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Trial Outcomes & Findings for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye (NCT NCT00832130)

NCT ID: NCT00832130

Last Updated: 2011-12-12

Results Overview

Evaluation of secretion characteristics from the gland orifices along the lower eyelid. Assessment was based on the grading scale: 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated), 0 (no secretion). The total meibomian gland secretion score was the sum of the grades for all 15 glands with a range of 0 to 45.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

139 participants

Primary outcome timeframe

Baseline, 2 Weeks and 4 Weeks

Results posted on

2011-12-12

Participant Flow

A total of 139 subjects (278 eyes) were enrolled at nine clinical sites between 03/04/2009 and 05/14/2009.

At the 2 Week visit, Control subjects stopped the warm compress therapy and received a single Manual Mini (LipiFlow) crossover treatment.

Participant milestones

Participant milestones
Measure
Manual Mini System
Treatment with experimental Manual Mini System
Warm Compress Therapy
Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Overall Study
STARTED
69
70
Overall Study
COMPLETED
69
70
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Manual Mini System
n=69 Participants
Treatment with experimental Manual Mini System
Warm Compress Therapy
n=70 Participants
Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Total
n=139 Participants
Total of all reporting groups
Age Continuous
52.4 Years
STANDARD_DEVIATION 14.6 • n=5 Participants
54.4 Years
STANDARD_DEVIATION 16.4 • n=7 Participants
53.4 Years
STANDARD_DEVIATION 15.5 • n=5 Participants
Sex: Female, Male
Female
44 Participants
n=5 Participants
53 Participants
n=7 Participants
97 Participants
n=5 Participants
Sex: Female, Male
Male
25 Participants
n=5 Participants
17 Participants
n=7 Participants
42 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 2 Weeks and 4 Weeks

Population: Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover.

Evaluation of secretion characteristics from the gland orifices along the lower eyelid. Assessment was based on the grading scale: 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated), 0 (no secretion). The total meibomian gland secretion score was the sum of the grades for all 15 glands with a range of 0 to 45.

Outcome measures

Outcome measures
Measure
Manual Mini System
n=130 Eyes
Treatment with experimental Manual Mini System
Warm Compress Therapy
n=136 Eyes
Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)
Baseline (N=130, 136)
6.3 Scores on a scale
Standard Deviation 3.5
5.6 Scores on a scale
Standard Deviation 3.9
Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)
2 Weeks (N=130, 136)
14.3 Scores on a scale
Standard Deviation 8.7
6.1 Scores on a scale
Standard Deviation 5.6
Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)
4 Weeks (N=128, 132)
16.7 Scores on a scale
Standard Deviation 8.7
11.7 Scores on a scale
Standard Deviation 7.3

PRIMARY outcome

Timeframe: Baseline through 4 Weeks

Population: Results presented are of the Intent to Treat Population.

Number of eyes for which a device-related AE occurred

Outcome measures

Outcome measures
Measure
Manual Mini System
n=138 Eyes
Treatment with experimental Manual Mini System
Warm Compress Therapy
n=140 Eyes
Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Incidence of Device-related Adverse Events
4 Events
2 Events

PRIMARY outcome

Timeframe: Baseline, 2 Weeks and 4 Weeks

Population: Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover.

Tear break-up time measured under a slit lamp biomicroscope following instillation of fluorescein dye in the eye. Time was measured in seconds with a maximum of 20. Higher tear break-up time indicates better tear film stability.

Outcome measures

Outcome measures
Measure
Manual Mini System
n=130 Eyes
Treatment with experimental Manual Mini System
Warm Compress Therapy
n=136 Eyes
Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Tear Break-up Time
Baseline (N=130, 136)
5.5 Seconds
Standard Deviation 2.9
5.4 Seconds
Standard Deviation 3.5
Tear Break-up Time
2 Weeks (N=130, 136)
6.9 Seconds
Standard Deviation 5.0
5.3 Seconds
Standard Deviation 3.5
Tear Break-up Time
4 Weeks (N=128, 132)
7.4 Seconds
Standard Deviation 5.5
6.3 Seconds
Standard Deviation 4.7

SECONDARY outcome

Timeframe: Baseline, 2 Weeks and 4 Weeks

Population: Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover.

Standard Patient Evaluation of Eye Dryness questionnaire. Assessment of subjects' frequency and severity of dry eye symptoms. The total score was calculated as the sum scores for all symptoms over a range of 0 to 28. A lower total SPEED score represents less frequent and/or less severe symptoms.

Outcome measures

Outcome measures
Measure
Manual Mini System
n=130 Eyes
Treatment with experimental Manual Mini System
Warm Compress Therapy
n=136 Eyes
Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Dry Eye Symptoms (Total SPEED Score)
Baseline (N=130, 136)
14.3 Scores on a scale
Standard Deviation 4.8
14.8 Scores on a scale
Standard Deviation 4.8
Dry Eye Symptoms (Total SPEED Score)
2 Weeks (N=130, 136)
8.1 Scores on a scale
Standard Deviation 5.5
11.2 Scores on a scale
Standard Deviation 5.4
Dry Eye Symptoms (Total SPEED Score)
4 Weeks (N=128, 132)
7.6 Scores on a scale
Standard Deviation 5.8
7.9 Scores on a scale
Standard Deviation 5.6

SECONDARY outcome

Timeframe: Baseline through 4 Weeks

Population: Results presented are of the Intent to Treat Population. 4 Weeks data for the Control group are after treatment crossover.

