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Treatment of Meibomian Gland Dysfunction Prior to Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01808560
Recruitment Status : Completed
First Posted : March 11, 2013
Results First Posted : May 14, 2018
Last Update Posted : September 4, 2018
Sponsor:
Information provided by (Responsible Party):
TearScience, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Blepharitis
Dry Eye Syndrome
Interventions Device: LipiFlow Pre-Treatment
Device: LipiFlow Post-treatment
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LipiFlow Pre-treatment Untreated Control LipiFlow Post-treatment
Hide Arm/Group Description

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.

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
Started 18 16 0
Completed 18 16 0
Not Completed 0 0 0
Period Title: 1-Month After Cataract Surgery
Started 16 [1] 13 [2] 0
Completed 16 13 0
Not Completed 0 0 0
[1]
ITT: 2 subjects withdrew b/c they were unable to complete cataract surgery scheduled for both eyes
[2]
ITT: 3 subjects withdrew b/c they were unable to complete cataract surgery scheduled for both eyes
Period Title: 3-Month After Cataract Surgery
Started 17 13 0
Completed 17 13 0
Not Completed 0 0 0
Period Title: Crossover Treatment
Started 0 0 13 [1]
Completed 0 0 13
Not Completed 0 0 0
[1]
Post-Treatment Group Received Crossover LipiFlow treatment 3 Months after cataract surgery
Period Title: 4-Month After Cataract Surgery
Started 0 0 13
Completed 0 0 13
Not Completed 0 0 0
Arm/Group Title LipiFlow Pre-treatment Untreated Control LipiFlow Post-treatment Total
Hide Arm/Group Description

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.

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 Number of Baseline Participants 18 16 0 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 16 participants 0 participants 34 participants
71.9  (5.7) 68.6  (6.4) 70.4  (6.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 0 participants 34 participants
Female
13
  72.2%
12
  75.0%
25
  73.5%
Male
5
  27.8%
4
  25.0%
9
  26.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 0 participants 34 participants
Hispanic or Latino
1
   5.6%
0
   0.0%
1
   2.9%
Not Hispanic or Latino
17
  94.4%
16
 100.0%
33
  97.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 0 participants 34 participants
American Indian or Alaska Native
0
   0.0%
1
   6.3%
1
   2.9%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   5.6%
0
   0.0%
1
   2.9%
White
17
  94.4%
15
  93.8%
32
  94.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Mean Change in Total Meibomian Gland Score
Hide Description

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.

Time Frame Baseline and 3 Months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population of all randomized subjects.
Arm/Group Title LipiFlow Pre-treatment Untreated Control LipiFlow Post-treatment
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 17 13 0
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
34 26 0
Mean (Standard Deviation)
Unit of Measure: Change in Meibomian Gland Score
12.8  (9.9) 1.9  (6.1)
2.Secondary Outcome
Title Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months
Hide Description 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.
Time Frame Baseline and 3 Months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population of all randomized subjects.
Arm/Group Title LipiFlow Pre-treatment Untreated Control LipiFlow Post-treatment
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 17 13 0
Mean (Standard Deviation)
Unit of Measure: Change in SPEED Score
-3.4  (5.7) 1.2  (5.4)
3.Other Pre-specified Outcome
Title Mean Change in Ocular Surface Disease Index (OSDI) Questionnaire Score From Baseline at 3 Months
Hide Description 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.
Time Frame Baseline and 3 Months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population of all randomized subjects.
Arm/Group Title LipiFlow Pre-treatment Untreated Control LipiFlow Post-treatment
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 17 13 0
Mean (Standard Deviation)
Unit of Measure: Change in Total OSDI Score
-8.7  (22.3) 2.0  (17.2)
4.Other Pre-specified Outcome
Title Mean Change in NEI-VFQ Questionnaire Score From Baseline at 3 Months
Hide Description

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.

Time Frame Baseline and 3 Months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population of all randomized subjects.
Arm/Group Title LipiFlow Pre-treatment Untreated Control LipiFlow Post-treatment
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 17 13 0
Mean (Standard Deviation)
Unit of Measure: Change in NEI-VFQ-25 Composite Score
11.6  (14.1) 7.3  (10.8)
5.Other Pre-specified Outcome
Title Mean Change in Number of MGYLS (Meibomian Glands Yielding Liquid Secretion)
Hide Description

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.

Time Frame Baseline and 3 Months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population of all randomized subjects.
Arm/Group Title LipiFlow Pre-treatment Untreated Control LipiFlow Post-treatment
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 17 13 0
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
34 26 0
Mean (Standard Deviation)
Unit of Measure: Change in Number of MGYLS
5.6  (4.8) 1.0  (3.1)
6.Other Pre-specified Outcome
Title Mean Change in Tear Break-up Time (TBUT)
Hide Description

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.

Time Frame Baseline and 3 Months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population of all randomized subjects.
Arm/Group Title LipiFlow Pre-treatment Untreated Control LipiFlow Post-treatment
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 17 13 0
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
34 26 0
Mean (Standard Deviation)
Unit of Measure: Change in TBUT (in seconds)
1.4  (5.2) -0.6  (3.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LipiFlow Pre-treatment Untreated Control LipiFlow Post-treatment
Hide Arm/Group Description

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.

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-treatment Untreated Control LipiFlow Post-treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%)   0/13 (0.00%) 
Hide Serious Adverse Events
LipiFlow Pre-treatment Untreated Control LipiFlow Post-treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%)   0/13 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
LipiFlow Pre-treatment Untreated Control LipiFlow Post-treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%)   0/13 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Layout table for Results Point of Contact information
Name/Title: Manager of Clinical and Medical Affairs
Organization: TearScience, Inc.
Phone: 919-459-4842
EMail: LJi4@its.jnj.com
Layout table for additonal information
Responsible Party: TearScience, Inc.
ClinicalTrials.gov Identifier: NCT01808560    
Other Study ID Numbers: LF005
First Submitted: March 7, 2013
First Posted: March 11, 2013
Results First Submitted: March 9, 2018
Results First Posted: May 14, 2018
Last Update Posted: September 4, 2018