Contact Lens Comfort Relative to Meibomian Gland Status

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01819194
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 12.7

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Meibomian Gland Dysfunction	Device: senofilcon A	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: senofilcon A Acuvvue Oasys with Hydaclear Plus with 38% water.	Device: senofilcon A

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Fullerton	California	United States	92831

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT01819194
• Other Study ID Numbers: CR-5282
• First Posted: Mar 27, 2013
• Last Update Posted: Jun 19, 2018
• Last Verified: May 1, 2016

• Additional relevant MeSH terms: Meibomian Gland Dysfunction

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Overall
Arm/Group Description	Subjects only wore one lens: senofilcon A, 38% water. Subjects, were enrolled and screened per inclusion/exclusion criteria.
Period Title: Overall Study
STARTED	62
COMPLETED	60
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Dispensed Subjects
Arm/Group Description	All subjects that were dispensed the study lens.
Overall Participants	64
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	24.53 (3.050)
Sex: Female, Male (Count of Participants)
Female	49 76.6%
Male	15 23.4%
Region of Enrollment (participants) [Number]
United States	64 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects are those who were enrolled, randomized, and completed the study per protocol.

Arm/Group Title	Senofilcon A, 38% Water
Arm/Group Description	Senofilcon A, 38% water
Measure Participants	60
Mean (Standard Deviation) [units on a scale]	58.67 (18.430)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects analyzed are those who enrolled, randomized, and completed the study per protocol.

Arm/Group Title	Senofilcon A, 38% Water
Arm/Group Description	Senofilcon A, 38% water
Measure Participants	60
Measure Eyes	120
Grade 0	0
Grade 1	88
Grade 2	32
Grade 3	0

Adverse Events

Time Frame	Data was collected over the course of the study, approximately 1 week.
Arm/Group Title	Senofilcon A, 38% Water
Arm/Group Description	Senofilcon A, 38% water
All Cause Mortality
	Senofilcon A, 38% Water
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Senofilcon A, 38% Water
	Affected / at Risk (%)	# Events
Total	0/62 (0%)
Other (Not Including Serious) Adverse Events
	Senofilcon A, 38% Water
	Affected / at Risk (%)	# Events
Total	0/62 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.