Status:
COMPLETED
Contact Lens Comfort Relative to Meibomian Gland Status
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Meibomian Gland Dysfunction
Eligibility:
All Genders
18-39 years
Phase:
NA
Brief Summary
This trial aims to establish a correlation between patient reported comfort while using soft contact lenses and meibomian gland dysfunction (MGD).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01819194
Start Date
March 1 2013
End Date
August 1 2013
Last Update
June 19 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fullerton, California, United States, 92831