
    4
    25%
    9
    Infinity
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    1
    5.6%
    0
    0%
    1
    Infinity
    Not Hispanic or Latino
    17
    94.4%
    16
    100%
    33
    Infinity
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    NaN
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    1
    6.3%
    1
    Infinity
    Asian
    0
    0%
    0
    0%
    0
    NaN
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    NaN
    Black or African American
    1
    5.6%
    0
    0%
    1
    Infinity
    White
    17
    94.4%
    15
    93.8%
    32
    Infinity
    More than one race
    0
    0%
    0
    0%
    0
    NaN
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    NaN

    Outcome Measures

    1. Primary Outcome
    TitleMean Change in Total Meibomian Gland Score
    DescriptionThe primary endpoint is the mean change in total meibomian gland score in the Pre-treatment group compared to the Untreated group from Baseline after cataract surgery. Meibomian gland assessment was performed to evaluate the function of the meibomian glands based on the secretion characteristics from the gland orifices along the lower eyelid. Under a slit-lamp biomicrosope, the gland orifices were evaluated using a handheld instrument, Meibomian Gland Evaluator. This instrument provided a standardized method of applying the same amount of pressure and for each eye to ensure measurement consistency. A total of 15 glands 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 of 0 to 45.
    Time FrameBaseline and 3 Months post-surgery

    Outcome Measure Data

    Analysis Population Description
    Intent to Treat (ITT) Population of all randomized subjects.
    Arm/Group TitleLipiFlow Pre-treatmentUntreated ControlLipiFlow Post-treatment
    Arm/Group DescriptionSubjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery. LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is 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.Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery. LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is 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.
    Measure Participants17130
    Measure Eyes34260
    Mean (Standard Deviation) [Change in Meibomian Gland Score]
    12.8
    (9.9)
    1.9
    (6.1)
    2. Secondary Outcome
    TitleMean Change in Dry Eye Questionnaire Score From Baseline at 3 Months
    DescriptionAssess for reduction in dry eye symptoms in symptomatic contact lens after LipiFlow treatment in comparison to an untreated control using Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. It was defined as the mean change in SPEED score in the LF Treatment group compared to Control group from Baseline to 3 Months. The symptoms assessed are dryness, grittiness / scratchiness; soreness / irritation; burning / watering; and eye fatigue. Symptom frequency is on a scale of: 0 (never), 1(sometimes), 2 (often) and 3 (constant). Symptom severity is on a scale of: 0 (no problems), 1 (tolerable-not perfect but not uncomfortable), 2 (uncomfortable-irritating but does not interfere with my day), 3 (bothersome-irritating and interferes with my day) and 4 (intolerable-unable to perform my daily tasks). SPEED score is calculated as sum of frequency and severity scores for symptoms over a range from 0 to 28. A lower SPEED score represents less frequent and/or less severe symptoms.
    Time FrameBaseline and 3 Months post-surgery

    Outcome Measure Data

    Analysis Population Description
    Intent to Treat (ITT) Population of all randomized subjects.
    Arm/Group TitleLipiFlow Pre-treatmentUntreated ControlLipiFlow Post-treatment
    Arm/Group DescriptionSubjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery. LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is 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.Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery. LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is 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.
    Measure Participants17130
    Mean (Standard Deviation) [Change in SPEED Score]
    -3.4
    (5.7)
    1.2
    (5.4)
    3. Other Pre-specified Outcome
    TitleMean Change in Ocular Surface Disease Index (OSDI) Questionnaire Score From Baseline at 3 Months
    DescriptionDry eye symptoms assessed using the OSDI questionnaire are sensitivity to light, grittiness, pain or soreness, blurred vision and poor vision. The assessment considers the frequency that problems with the eyes limit performance in reading, driving at night, working with a computer or bank machine, and watching television. Also, the frequency that eyes feel uncomfortable is assessed in windy conditions, areas with low humidity, and air-conditioned areas. The frequency scale is: 0 (none of the time), 1 (some of the time), 2 (half of the time), 3 (most of the time) and 4 (all of the time). The subject can answer not applicable (N/A) if the subject did not experience the situation or condition in the past week. Total OSDI score is calculated as the sum of frequency scores for all symptoms multiplied by 25 and divided by the number of questions answered with a range from 0 to 100. A lower OSDI score represents less disability from dry eye symptoms.
    Time FrameBaseline and 3 Months post-surgery

    Outcome Measure Data

    Analysis Population Description
    Intent to Treat (ITT) Population of all randomized subjects.
    Arm/Group TitleLipiFlow Pre-treatmentUntreated ControlLipiFlow Post-treatment
    Arm/Group DescriptionSubjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery. LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is 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.Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery. LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is 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.
    Measure Participants17130
    Mean (Standard Deviation) [Change in Total OSDI Score]
    -8.7
    (22.3)
    2.0
    (17.2)
    4. Other Pre-specified Outcome
    TitleMean Change in NEI-VFQ Questionnaire Score From Baseline at 3 Months
    DescriptionThe National Eye Institute Visual Function Questionnaire (NEI-VFQ) evaluates frequency or severity of a symptoms and the effect on activities of daily living. The questionnaire has an overall score and 12 subscale scores for general health, general vision, ocular pain, difficulty with near vision activities, difficulty with distance vision activities, social functioning limitations due to vision, mental functioning limitations due to vision, role limitations due to vision, dependency on others due to vision, driving difficulties, color vision and peripheral vision. The NEI-VFQ scores range from 0 to 100 with lower scores indicating more symptoms or difficulty with activities of daily living. The questionnaire is scored by recoding responses to set values on a 0 to 100 scale such that the lowest value is set to 0 and the highest value is set to 100. The overall score is the average of vision subscale scores, excluding general health question.
    Time FrameBaseline and 3 Months post-surgery

