Meibomian Gland DysfunctionNCT01819194

Contact Lens Comfort Relative to Meibomian Gland Status

A study testing senofilcon A in people with Meibomian Gland Dysfunction, run by Johnson & Johnson Vision Care, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial aims to establish a correlation between patient reported comfort while using soft contact lenses and meibomian gland dysfunction (MGD). Read more about this study

Who is it for?: Ages 18 to 39 yearsHealthy volunteers can take part
Conditions the study is for: Meibomian Gland Dysfunction
What is being tested?: senofilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteUnited States
Study dates: Mar 2013to Aug 2013
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 to 39 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

The subject must be able to read, understand, and sign the statement of informed consent and receive a fully executed copy of the form.
The subject be able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must be 18 and less than 39 years of age.
The subject must be an adapted soft contact lens wearer in both eyes (Defined as having been a full times lens wearer for at least 3 months).
Subjects must be current full time daily wearers of Acuvue Oasys lenses (defined as, at least 6 hours per day, 5 days per week).
The subject's spherical equivalent distance refraction must be in the range of 0.00 to -6.00D in each eye.

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The subject must present at visit 1 with a current copy of their spectacle prescription.
The subject must have the best corrected visual acuity of 0.18 or better in each eye as assessed by LogMAR chart.
The subject must have normal eyes (i.e., no ocular medication, or infections of any type)

Who cannot join

Wear Acuvue Oasys with Hydraclear Plus on an extended wear basis.
Wear Acuvue Oasys with Hydraclear Plus for astigmatism.
History of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva; mycobacterial infection of the eye; and/or fungal disease of the eye.
Use of concomitant ocular medications during the study period. Topical artificial tears or contact lens lubricants are allowed, but no instillation on the day of examinations.
Any systemic disease, autoimmune disease, or use of medications, which may interfere with contact lens wear.
Subjects using medications influencing tear production such as steroids, immunosuppressive agents and/or anti-cholinergics (e.g. cold and allergy medications, tricyclic antidepressants) for treatment of autoimmune connective tissue disease may not be enrolled in this study if they have not been on a stable dosing regimen for 30 days prior to the Eligibility Visit. Subjects may use birth control medications since there is inconclusive evidence relative to the influence on tear film.

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Any infectious disease (e.g. Hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV, by self report).
Subjects reporting discomfort at screening visit related to fit or care system abnormalities (both determined by the investigator), ocular conditions such as conjunctival infections, iritis.
Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
Entropion, ectropion, extrusion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosion,aphakia, or moderate or above corneal distortion by keratometry.
Any previous, or planned, ocular or intraocular surgery (radial keratotomy, LASIK, ETC.)
Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g. past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
Monovision or multi-focal contact lens correction
Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment
History of binocular vision abnormality or strabismus
History of serious mental illness
History of seizures

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Fullerton, California, 92831

Other trials in United States

About this study

This trial aims to establish a correlation between patient reported comfort while using soft contact lenses and meibomian gland dysfunction (MGD).

Conditions: Meibomian Gland Dysfunction
Being tested: senofilcon A
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.

senofilcon ADevice

Study groups in NCT01819194
Study group	Role	What they receive
senofilcon A	Experimental	Acuvvue Oasys with Hydaclear Plus with 38% water. Receives: Device: senofilcon A

What is being measured

The primary outcome is the main question the study is designed to answer.

Comfort as Measured by the Contact Lens Users Experience Questionnaire (CLUE)
CLUE is survey that is used to assess subjective comfort of the test article. The higher the score the better on a range of 0 to 120.
Measured: Post 3 days of wear
Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale
Meibomian Gland Dysfunction (MGD) as measured using the MGD 0 - 11 scale translated into grades 0 to 3 where 0 refers to absence of markers.
Measured: Post 3 days of wear

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Aug 2013

First posted27 Mar 2013 (estimated)
Study startMar 2013
Primary completionAug 2013
Study completionAug 2013

