Clinical Evaluation of Investigational Contact Lenses

Johnson & Johnson (J&J)

Status: Completed

Conditions: Visual Acuity

Treatments: Device: Etafilcon A Design 1 (Test 1); Device: Etafilcon A (Control); Device: Etafilcon A Design 2 (Test 2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02801396

CR-5759

Details and patient eligibility

About

Single-visit, unmasked, non-dispensing study where subjects will wear three different lenses bilaterally in one visit, each lens being worn for approximately 30-60 minutes. Subjects will complete a questionnaire for each study lens.

Enrollment: 116 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subjects must be at least 18 years of age and no more than 55 years of age (inclusive).
2. The subject's vertex corrected best spherical distance refraction must be in the range of -1.00 to -6.00 Diopters (D) in each eye.
3. The subject's vertex corrected cylindrical component of distance refraction must be less than or equal to -1.50 Diopters of Cylinder (DC) in each eye.
4. Subjects must have best corrected visual acuity of 20/25 (Snellen or equivalent) or better in each eye.
5. Subjects must self-report as being Asian race.
6. Subjects must self-report as having brown or black eyes.
7. Subjects must be habitual lens wearer (clear or limbal ring cosmetic) . Habitual is defined as at least one (1) month of Contact Lens wear where the lenses were worn for a minimum of six (6) hours per day and a minimum of three (3) days per week.
8. Subjects between 18 to 39 years old must be habitual limbal ring cosmetic lens wearers or must have tried limbal ring cosmetic lens within the past two years.
9. Subjects must be cosmetic contact lens concept acceptors as determined by screening questionnaire.
10. Subjects must possess a functional / usable pair of spectacles and bring them to the visit (only if applicable - to the investigator's discretion).
11. Subjects must read, understand, and sign the Statement of Informed Consent.
12. Subjects must appear able and willing to adhere to the instructions set forth in the clinical protocol.
13. Subjects must be willing to have their eyes video recorded and photographed.

Exclusion criteria

1. Working for any advertising agency, any company involved in public relations or marketing, market research; or any company that makes or sells contact lenses or glasses.
2. Participated in any paid market research within the past 3 months.
3. Pregnant or breast feeding a baby.
4. Subjects with diabetes.
5. Any ocular or systemic allergies or disease which might interfere with contact lens wear.
6. Any systemic disease, or autoimmune disease, which might interfere with contact lens wear, at investigator's discretion.
7. Using medications during and immediately preceding the study period that may interfere with current contact lens wear as determined by the investigators
8. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
9. Any grade 3 or greater Biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA classification scale.
10. Any active ocular abnormalities/conditions that might interfere with contact lens wear (this includes, but not limited to, chalazia, recurrent styles, pterygium, infection etc.).
11. Any corneal distortion, scar, or opacity affecting vision as noted by subjects or investigators during examination.
12. History of any corneal surgery (e.g. radial keratotomy (RK), photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK)); confirmed with topography if necessary at the investigator's discretion.
13. Habitual wearers of rigid gas permeable or orthokeratology lens within the past 3 months.
14. Current habitual contact lens modality for extended wear or conventional wear (contact lenses with a replacement schedule of 3 months to >1 year).
15. Participation in any pharmaceutical, medical device, or contact lens related clinical research trial within 14 days prior to study enrollment. This excludes studies that do not require product treatment/intervention.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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116 participants in 6 patient groups

Group Sequence A, B, C

Active Comparator group

Description:

Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses.

Treatment:

Device: Etafilcon A (Control)

Device: Etafilcon A Design 1 (Test 1)

Device: Etafilcon A Design 2 (Test 2)

Group Sequence B, C, A

Active Comparator group

Description:

Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses.

Treatment:

Device: Etafilcon A (Control)

Device: Etafilcon A Design 1 (Test 1)

Device: Etafilcon A Design 2 (Test 2)

Group Sequence C, A, B

Active Comparator group

Description:

Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses.

Treatment:

Device: Etafilcon A (Control)

Device: Etafilcon A Design 1 (Test 1)

Device: Etafilcon A Design 2 (Test 2)

Group Sequence C, B, A

Active Comparator group

Description:

Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses.

Treatment:

Device: Etafilcon A (Control)

Device: Etafilcon A Design 1 (Test 1)

Device: Etafilcon A Design 2 (Test 2)

Group Sequence A, C, B

Active Comparator group

Description:

Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses.

Treatment:

Device: Etafilcon A (Control)

Device: Etafilcon A Design 1 (Test 1)

Device: Etafilcon A Design 2 (Test 2)

Group Sequence B, A, C

Active Comparator group

Description:

Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses.

Treatment:

Device: Etafilcon A (Control)

Device: Etafilcon A Design 1 (Test 1)

Device: Etafilcon A Design 2 (Test 2)