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

Johnson & Johnson (J&J)

Status: Completed

Conditions: Visual Acuity

Treatments: Device: Test 8.5BC; Device: Test 9.0BC; Device: Control 8.5BC; Device: Control 9.0BC

Study type: Interventional

Funder types: Industry

Identifiers

NCT03139578

CR-5932

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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51 participants in 4 patient groups

C 8.5\C 9.0\T 8.5\T 9.0

Experimental group

Description:

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.

Treatment:

Device: Test 8.5BC

Device: Test 9.0BC

Device: Control 9.0BC

Device: Control 8.5BC

C 9.0\C 8.5\T 9.0\T 8.5

Experimental group

Description:

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.

Treatment:

Device: Test 8.5BC

Device: Test 9.0BC

Device: Control 9.0BC

Device: Control 8.5BC

T 8.5\T 9.0\C 8.5\C 9.0

Experimental group

Description:

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.

Treatment:

Device: Test 8.5BC

Device: Test 9.0BC

Device: Control 9.0BC

Device: Control 8.5BC

T 9.0\T 8.5\C 9.0\C 8.5

Experimental group

Description:

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.

Treatment:

Device: Test 8.5BC

Device: Test 9.0BC

Device: Control 9.0BC

Device: Control 8.5BC