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

Not Applicable

Completed

Conditions: Visual Acuity

Interventions: Device: Test 8.5BC
Device: Test 9.0BC
Device: Control 8.5BC
Device: Control 9.0BC

Registration Number: NCT03139578

Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 51

Inclusion Criteria

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

The subject must read and sign the Informed Consent form.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Healthy adult males or females aged 18-55 years.
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.
The subject's refractive cylinder must be ≤1.00 D in each eye.
The subject must have visual acuity best correctable to 6/9 (20/30) or better for each eye.
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).
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:

Currently pregnant or lactating
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.
Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear.
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.
Extended wear contact lens correction.
Any current use of ocular medication.
Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
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.
Any contact lens-related history or signs of a corneal inflammatory event, or any other ocular abnormality that would contraindicate contact lens wear.
Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrolment.
Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician).

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
C 8.5\C 9.0\T 8.5\T 9.0	Test 9.0BC	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.
C 8.5\C 9.0\T 8.5\T 9.0	Control 8.5BC	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.
C 8.5\C 9.0\T 8.5\T 9.0	Control 9.0BC	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.
C 8.5\C 9.0\T 8.5\T 9.0	Test 8.5BC	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.
C 9.0\C 8.5\T 9.0\T 8.5	Test 8.5BC	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.
C 9.0\C 8.5\T 9.0\T 8.5	Test 9.0BC	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.
C 9.0\C 8.5\T 9.0\T 8.5	Control 9.0BC	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.
T 8.5\T 9.0\C 8.5\C 9.0	Test 8.5BC	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.
T 8.5\T 9.0\C 8.5\C 9.0	Test 9.0BC	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.
T 8.5\T 9.0\C 8.5\C 9.0	Control 8.5BC	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.
T 9.0\T 8.5\C 9.0\C 8.5	Control 8.5BC	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.
T 8.5\T 9.0\C 8.5\C 9.0	Control 9.0BC	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.
C 9.0\C 8.5\T 9.0\T 8.5	Control 8.5BC	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.
T 9.0\T 8.5\C 9.0\C 8.5	Test 8.5BC	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.
T 9.0\T 8.5\C 9.0\C 8.5	Test 9.0BC	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.
T 9.0\T 8.5\C 9.0\C 8.5	Control 9.0BC	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.

Primary Outcome Measures

Name	Time	Method
Overall Fit Acceptance	30-45 minutes after lens settling	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.
Lens Power Requirement	30-45 minutes after lens settling	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).

Secondary Outcome Measures

Name	Time	Method
Subjective Comfort at Lens Insertion	Immediately upon 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.
Subjective Comfort After Lens Settling	30-45 minutes 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.
Subjective Vision Quality	30-45 minutes after lens settling	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.
Subjective Handling	Immediately upon lens insertion	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.
Monocular High Contrast Visual Acuity (VA)	30-45 minutes after lens settling	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.

Trial Locations

Locations (2): Aston University Optometry and Vision Science
🇬🇧
Birmingham, United Kingdom
Visioncare Research
🇬🇧
Farnham, United Kingdom
Aston University Optometry and Vision Science
🇬🇧Birmingham, United Kingdom