Contact Lens DiscomfortNCT03652337
Meibomian Gland Dysfunction Management
A study testing BlephEx and Manual debridement in people with Contact Lens Discomfort and Meibomian Gland Dysfunction, run by University of the Incarnate Word at 1 site in United States.
Trial summary
The purpose of this study is to compare electronic debridement of the eyelid margin (BlephEx) to manual debridement of the eyelid margin as treatment options for patients intolerant to contact lens wear consequent to Meibomian gland dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Discomfort, Meibomian Gland Dysfunction
- What is being tested?
- BlephEx and Manual debridement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2018to 10 Apr 2019
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Habitual contact lens wearers whose contact lens wear time has reduced due to MGD will be preferentially considered for this study. Subjects who currently cannot wear contact lenses due to MGD may be considered on a case-by-case basis.
Who cannot join
- Subjects who are currently using any prescription ophthalmic medications (such as antibiotics, steroids and immunomodulatory drugs) will be excluded from participation.
- Subjects who have active ocular infections will be excluded from participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rosenberg School of Optometry
San Antonio, Texas, 78229
About this study
Official title: Meibomian Gland Dysfunction Management to Relieve Contact Lens Discomfort
The purpose of this study is to compare electronic debridement of the eyelid margin (BlephEx) to manual debridement of the eyelid margin as treatment options for patients intolerant to contact lens wear consequent to Meibomian gland dysfunction.
- Being tested
- BlephEx, Manual debridement
- Medical subject headings
- Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlephExDevice
Electronic lid margin debridement
Manual debridementDevice
Manual lid margin debridement
| Study group | Role | What they receive |
|---|---|---|
| BlephEx | Experimental | The subjects who are enrolled in this arm will undergo electronic lid margin debridement using the BlephEx instrument. Receives: Device: BlephEx |
| Manual debridement | Experimental | The subjects who are enrolled in this arm will undergo manual lid margin debridement using a stainless steel ophthalmic golf spud. Receives: Device: Manual debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic relief
Betterment of symptoms (improvement in contact lens discomfort) will be measured using two different surveys - Ocular Surface Disease Index (OSID) and Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8). The OSDI scores can range from 0 to 100. The CLDEQ-8 scores can range from 0 to 37. In both the questionnaires, a lowering of the score during follow-up visits represents a betterment of symptoms suffered by the patient. The numerical change in the scores on these two questionnaires will be documented as the change in symptom profile of the patient (betterment / worsening / stability).
Measured: 60 days
Secondary outcomes (4)
Meibography
Meibomian gland imaging will be performed to document any changes in the Meibomian gland during the study period.
Measured: 60 days
Lissamine green staining grade of the lid margin
The lid margin will be stained with Lissamine green dye. For the purpose of this study, Lissamine green staining of the eyelid margins will be graded from 0 to 4. (Zero representing "normal" or "no" staining; Four representing the highest degree of staining). During the course of the study, a decrease in lid margin staining will indicate a betterment of the health of the eyelid margin.
Measured: 60 days
Inflammatory activity
The presence or absence of Matrix Metalloproteinase-9 (MMP-9) in the tear fluid will be documented during the study visits. Presence of MMP-9 in the tear fluid indicates the presence of inflammatory activity in the tear fluid.
Measured: 60 days
Tear break-up time
Improvement in non-invasive tear break-up time measurement will be an objective outcome of the study.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start10 May 2018
- Primary completion1 Dec 2018 (estimated)
- Study completion10 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contact Lens DiscomfortStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Incarnate Word
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Optometry
- Responsible party
- Sponsor
- Investigators
- Srihari Narayanan, OD, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652337
- Sponsor's protocol ID
- 18-04-003
- Status last verified
- Sep 2018
- First submitted
- 19 Jun 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share IPD.
Publications
Korb DR, Blackie CA. Debridement-scaling: a new procedure that increases Meibomian gland function and reduces dry eye symptoms. Cornea. 2013 Dec;32(12):1554-7. doi: 10.1097/ICO.0b013e3182a73843.
PubMed 24145633
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meibomian Gland Dysfunction Management to Relieve Contact Lens Discomfort
- ClinicalTrials.gov ID
- NCT03652337
- Acronym / sponsor ID
- 18-04-003
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of the Incarnate WordUniversity, hospital or other
- Collaborators
- American Academy of Optometry
- Study start
- 10 May 2018 (actual)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 10 Apr 2019 (estimated)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare electronic debridement of the eyelid margin (BlephEx) to manual debridement of the eyelid margin as treatment options for patients intolerant to contact lens wear consequent to Meibomian gland dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BlephEx | Experimental | Device: BlephExThe subjects who are enrolled in this arm will undergo electronic lid margin debridement using the BlephEx instrument. |
| Manual debridement | Experimental | Device: Manual debridementThe subjects who are enrolled in this arm will undergo manual lid margin debridement using a stainless steel ophthalmic golf spud. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Habitual contact lens wearers whose contact lens wear time has reduced due to MGD will be preferentially considered for this study. Subjects who currently cannot wear contact lenses due to MGD may be considered on a case-by-case basis.
Key exclusion criteria (2 listed)
- Subjects who are currently using any prescription ophthalmic medications (such as antibiotics, steroids and immunomodulatory drugs) will be excluded from participation.
- Subjects who have active ocular infections will be excluded from participation.
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 |
|---|---|---|
| BlephExElectronic lid margin debridement | Device | BlephEx |
| Manual debridementManual lid margin debridement | Device | Manual debridement |
Primary outcome
Symptomatic relief
Time frame: 60 days
Betterment of symptoms (improvement in contact lens discomfort) will be measured using two different surveys - Ocular Surface Disease Index (OSID) and Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8). The OSDI scores can range from 0 to 100. The CLDEQ-8 scores can range from 0 to 37. In both the questionnaires, a lowering of the score during follow-up visits represents a betterment of symptoms suffered by the patient. The numerical change in the scores on these two questionnaires will be documented as the change in symptom profile of the patient (betterment / worsening / stability).
4 secondary outcomes
Meibography
Time frame: 60 days
Lissamine green staining grade of the lid margin
Time frame: 60 days
Inflammatory activity
Time frame: 60 days
Tear break-up time
Time frame: 60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Results publication: PubMed 24145633Korb DR, Blackie CA. Debridement-scaling: a new procedure that increases Meibomian gland function and reduces dry eye symptoms. Cornea. 2013 Dec;32(12):1554-7. doi: 10.1097/ICO.0b013e3182a73843.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
Related trials for Contact Lens Discomfort
Not yet recruitingPhase 4
Contact Lens-Wearing Dry Eye Subjects Who Are Treated With Acoltremon 0.003%
Dry Eye, Contact Lens Discomfort
Recruiting
Treating Contact Lens Discomfort With Varenicline Solution Nasal Spray 0.03mg
Dry Eye
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.
Srihari Narayanan, OD, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BlephEx and Manual debridement in people with Contact Lens Discomfort and Meibomian Gland Dysfunction, run by University of the Incarnate Word at 1 site 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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Symptomatic relief (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03652337, which also lists 1 linked publication.
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 5 Sep 2018.