Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye

• Sponsor: TearScience, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00832130
• Collaborator: (none)
• Enrollment: 139
• Locations: 11
• Arms: 2
• Duration (Months): 5.9
• Patients Per Site: 12.6
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the clinical utility, safety and effectiveness of the Manual Mini System compared to standardized warm compress therapy for application of controlled, localized heat 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, and chalazia.

Condition or Disease	Intervention/Treatment	Phase
Chalazion; Dry Eye Syndromes	Device: Manual Mini System; Device: iHeat Portable Warm Compress Therapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 139 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Clinical Trial for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Manual Mini System Treatment with experimental Manual Mini System	Device: Manual Mini System; In-office device treatment for meibomian gland dysfunction by a physician
Active Comparator: Warm Compress Therapy Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase	Device: Manual Mini System; In-office device treatment for meibomian gland dysfunction by a physician; Device: iHeat Portable Warm Compress Therapy; At-home daily warm compress therapy

Outcome Measures

Primary Outcome Measures

1. Meibomian Gland Assessment (Total Meibomian Gland Secretion Score) [Baseline, 2 Weeks and 4 Weeks]

   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.

2. Incidence of Device-related Adverse Events [Baseline through 4 Weeks]

   Number of eyes for which a device-related AE occurred

3. Tear Break-up Time [Baseline, 2 Weeks and 4 Weeks]

   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.

Secondary Outcome Measures

1. Dry Eye Symptoms (Total SPEED Score) [Baseline, 2 Weeks and 4 Weeks]

   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.

2. Ocular Surface Staining (Corneal Staining Sum Score) [Baseline through 4 Weeks]

   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.

3. Intraocular Pressure [Baseline through 4 Weeks]

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

4. (LogMAR) Best Spectacle Corrected Visual Acuity [Baseline, 2 Weeks and 4 Weeks]

   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.

5. Discomfort Evaluation (Discomfort/Pain Score) [Treatment and 1 Day]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• At least 18 years of age.

• Meibomian gland obstruction

• Dry eye symptoms

• Willingness to comply with study procedures and return for all visits

Exclusion Criteria:

• Ocular surgery, injury, or herpes infection within past 3 months

• Active ocular infection

• Active ocular inflammation or recurrent inflammation within past 3 months

• Moderate to severe allergic conjunctivitis

• Severe eyelid inflammation

• Eyelid abnormalities that affect lid function

• Ocular surface abnormalities that may compromise corneal integrity

• Macular disease

• Systemic disease condition or medication that causes dry eye

• Use of other treatments for meibomian gland dysfunction or dry eye

• Pregnant or nursing women

• Participation in another ophthalmic clinical trial within past 30 days

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Fayetteville	Arkansas	United States
2		Morrow	Georgia	United States
3		Highland Park	Illinois	United States
4		Edgewood	Kentucky	United States
5		Lexington	Kentucky	United States
6		Winchester	Massachusetts	United States
7		Jackson	Michigan	United States
8		Bloomington	Minnesota	United States
9		Stillwater	Minnesota	United States
10		Charlotte	North Carolina	United States
11		Lancaster	Pennsylvania	United States

Sponsors and Collaborators

• TearScience, Inc.

Investigators

• Study Director: Christy Stevens, OD, TearScience, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TearScience, Inc.
• ClinicalTrials.gov Identifier: NCT00832130
• Other Study ID Numbers: LF001
• First Posted: Jan 29, 2009
• Last Update Posted: Dec 12, 2011
• Last Verified: Dec 1, 2011

• Additional relevant MeSH terms: Chalazion; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Meibomian Gland Dysfunction

Study Results

Participant Flow

Recruitment Details	A total of 139 subjects (278 eyes) were enrolled at nine clinical sites between 03/04/2009 and 05/14/2009.
Pre-assignment Detail	At the 2 Week visit, Control subjects stopped the warm compress therapy and received a single Manual Mini (LipiFlow) crossover treatment.

Arm/Group Title	Manual Mini System	Warm Compress Therapy
Arm/Group Description	Treatment with experimental Manual Mini System	Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Period Title: Overall Study
STARTED	69	70
COMPLETED	69	70
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Manual Mini System	Warm Compress Therapy	Total
Arm/Group Description	Treatment with experimental Manual Mini System	Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase	Total of all reporting groups
Overall Participants	69	70	139
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	52.4 (14.6)	54.4 (16.4)	53.4 (15.5)
Sex: Female, Male (Count of Participants)
Female	44 63.8%	53 75.7%	97 69.8%
Male	25 36.2%	17 24.3%	42 30.2%

Outcome Measures

1. Primary Outcome

Title	Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)
Description	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.
Time Frame	Baseline, 2 Weeks and 4 Weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Manual Mini System	Warm Compress Therapy
Arm/Group Description	Treatment with experimental Manual Mini System	Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Measure Participants	65	68
Measure Eyes	130	136
Baseline (N=130, 136)	6.3 (3.5)	5.6 (3.9)
2 Weeks (N=130, 136)	14.3 (8.7)	6.1 (5.6)
4 Weeks (N=128, 132)	16.7 (8.7)	11.7 (7.3)

2. Primary Outcome

Title	Incidence of Device-related Adverse Events
Description	Number of eyes for which a device-related AE occurred
Time Frame	Baseline through 4 Weeks

Outcome Measure Data

Analysis Population Description

Results presented are of the Intent to Treat Population.