Corneal staining score in five corneal regions, evaluated on a scale from 0 (none), 1 (mild), 2 (moderate) to 3 (severe). The sum of the five corneal staining scores was on a scale from 0 to 15. A lower grade indicates less corneal surface desiccation.

Outcome measures

Outcome measures
Measure
Manual Mini System
n=138 Eyes
Treatment with experimental Manual Mini System
Warm Compress Therapy
n=140 Eyes
Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Ocular Surface Staining (Corneal Staining Sum Score)
Baseline
2.2 Scores on a scale
Standard Deviation 2.2
2.0 Scores on a scale
Standard Deviation 2.0
Ocular Surface Staining (Corneal Staining Sum Score)
2 Weeks
1.9 Scores on a scale
Standard Deviation 2.0
2.0 Scores on a scale
Standard Deviation 2.2
Ocular Surface Staining (Corneal Staining Sum Score)
4 Weeks
1.5 Scores on a scale
Standard Deviation 1.7
1.6 Scores on a scale
Standard Deviation 1.9

SECONDARY outcome

Timeframe: Baseline through 4 Weeks

Population: Results presented are of the Intent to Treat population. Post-Treatment results for the Control group are before crossover treatment. 4 Weeks results for the Control group are after crossover treatment.

Intraocular pressure (IOP) was evaluated by Goldmann applanation tonometry. Change in IOP from Baseline was assessed to confirm safety.

Outcome measures

Outcome measures
Measure
Manual Mini System
n=138 Eyes
Treatment with experimental Manual Mini System
Warm Compress Therapy
n=140 Eyes
Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Intraocular Pressure
Baseline (N=138, 140)
13.3 mmHg
Standard Deviation 3.3
14.0 mmHg
Standard Deviation 2.8
Intraocular Pressure
Immediate Post-Treatment (N=138, 140)
14.3 mmHg
Standard Deviation 3.3
15.0 mmHg
Standard Deviation 3.3
Intraocular Pressure
4 Weeks (138, 136)
12.5 mmHg
Standard Deviation 2.9
13.1 mmHg
Standard Deviation 2.5

SECONDARY outcome

Timeframe: Baseline, 2 Weeks and 4 Weeks

Population: Results presented are of the Intent to Treat population. 2 Weeks data for the Control group are after control treatment, but before crossover treatment. 4 Weeks data for the Control group are after crossover treatment.

Measurement of BSCVA at a distance using a logMAR chart under standard illumination. The logMAR ranged from -0.30 to 1.0. A lower logMAR value is a better visual acuity.

Outcome measures

Outcome measures
Measure
Manual Mini System
n=138 Eyes
Treatment with experimental Manual Mini System
Warm Compress Therapy
n=140 Eyes
Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
(LogMAR) Best Spectacle Corrected Visual Acuity
Baseline (N=138, 140)
0.00 LogMAR
Standard Deviation 0.12
0.01 LogMAR
Standard Deviation 0.12
(LogMAR) Best Spectacle Corrected Visual Acuity
2 Weeks (N=136, 136)
-0.02 LogMAR
Standard Deviation 0.13
0.02 LogMAR
Standard Deviation 0.13
(LogMAR) Best Spectacle Corrected Visual Acuity
4 Weeks (N=138, 136)
-0.02 LogMAR
Standard Deviation 0.12
-0.01 LogMAR
Standard Deviation 0.13

SECONDARY outcome

Timeframe: Treatment and 1 Day

Population: Results presented are of the Intent to Treat population. Only the Manual Mini group underwent a 1 day assessment.

Subject-reported numeric score reflecting low or high intensity. Scores ranged from 0 to 10, with 0 being no discomfort or pain and 10 being intolerable pain.

Outcome measures

Outcome measures
Measure
Manual Mini System
n=138 Eyes
Treatment with experimental Manual Mini System
Warm Compress Therapy
n=140 Eyes
Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Discomfort Evaluation (Discomfort/Pain Score)
During Treatment (N=138, 140)
1.4 Scores on a scale
Standard Deviation 1.4
0.1 Scores on a scale
Standard Deviation 0.7
Discomfort Evaluation (Discomfort/Pain Score)
Immediate Post-Treatment (N=138, 140)
0.2 Scores on a scale
Standard Deviation 0.6
0.0 Scores on a scale
Standard Deviation 0.2
Discomfort Evaluation (Discomfort/Pain Score)
1 Day (N=138)
0.2 Scores on a scale
Standard Deviation 0.7
NA Scores on a scale
Standard Deviation NA
The Control group was not assessed for discomfort at 1 day post-treatment. This assessment refers only to discomfort after treatment with the Manual Mini System.

Adverse Events

Manual Mini System

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Warm Compress Therapy

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Manual Mini System
n=69 participants at risk
Treatment with experimental Manual Mini System
Warm Compress Therapy
n=70 participants at risk
Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Musculoskeletal and connective tissue disorders
Elective Knee Surgery
1.4%
1/69 • Number of events 1 • The presence of adverse events was evaluated at all study visits, including unscheduled visits.
0.00%
0/70 • The presence of adverse events was evaluated at all study visits, including unscheduled visits.
Vascular disorders
Stroke
0.00%
0/69 • The presence of adverse events was evaluated at all study visits, including unscheduled visits.
1.4%
1/70 • Number of events 1 • The presence of adverse events was evaluated at all study visits, including unscheduled visits.

Other adverse events

Adverse event data not reported

Additional Information

Christy Stevens, OD

TearScience, Inc. (formerly Kolis Scientific)

Phone: 919-459-4815

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place