ChalazionNCT00832130
Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye
A study testing Manual Mini System and iHeat Portable Warm Compress Therapy in people with Chalazion and Dry Eye Syndromes, run by TearScience, Inc. at 11 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chalazion, Dry Eye Syndromes
- What is being tested?
- Manual Mini System and iHeat Portable Warm Compress Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 11 sitesUnited States
- Study dates
- Feb 2009to Aug 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age.
- Meibomian gland obstruction
- Dry eye symptoms
- Willingness to comply with study procedures and return for all visits
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Study site
Bloomington, Minnesota
Study site
Charlotte, North Carolina
Study site
Edgewood, Kentucky
Study site
Fayetteville, Arkansas
Study site
Highland Park, Illinois
Study site
Jackson, Michigan
Study site
Lancaster, Pennsylvania
Study site
Lexington, Kentucky
Study site
Morrow, Georgia
Study site
Stillwater, Minnesota
Study site
Winchester, Massachusetts
About this study
Official title: Randomized Clinical Trial for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye
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.
- Conditions
- Chalazion, Dry Eye Syndromes
- Being tested
- Manual Mini System, iHeat Portable Warm Compress Therapy
- Medical subject headings
- Chalazion, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Mini SystemDevice
In-office device treatment for meibomian gland dysfunction by a physician
iHeat Portable Warm Compress TherapyDevice
At-home daily warm compress therapy
| Study group | Role | What they receive |
|---|---|---|
| Manual Mini System | Experimental | Treatment with experimental Manual Mini System Receives: Device: Manual Mini System |
| Warm Compress Therapy | Active comparator | Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase Receives: Device: Manual Mini System; Device: iHeat Portable Warm Compress Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)
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.
Measured: Baseline, 2 Weeks and 4 Weeks
Incidence of Device-related Adverse Events
Number of eyes for which a device-related AE occurred
Measured: Baseline through 4 Weeks
Tear Break-up Time
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.
Measured: Baseline, 2 Weeks and 4 Weeks
Secondary outcomes (5)
Dry Eye Symptoms (Total SPEED Score)
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.
Measured: Baseline, 2 Weeks and 4 Weeks
Ocular Surface Staining (Corneal Staining Sum Score)
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.
Measured: Baseline through 4 Weeks
Intraocular Pressure
Intraocular pressure (IOP) was evaluated by Goldmann applanation tonometry. Change in IOP from Baseline was assessed to confirm safety.
Measured: Baseline through 4 Weeks
(LogMAR) Best Spectacle Corrected Visual Acuity
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.
Measured: Baseline, 2 Weeks and 4 Weeks
Discomfort Evaluation (Discomfort/Pain Score)
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.
Measured: Treatment and 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ChalazionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- TearScience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christy Stevens, OD, Study director, TearScience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832130
- Sponsor's protocol ID
- LF001
- Status last verified
- Dec 2011
- First submitted
- 27 Jan 2009
- Last updated
- 12 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye
- ClinicalTrials.gov ID
- NCT00832130
- Acronym / sponsor ID
- LF001
- Conditions
- Chalazion, Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- TearScience, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 29 Jan 2009 (estimated)
- Results
- Posted 6 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Mini System | Experimental | Device: Manual Mini SystemTreatment with experimental Manual Mini System |
| Warm Compress Therapy | Active comparator | Device: Manual Mini System, Device: iHeat Portable Warm Compress TherapyControl group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age.
- Meibomian gland obstruction
- Dry eye symptoms
- Willingness to comply with study procedures and return for all visits
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Mini SystemIn-office device treatment for meibomian gland dysfunction by a physician | Device | Manual Mini System, Warm Compress Therapy |
| iHeat Portable Warm Compress TherapyAt-home daily warm compress therapy | Device | Warm Compress Therapy |
Primary outcome
Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)
Time frame: 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.
Incidence of Device-related Adverse Events
Time frame: Baseline through 4 Weeks
Number of eyes for which a device-related AE occurred
Tear Break-up Time
Time frame: 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.
5 secondary outcomes
Dry Eye Symptoms (Total SPEED Score)
Time frame: Baseline, 2 Weeks and 4 Weeks
Ocular Surface Staining (Corneal Staining Sum Score)
Time frame: Baseline through 4 Weeks
Intraocular Pressure
Time frame: Baseline through 4 Weeks
(LogMAR) Best Spectacle Corrected Visual Acuity
Time frame: Baseline, 2 Weeks and 4 Weeks
Discomfort Evaluation (Discomfort/Pain Score)
Time frame: Treatment and 1 Day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chalazion
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Is the Use of a Steam Mask an Effective Treatment for Paediatric Chalazion in Comparison to Traditional Warm Compresses?
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christy Stevens, OD study director
TearScience, Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Mini System and iHeat Portable Warm Compress Therapy in people with Chalazion and Dry Eye Syndromes, run by TearScience, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meibomian Gland Assessment (Total Meibomian Gland Secretion Score) (time frame: Baseline, 2 Weeks and 4 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2011.