Contact Lens Comfort Relative to Meibomian Gland Status

Completed · Not applicable

Conditions studied: Meibomian Gland Dysfunction

In brief

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

Key facts

Study ID

NCT01819194

Run by

Johnson & Johnson Vision Care, Inc.

People needed

64

Starts

2013-03-01

Expected to finish

2013-08-01

Last updated by the study team

2018-06-19

Who can join

Age: 18 and older, up to 39. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Fullerton, California, United States

Full record on ClinicalTrials.gov

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