Meibomian Gland Dysfunction
Conditions
Brief summary
This trial aims to establish a correlation between patient reported comfort while using soft contact lenses and meibomian gland dysfunction (MGD).
Interventions
DEVICEsenofilcon A
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort as Measured by the Contact Lens Users Experience Questionnaire (CLUE) | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
A total of 64 subjects were enrolled in this study. Of the enrolled subjects 2 did not meet the eligibility criteria and 62 were dispensed a study lens. Of the dispensed subjects 60 completed the study and 2 were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Dispensed Subjects All subjects that were dispensed the study lens. | 64 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Loss of study articles | 2 |
Baseline characteristics
| Characteristic | Dispensed Subjects |
|---|---|
| Age, Continuous | 24.53 years STANDARD_DEVIATION 3.05 |
| Region of Enrollment United States | 64 participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 62 |
| serious Total, serious adverse events | 0 / 62 |
Outcome results
Primary
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.
Time frame: Post 3 days of wear
Population: Subjects are those who were enrolled, randomized, and completed the study per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A, 38% Water | Comfort as Measured by the Contact Lens Users Experience Questionnaire (CLUE) | 58.67 units on a scale | Standard Deviation 18.43 |
Primary
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.
Time frame: Post 3 days of wear
Population: Subjects analyzed are those who enrolled, randomized, and completed the study per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A, 38% Water | Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale | Grade 0 | 0 eyes |
| Senofilcon A, 38% Water | Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale | Grade 1 | 88 eyes |
| Senofilcon A, 38% Water | Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale | Grade 2 | 32 eyes |
| Senofilcon A, 38% Water | Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale | Grade 3 | 0 eyes |