Clinical Evaluation of An Approved Contact Lens

NCT ID: NCT02760810

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-12
• Study Completion Date: 2016-04-26

Brief Summary

This is an 8-visit, bilateral, dispensing clinical study to evaluate the change in tear fluid pH and tear film osmolarity in an FDA-cleared contact lens in new contact lens users over a 14-day period.

Conditions

Tear Film Characteristics

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

narafilcon A

Subjects who are new contact lens wearers (neophytes) between the ages of 18-45 will be dispensed the Test Lens and evaluated over a period of 2 weeks.

Group Type: EXPERIMENTAL

Marketed Contact Lens

Intervention Type: DEVICE

Narafilcon A

Interventions

Marketed Contact Lens

Narafilcon A

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.

2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

3. The subject must be between 18 and 45 years of age.

4. The subject must have a valid spectacle prescription with expiration date not over 1 year.

5. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.25 Diopters (D) to -6.00 D in each eye.

6. The subject's refractive cylinder must be ≤1.00 Cylindrical Diopter (DC) in each eye.

7. The subject must have best corrected visual acuity of logMAR 0.20 or better in each eye.

8. Subjects should own a wearable pair of spectacles and agree to wear them the day of the initial visit and every morning on subsequent visit days.

9. The subject must be a contact lens neophyte, defined as never having been dispensed contact lenses, or who has taken part in a non-dispensing clinical study or has been fitted with contact lenses in practice but never went on to actually wear the lenses.

10. The subject must have normal eyes (i.e. no ocular medications or infections of any type).

Exclusion Criteria

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).

2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.

3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.

4. Use of any medication with known tear film effects within 2 weeks prior to and during the study.

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

6. Any previous, or planned, ocular or interocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)

7. 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.

8. Any ocular infection.

9. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.

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

11. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

12. Employee of investigational clinic (e.g. Investigator, Coordinator, Technician).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aston University

Birmingham, West Midlands, United Kingdom

Countries

United Kingdom

Other Identifiers

CR-5815

Identifier Type: -

Identifier Source: org_study_id