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 Meibomian Gland DysfunctionStudies 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: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01819194
Sponsor's protocol ID: CR-5282
Status last verified: May 2016
First submitted: 24 Mar 2013
Last updated: 19 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Not yet recruiting
TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
Active, not recruitingPhase 2
Autologous Serum Obtained by a Closed-Circuit Collection Device
GVHD, Meibomian Gland Dysfunction (Disorder)
Not yet recruitingObservational study
Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
Meibomian Gland Dysfunction, Dry Eye Syndromes
Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
Dry Eye, Evaporative Dry Eye Disease

All Meibomian Gland Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Contact Lens Comfort Relative to Meibomian Gland Status
ClinicalTrials.gov ID: NCT01819194
Acronym / sponsor ID: CR-5282
Conditions: Meibomian Gland Dysfunction
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 27 Mar 2013 (estimated)
Results: Posted 9 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This trial aims to establish a correlation between patient reported comfort while using soft contact lenses and meibomian gland dysfunction (MGD).

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 1

Arm	Type	Receives
senofilcon A	Experimental	Device: senofilcon AAcuvvue Oasys with Hydaclear Plus with 38% water.

Who may qualify

Ages: 18 to 39 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

The subject must be able to read, understand, and sign the statement of informed consent and receive a fully executed copy of the form.
The subject be able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must be 18 and less than 39 years of age.
The subject must be an adapted soft contact lens wearer in both eyes (Defined as having been a full times lens wearer for at least 3 months).
Subjects must be current full time daily wearers of Acuvue Oasys lenses (defined as, at least 6 hours per day, 5 days per week).

Key exclusion criteria (19 listed)

Wear Acuvue Oasys with Hydraclear Plus on an extended wear basis.
Wear Acuvue Oasys with Hydraclear Plus for astigmatism.
History of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva; mycobacterial infection of the eye; and/or fungal disease of the eye.
Use of concomitant ocular medications during the study period. Topical artificial tears or contact lens lubricants are allowed, but no instillation on the day of examinations.
Any systemic disease, autoimmune disease, or use of medications, which may interfere with contact lens wear.

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
senofilcon A	Device	senofilcon A

Primary outcome

Comfort as Measured by the Contact Lens Users Experience Questionnaire (CLUE)
Time frame: Post 3 days of wear
CLUE is survey that is used to assess subjective comfort of the test article. The higher the score the better on a range of 0 to 120.
Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale
Time frame: Post 3 days of wear
Meibomian Gland Dysfunction (MGD) as measured using the MGD 0 - 11 scale translated into grades 0 to 3 where 0 refers to absence of markers.

Results and safety

Results posted to the registry on 9 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall	62	60

Primary outcome: Comfort as Measured by the Contact Lens Users Experience Questionnaire (CLUE)

Time frame: Post 3 days of wear. Mean (Standard Deviation). Unit: units on a scale

Measure	Senofilcon A, 38% Water n = 60
Value	58.67 (18.430)

Population analysed: Subjects are those who were enrolled, randomized, and completed the study per protocol.

Primary outcome: Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale

Time frame: Post 3 days of wear. Number. Unit: eyes

Measure	Senofilcon A, 38% Water n = 60
Grade 0	0
Grade 1	88
Grade 2	32
Grade 3	0

Population analysed: Subjects analyzed are those who enrolled, randomized, and completed the study per protocol.

Adverse events

Time frame: Data was collected over the course of the study, approximately 1 week.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Senofilcon A, 38% Water	0 of 62 (0%)	0 of 62 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Meibomian Gland Dysfunction

Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Not yet recruiting
TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
Active, not recruitingPhase 2
Autologous Serum Obtained by a Closed-Circuit Collection Device
GVHD, Meibomian Gland Dysfunction (Disorder)
Not yet recruitingObservational study
Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
Meibomian Gland Dysfunction, Dry Eye Syndromes
Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
Dry Eye, Evaporative Dry Eye Disease

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing senofilcon A in people with Meibomian Gland Dysfunction, run by Johnson & Johnson Vision Care, Inc. 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 9 inclusion and 19 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 19 Jun 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?

Yes. Results are posted in the registry (first posted 9 Dec 2014). 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?

Comfort as Measured by the Contact Lens Users Experience Questionnaire (CLUE) (time frame: Post 3 days of wear). The study lists 2 primary outcomes in all. 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 NCT01819194.

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 19 Jun 2018.