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

Phase 4

Completed

• Conditions: Visual Acuity
• Interventions: Device: senofilcon A; Device: Control

• Registration Number: NCT03222037
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-27
• Study First Submitted: 2017-07-17
• Study First Submitted QC: 2017-07-17
• Study First Posted: 2017-07-19
• Primary Completion: 2017-08-04
• Study Completion: 2017-08-04
• Results First Submitted: 2018-07-27
• Results First Submitted QC: 2018-07-27
• Results First Posted: 2018-08-24
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TEST/SCR	senofilcon A	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
SCR/TEST	Control	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
SCR/TEST	senofilcon A	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
TEST/SCR	Control	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

Primary Outcome Measures

Name	Time	Method
Visual Acuity (logMAR)	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

Name	Time	Method
Area Under Contrast Sensitivity Function Curve	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.

Trial Locations

Locations (1)

VRC East; 🇺🇸 Jacksonville, Florida, United States