Fullerton, California, 92831, United States
NCT Number: NCT01819194
Contact Lens Comfort Relative to Meibomian Gland Status
This trial aims to establish a correlation between patient reported comfort while using soft contact lenses and meibomian gland dysfunction (MGD).
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Notify MeKey information
Age range
18 year–39 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
- 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)
Exclusion criteria
- 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.
- 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
Treatment and study plan
Senofilcon A
DevicePrimary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Johnson & Johnson Vision Care, Inc.
Industry
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Mar 27, 2013
- Registry last updated
- Jun 19, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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