Short-Term Clinical Comparison of Two Silicone Hydrogel Daily Disposable Contact Lenses

This will be a 2 period one-day, double-masked, randomized, repeated measures, non-dispensing, cross-over study where the main purpose of this study is to compare the performance of a new daily disposable silicone hydrogel lens with that of an existing similar lens.

Study Overview

• Status: Completed
• Conditions: Visual Acuity
• Intervention / Treatment: Device: Test 8.5BC; Device: Test 9.0BC; Device: Control 8.5BC; Device: Control 9.0BC

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom
    • Aston University Optometry and Vision Science
  • Farnham, United Kingdom
    • Visioncare research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

1. The subject must read and sign the Informed Consent form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Healthy adult males or females aged 18-55 years.
4. The subject's spherical contact lens requirement in the range +2.00 D to +4.00 D or -1.00 D to -6.00 D.
5. The subject's refractive cylinder must be ≤1.00 D in each eye.
6. The subject must have visual acuity best correctable to 6/9 (20/30) or better for each eye.
7. The subject is a current soft contact lens wearer (defined as a minimum of 6 hours of DW per day, at least 5 days per week, for a minimum of 1 month prior to the study).
8. 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.
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. Extended wear contact lens correction.
6. Any current use of ocular medication.
7. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
8. Any greater than Grade 2 slit lamp findings (e.g., oedema, corneal neovascularisation, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale or any other ocular abnormality that may contraindicate contact lens wear.
9. Any contact lens-related history or signs of a corneal inflammatory event, or any other ocular abnormality that would contraindicate contact lens wear.
10. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrolment.
11. Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: C 8.5\C 9.0\T 8.5\T 9.0; Subjects randomized to this sequence received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period.	Device: Test 8.5BC; senofilcon A contact lenses with 8.5 base curve; Device: Test 9.0BC; senofilcon A contact lenses with 9.0 base curve; Device: Control 8.5BC; narafilcon A contact lenses with 8.5 base curve; Device: Control 9.0BC; narafilcon A contact lenses with 9.0 base curve
EXPERIMENTAL: C 9.0\C 8.5\T 9.0\T 8.5; Subjects randomized to this sequence received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period.	Device: Test 8.5BC; senofilcon A contact lenses with 8.5 base curve; Device: Test 9.0BC; senofilcon A contact lenses with 9.0 base curve; Device: Control 8.5BC; narafilcon A contact lenses with 8.5 base curve; Device: Control 9.0BC; narafilcon A contact lenses with 9.0 base curve
EXPERIMENTAL: T 8.5\T 9.0\C 8.5\C 9.0; Subjects randomized to this sequence received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period.	Device: Test 8.5BC; senofilcon A contact lenses with 8.5 base curve; Device: Test 9.0BC; senofilcon A contact lenses with 9.0 base curve; Device: Control 8.5BC; narafilcon A contact lenses with 8.5 base curve; Device: Control 9.0BC; narafilcon A contact lenses with 9.0 base curve
EXPERIMENTAL: T 9.0\T 8.5\C 9.0\C 8.5; Subjects randomized to this sequence received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period.	Device: Test 8.5BC; senofilcon A contact lenses with 8.5 base curve; Device: Test 9.0BC; senofilcon A contact lenses with 9.0 base curve; Device: Control 8.5BC; narafilcon A contact lenses with 8.5 base curve; Device: Control 9.0BC; narafilcon A contact lenses with 9.0 base curve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Fit Acceptance	Overall lens fit acceptance was assessed by the investigator based on lens fitting characteristics and graded on a scale of 0 to 5, where 0=should not be worn and 5=perfect fit. The score ranges from 0 to 5, where higher scores indicate better fitting. The number of eye for each Grade was reported.	30-45 minutes after lens settling
Lens Power Requirement	The lens power requirements (aka sphere requirements) for each lens type was calculated by summing the lens power and the spherical over-refraction. Then the difference of lens power requirement between the Test and Control lenses was calculated (Test-Control).	30-45 minutes after lens settling

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Comfort at Lens Insertion	Subjective comfort on insertion was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported.	Immediately upon lens insertion
Subjective Comfort After Lens Settling	Subjective comfort on setting was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported.	30-45 minutes after lens settling
Subjective Vision Quality	Subjective vision quality was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely blurred and 10=perfect. The score ranges from 0 to 10, where higher scores indicate better vision quality. The average vision quality score for each lens was reported.	30-45 minutes after lens settling
Subjective Handling	Subjective handling was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely difficult and 10=very easy. The score ranges from 0 to 10, where higher scores indicate better handling. The average handling score for each lens was reported.	Immediately upon lens insertion
Monocular High Contrast Visual Acuity (VA)	Monocular high contrast distance VA with the study lenses was collected to the nearest letter using computer generated logMAR charts. 0.02 logMAR is equivalent to 1 letter. Negative logMAR values indicate better lens performance. The average visual acuity was reported for each lens type.	30-45 minutes after lens settling

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 28, 2017
• Primary Completion (ACTUAL): October 22, 2017
• Study Completion (ACTUAL): October 22, 2017

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (ACTUAL): May 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 11, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CR-5932

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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