Evaluation of Approved and Investigational Contact Lenses

NCT ID: NCT03228212

Last Updated: 2018-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-14
• Study Completion Date: 2017-09-18

Brief Summary

This study is a randomized, 5-visit, partial subject masked, 2x3 bilateral crossover, dispensing clinical trial. During the study, each test article will be worn in a daily wear modality for at least 6 hours per day and 5 days per week for approximately 2 weeks each. The subject will wear either the Test or Control article twice and the other study article once. The primary objective of this study is to demonstrate that the Test lens works as well, if not better compared to the Control lens with respect to CLUE (Contact Lens User Experience) comfort, Slit Lamp findings, and Distance Monocular logMAR Visual Acuity. This study will also aim to show acceptable lens fit for subjects wearing the Test lens.

Conditions

Visual Acuity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TEST/CONTROL/CONTROL

Enrolled subjects will be habitual wearers of spherical contact lenses between the ages of 18 and 49 years old. Subjects will wear the Test and Control contact lenses bilaterally for approximately 2 weeks each on a daily wear basis. Subjects will be randomly assigned to one of the two lens wear sequences, (TEST/CONTROL/CONTROL)

Group Type: EXPERIMENTAL

CONTROL

Intervention Type: DEVICE

ACUVUE OASYS

TEST

Intervention Type: DEVICE

senofilcon A with new UV blocker

CONTROL/TEST/TEST

Enrolled subjects will be habitual wearers of spherical contact lenses between the ages of 18 and 49 years old. Subjects will wear the Test and Control contact lenses bilaterally for approximately 2 weeks each on a daily wear basis. Subjects will be randomly assigned to one of the two lens wear sequences, (CONTROL/TEST/TEST)

Group Type: EXPERIMENTAL

CONTROL

Intervention Type: DEVICE

ACUVUE OASYS

TEST

Intervention Type: DEVICE

senofilcon A with new UV blocker

Interventions

CONTROL

ACUVUE OASYS

Intervention Type: DEVICE

TEST

senofilcon A with new UV blocker

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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 age ≥18 and ≤49 years of age with signed informed consent. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them.

4. The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 6.00 Diopter (D).

5. The subject's refractive cylinder must be ≤ 1.00D in each eye.

6. The subject must have visual acuity best correctable to 20/25+3 or better for each eye.

7. Subjects must own a wearable pair of spectacles.

8. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of Daily Wear per day, at least 5 days per week, for a minimum of 1 month prior to the study) and willing to wear the study lenses on a similar basis.

9. Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week

10. 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 (subjects who become pregnant during the study will be discontinued).

2. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).

3. Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g., Chlor-Trimeton, and Benadryl) and ophthalmic antihistamines, oral phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), oral and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and Practolol), systemic steroids, and any prescribed or over the counter (OTC) ocular medication.

4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.

5. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), LASIK, etc.).

6. Any Grade 3 or greater slit lamp findings (e.g.., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, 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 may contraindicate contact lens wear.

7. Any known hypersensitivity or allergic reaction to Optifree®PureMoist® multi-purpose care solution or Eye-Cept® rewetting drop solution

8. Any ocular infection, allergy or clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular conditions (e.g. strabismus), which might interfere with the study.

9. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

10. Toric, extended wear, monovision or multi-focal contact lens correction.

11. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

12. Participation in clinical trials involving the Test lens within 3 months prior to study enrollment.

13. History of binocular vision abnormality or strabismus.

14. Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dr. James Weber & Associates, PA

Jacksonville, Florida, United States

Vue Optical Boutique

Jacksonville, Florida, United States

VisionCare Associates

East Lansing, Michigan, United States

Pickens Family Eye Care

Pickens, South Carolina, United States

William J. Bogus, OD

Salt Lake City, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-5960

Identifier Type: -

Identifier Source: org_study_id