Arm/Group Title	Manual Mini System	Warm Compress Therapy
Arm/Group Description	Treatment with experimental Manual Mini System	Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Measure Participants	69	70
Measure Eyes	138	140
Number [Events]	4	2

3. Secondary Outcome

Title	Dry Eye Symptoms (Total SPEED Score)
Description	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.
Time Frame	Baseline, 2 Weeks and 4 Weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Manual Mini System	Warm Compress Therapy
Arm/Group Description	Treatment with experimental Manual Mini System	Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Measure Participants	65	68
Measure Eyes	130	136
Baseline (N=130, 136)	14.3 (4.8)	14.8 (4.8)
2 Weeks (N=130, 136)	8.1 (5.5)	11.2 (5.4)
4 Weeks (N=128, 132)	7.6 (5.8)	7.9 (5.6)

4. Secondary Outcome

Title	Ocular Surface Staining (Corneal Staining Sum Score)
Description	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.
Time Frame	Baseline through 4 Weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Manual Mini System	Warm Compress Therapy
Arm/Group Description	Treatment with experimental Manual Mini System	Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Measure Participants	69	70
Measure Eyes	138	140
Baseline	2.2 (2.2)	2.0 (2.0)
2 Weeks	1.9 (2.0)	2.0 (2.2)
4 Weeks	1.5 (1.7)	1.6 (1.9)

5. Secondary Outcome

Title	Intraocular Pressure
Description	Intraocular pressure (IOP) was evaluated by Goldmann applanation tonometry. Change in IOP from Baseline was assessed to confirm safety.
Time Frame	Baseline through 4 Weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Manual Mini System	Warm Compress Therapy
Arm/Group Description	Treatment with experimental Manual Mini System	Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Measure Participants	69	70
Measure Eyes	138	140
Baseline (N=138, 140)	13.3 (3.3)	14.0 (2.8)
Immediate Post-Treatment (N=138, 140)	14.3 (3.3)	15.0 (3.3)
4 Weeks (138, 136)	12.5 (2.9)	13.1 (2.5)

6. Secondary Outcome

Title	(LogMAR) Best Spectacle Corrected Visual Acuity
Description	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.
Time Frame	Baseline, 2 Weeks and 4 Weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Manual Mini System	Warm Compress Therapy
Arm/Group Description	Treatment with experimental Manual Mini System	Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Measure Participants	69	70
Measure Eyes	138	140
Baseline (N=138, 140)	0.00 (0.12)	0.01 (0.12)
2 Weeks (N=136, 136)	-0.02 (0.13)	0.02 (0.13)
4 Weeks (N=138, 136)	-0.02 (0.12)	-0.01 (0.13)

7. Secondary Outcome

Title	Discomfort Evaluation (Discomfort/Pain Score)
Description	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.
Time Frame	Treatment and 1 Day

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Manual Mini System	Warm Compress Therapy
Arm/Group Description	Treatment with experimental Manual Mini System	Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Measure Participants	69	70
Measure Eyes	138	140
During Treatment (N=138, 140)	1.4 (1.4)	0.1 (0.7)
Immediate Post-Treatment (N=138, 140)	0.2 (0.6)	0.0 (0.2)
1 Day (N=138)	0.2 (0.7)	NA (NA)

8. Primary Outcome

Title	Tear Break-up Time
Description	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.
Time Frame	Baseline, 2 Weeks and 4 Weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Manual Mini System	Warm Compress Therapy
Arm/Group Description	Treatment with experimental Manual Mini System	Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Measure Participants	65	68
Measure Eyes	130	136
Baseline (N=130, 136)	5.5 (2.9)	5.4 (3.5)
2 Weeks (N=130, 136)	6.9 (5.0)	5.3 (3.5)
4 Weeks (N=128, 132)	7.4 (5.5)	6.3 (4.7)

Adverse Events

Time Frame	The presence of adverse events was evaluated at all study visits, including unscheduled visits.
Arm/Group Title	Manual Mini System		Warm Compress Therapy
Arm/Group Description	Treatment with experimental Manual Mini System		Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
All Cause Mortality
	Manual Mini System		Warm Compress Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Manual Mini System		Warm Compress Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/69 (1.4%)		1/70 (1.4%)
Musculoskeletal and connective tissue disorders
Elective Knee Surgery	1/69 (1.4%)	1	0/70 (0%)	0
Vascular disorders
Stroke	0/69 (0%)	0	1/70 (1.4%)	1
Other (Not Including Serious) Adverse Events
	Manual Mini System		Warm Compress Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/69 (0%)		0/70 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT 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.