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Contact Lens Comfort Relative to Meibomian Gland Status

Primary Purpose

Meibomian Gland Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
senofilcon A
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Meibomian Gland Dysfunction

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

senofilcon A

Arm Description

Acuvvue Oasys with Hydaclear Plus with 38% water.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 24, 2013
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01819194
Brief Title
Contact Lens Comfort Relative to Meibomian Gland Status
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
senofilcon A
Arm Type
Experimental
Arm Description
Acuvvue Oasys with Hydaclear Plus with 38% water.
Intervention Type
Device
Intervention Name(s)
senofilcon A
Primary Outcome Measure Information:
Title
Comfort as Measured by the Contact Lens Users Experience Questionnaire (CLUE)
Description
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.
Time Frame
Post 3 days of wear
Title
Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale
Description
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.
Time Frame
Post 3 days of wear

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
City
Fullerton
State/Province
California
ZIP/Postal Code
92831
Country
United States

12. IPD Sharing Statement

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Contact Lens Comfort Relative to Meibomian Gland Status

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