    Outcome Measure Data

    Analysis Population Description
    Intent to Treat (ITT) Population of all randomized subjects.
    Arm/Group TitleLipiFlow Pre-treatmentUntreated ControlLipiFlow Post-treatment
    Arm/Group DescriptionSubjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery. LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is 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.Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery. LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is 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.
    Measure Participants17130
    Mean (Standard Deviation) [Change in NEI-VFQ-25 Composite Score]
    11.6
    (14.1)
    7.3
    (10.8)
    5. Other Pre-specified Outcome
    TitleMean Change in Number of MGYLS (Meibomian Glands Yielding Liquid Secretion)
    DescriptionMeibomian gland assessment was performed to evaluate the function of the meibomian glands based on the secretion characteristics from the gland orifices along the lower eyelid at the visits. Under a slit-lamp biomicrosope, the gland orifices were evaluated using a handheld instrument, Meibomian Gland Evaluator, to apply gentle pressure along the eyelid margin. This instrument provided a standardized method of applying the same amount of pressure at each visit and for each eye to ensure measurement consistency. The number of meibomian glands yielding liquid secretion (MGYLS) (i.e., cloudy or clear liquid with a grade of 2 or 3) was counted out of the 15 glands assessed with a range of 0 to 15. A higher total meibomian gland score or higher number of MGYLS reflects less meibomian gland dysfunction.
    Time FrameBaseline and 3 Months post-surgery

    Outcome Measure Data

    Analysis Population Description
    Intent to Treat (ITT) Population of all randomized subjects.
    Arm/Group TitleLipiFlow Pre-treatmentUntreated ControlLipiFlow Post-treatment
    Arm/Group DescriptionSubjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery. LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is 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.Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery. LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is 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.
    Measure Participants17130
    Measure Eyes34260
    Mean (Standard Deviation) [Change in Number of MGYLS]
    5.6
    (4.8)
    1.0
    (3.1)
    6. Other Pre-specified Outcome
    TitleMean Change in Tear Break-up Time (TBUT)
    DescriptionThe Investigator or designee measures tear break-up time (TBUT) under a slit-lamp biomicroscope following instillation of fluorescein dye in the eye using the Dry Eye Test (DET) method. Tear film break-up is defined as the first observed break-up of the tear film following the third blink. Using a stopwatch to record the time, start the stopwatch as soon as the subject opens his/her eyes after the third blink and stop the stopwatch when the first break-up of the tear film is observed. Any values recorded as greater than 20 seconds were converted to 20 seconds in the analysis. Three separate measurements were taken for each eye and were averaged for analysis. A higher tear break-up time indicates better tear film stability.
    Time FrameBaseline and 3 Months post-surgery

    Outcome Measure Data

    Analysis Population Description
    Intent to Treat (ITT) Population of all randomized subjects.
    Arm/Group TitleLipiFlow Pre-treatmentUntreated ControlLipiFlow Post-treatment
    Arm/Group DescriptionSubjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery. LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is 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.Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery. LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is 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.
    Measure Participants17130
    Measure Eyes34260
    Mean (Standard Deviation) [Change in TBUT (in seconds)]
    1.4
    (5.2)
    -0.6
    (3.0)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group TitleLipiFlow Pre-treatmentUntreated ControlLipiFlow Post-treatment
    Arm/Group DescriptionSubjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery. LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is 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.Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery. LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is 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.
    All Cause Mortality
    LipiFlow Pre-treatmentUntreated ControlLipiFlow Post-treatment
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/18 (0%) 0/16 (0%) 0/13 (0%)
    Serious Adverse Events
    LipiFlow Pre-treatmentUntreated ControlLipiFlow Post-treatment
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/18 (0%) 0/16 (0%) 0/13 (0%)
    Other (Not Including Serious) Adverse Events
    LipiFlow Pre-treatmentUntreated ControlLipiFlow Post-treatment
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/18 (0%) 0/16 (0%) 0/13 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Within 18 months of Sponsor's receipt of data from all sites, Investigators may publish or present the Investigator's individual results. Investigator must submit materials to Sponsor for review and comment at least 30 days prior to presentation or submission for publication. Investigator will consider all reasonable comments from Sponsor. Upon Sponsor's written request, Investigator agrees to delete any Proprietary Information other than Investigator's individual Study results.

    Results Point of Contact

    Name/TitleManager of Clinical and Medical Affairs
    OrganizationTearScience, Inc.
    Phone919-459-4842
    EmailLJi4@its.jnj.com
    Responsible Party:
    TearScience, Inc.
    ClinicalTrials.gov Identifier:
    NCT01808560
    Other Study ID Numbers:
    • LF005
    First Posted:
    Mar 11, 2013
    Last Update Posted:
    Sep 4, 2018
    Last Verified:
    Aug 1, 2018