Contact Lens Comfort Relative to Meibomian Gland Status

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01819194
First received: March 24, 2013
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Meibomian Gland Dysfunction
Device: Senofilcon A, 38% water
Other: No contact lens wear

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Comfort as measured by the Contact Lens Users Experience Questionnaire [ Time Frame: Post 3 days of wear ] [ Designated as safety issue: No ]
  • Meibbomian Gland Dysfunction (MGD)as measured by MGD Scale [ Time Frame: Post 3 days of wear ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: March 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Senofilcon A, 38% water
Acuvvue Oasys with Hydaclear Plus
Device: Senofilcon A, 38% water Other: No contact lens wear

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The subject must be able to read, understand, and sign the statement of informed consent and receive a fully executed copy of the form.
  2. The subject be able and willing to adhere to the instructions set forth in this clinical protocol.
  3. The subject must be 18 and less than 39 years of age.
  4. 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).
  5. Subjects must be current full time daily wearers of Acuvue Oasys lenses (defined as, at least 6 hours per day, 5 days per week).
  6. The subject's spherical equivalent distance refraction must be in the range of 0.00 to -6.00D in each eye.
  7. The subject must present at visit 1 with a current copy of their spectacle prescription.
  8. The subject must have the best corrected visual acuity of 0.18 or better in each eye as assessed by LogMAR chart.
  9. The subject must have normal eyes (i.e., no ocular medication, or infections of any type)

Exclusion Criteria:

  1. Wear Acuvue Oasys with Hydraclear Plus on an extended wear basis.
  2. Wear Acuvue Oasys with Hydraclear Plus for astigmatism.
  3. 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.
  4. 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.
  5. Any systemic disease, autoimmune disease, or use of medications, which may interfere with contact lens wear.
  6. 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.
  7. Any infectious disease (e.g. Hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV, by self report).
  8. 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.
  9. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
  10. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  11. Entropion, ectropion, extrusion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosion,aphakia, or moderate or above corneal distortion by keratometry.
  12. Any previous, or planned, ocular or intraocular surgery (radial keratotomy, LASIK, ETC.)
  13. 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.
  14. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  15. Monovision or multi-focal contact lens correction
  16. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment
  17. History of binocular vision abnormality or strabismus
  18. History of serious mental illness
  19. History of seizures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01819194

Locations
United States, California
Fullerton, California, United States, 92831
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01819194     History of Changes
Other Study ID Numbers: CR-5282
Study First Received: March 24, 2013
Last Updated: December 11, 2013
Health Authority: Unites States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 30, 2014