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Evaluation of Vision Effects of a Cosmetic Tinted Hydrogel Contact Lens

NCT ID: NCT02886923

Last Updated: 2019-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2017-01-23

Brief Summary

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Subjects will wear 2 of 2 study contact lenses for a wearing time of approximately three to four hours at each of the visits in order to take measurements on binocular functional visual performance.

Detailed Description

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Conditions

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Refractive Error

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Test/Control Sequence

Subjects will wear the Hioxifilcon A Test contact lens and then the Hioxifilcon A with Cosmetic Ring Control contact lens for approximately three to four hours at each of the two measurement visits.

Group Type EXPERIMENTAL

Hioxifilcon A Test

Intervention Type DEVICE

contact lens made with hioxifilcon A material

Hioxifilcon A With Cosmetic Ring Control

Intervention Type DEVICE

contact lens made with hioxifilcon A material with a cosmetic ring on the lens

Control/Test Sequence

Subjects will wear the Hioxifilcon A with Cosmetic Ring Control contact lens and then the Hioxifilcon A Test contact lens for approximately three to four hours at each of the two measurement visits.

Group Type ACTIVE_COMPARATOR

Hioxifilcon A Test

Intervention Type DEVICE

contact lens made with hioxifilcon A material

Hioxifilcon A With Cosmetic Ring Control

Intervention Type DEVICE

contact lens made with hioxifilcon A material with a cosmetic ring on the lens

Interventions

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Hioxifilcon A Test

contact lens made with hioxifilcon A material

Intervention Type DEVICE

Hioxifilcon A With Cosmetic Ring Control

contact lens made with hioxifilcon A material with a cosmetic ring on the lens

Intervention Type DEVICE

Eligibility Criteria

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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 35 and 42 years of age (inclusive).
4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -6.00 Diopters (D) to +4.00 D in each eye.
5. The subject's refractive cylinder must be ≤ 0.75 D in each eye.
6. The subject must have best corrected visual acuity of 20/30 or better in each eye.
7. The subject must be an adapted soft contact lens wearer in both eyes (defined as a minimum of 6 hours of Daily Wear (DW) 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

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 infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV) by self-report.
4. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
5. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
6. Any ocular infection.
7. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
8. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
9. Habitual contact lens type is toric, bifocal, in monovision contact lens wear, or is worn as extended wear.
10. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
11. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Minimum Eligible Age

35 Years

Maximum Eligible Age

42 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Optometry Technology Group, Ltd.

London, , United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CR-5856

Identifier Type: -

Identifier Source: org_study_id