Evaluation of Electronic LogMar Visual Acuity and Contrast Sensitivity in a Population of Contact Lens Wearers

• ClinicalTrials.gov Identifier: NCT03222037
• Recruitment Status: Completed
• First Posted: July 19, 2017
• Results First Posted: August 24, 2018
• Last Update Posted: September 10, 2019
• Sponsor: Johnson & Johnson Vision Care, Inc.
• Information provided by (Responsible Party): Johnson & Johnson Vision Care, Inc.

Study Description

Brief Summary:

This is a bilateral, non-dispensing, randomized, cross-over, single-masked study. There are a total of 3 visits where all study endpoints will be measured in all subjects at baseline with habitual lenses and under the two testing treatments sequentially in separate visits based on the randomization scheme

Condition or disease	Intervention/treatment	Phase
Visual Acuity	Device: senofilcon A; Device: Control	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Evaluation of Electronic LogMar Visual Acuity and Contrast Sensitivity in a Population of Contact Lens Wearers
• Actual Study Start Date: June 27, 2017
• Actual Primary Completion Date: August 4, 2017
• Actual Study Completion Date: August 4, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: TEST/SCR; Subjects who are current soft contact lens wearers between the ages of 18 and 35 will be randomized to the two different treatments (TEST/SCR) sequentially	Device: senofilcon A; Acuvue Oasys 1-Day; Device: Control; Trial Frame with best spherocylindrical refraction (SCR)
Experimental: SCR/TEST; Subjects who are current soft contact lens wearers between the ages of 18 and 35 will be randomized to the two different treatments (SCR/TEST) sequentially	Device: senofilcon A; Acuvue Oasys 1-Day; Device: Control; Trial Frame with best spherocylindrical refraction (SCR)

Outcome Measures

Primary Outcome Measures :

1. Visual Acuity (logMAR) [ Time Frame: 15 Minutes post Treatment Administration ]
   Visual Acuity was collected electronically under two conditions (high luminance low contrast and low luminance high contrast) in both eyes 15- minutes post study article administration. The average visual acuity for each lens type and condition was reported.

Secondary Outcome Measures :

1. Area Under Contrast Sensitivity Function Curve [ Time Frame: 15 minutes post treatment administration ]
   Contrast sensitivity was assessed in both eyes at 1.5, 3.0, 6.0, 12.5 and 18.0 cycles per degrees (cpd) using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patients responses using the remote (Android Tablet). After a testing session had been completed the software calculated the Area under the log contrast sensitivity function from 1.5 cpd to 18 cpd.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol
3. Between 18 and 35 (inclusive) years of age at the time of screening
4. The subject must be habitual contact lens wearers (defined as minimum 6 hours per day, 5 days a week over the last month)

5. The subject must meet all of the following three criteria:

   1. The eyes' spherical equivalent distance refraction must be in the range of -1.00 to -9.00 D (inclusive)
   2. The eyes' refractive cylinder must be less than or equal to -0.75 DC
   3. Each eye must have best corrected visual acuity of 20/25 or better.
6. The subject must have normal eyes (i.e., no ocular medications or infections of any type)

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

1. Currently pregnant or lactating
2. Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study
3. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear or may impact the functioning of the tear film (e.g., Isotretinoin)
4. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion
5. Any current use of ocular medication
6. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
7. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Efron scale
8. 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 would contraindicate contact lens wear
9. Any known hypersensitivity or allergic reaction to contact lens care products.
10. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment
11. Employee of clinical site (e.g., Investigator, Coordinator, Technician)
12. Current wearers of Acuvue Oasys 1-Day brand contact lenses

Contacts and Locations

Locations

United States, Florida

VRC East

Jacksonville, Florida, United States, 32256

Sponsors and Collaborators

Johnson & Johnson Vision Care, Inc.

  Study Documents (Full-Text)

Documents provided by Johnson & Johnson Vision Care, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] July 11, 2017

More Information

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT03222037
• Other Study ID Numbers: CR-5968
• First Posted: July 19, 2017
• Results First Posted: August 24, 2018
• Last Update Posted: September 10, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Hypersensitivity; Immune System Diseases