Contact Lenses With New UV-blocker Manufactured With Different Techniques

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-19

Study Completion Date

2018-04-18

Brief Summary

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This study is a randomized, 4-visit, double-masked, 2x3 bilateral crossover, dispensing trial. The study lenses will be worn as daily wear (DW) for a period of two weeks each with one of the study lenses being worn twice. Each study lens is expected to be worn at least five (5) days per week for at least six (6) hours per day worn. There will be no washout period between study lenses.

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Detailed Description

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Conditions

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Correction of Refraction Error Attenuation of Bright Light

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TEST/CONTROL/CONTROL

Subjects that are of 18 years or older and current spherical soft contact lens wearers will wear the Test and Control lenses for two weeks each in random order with one of the study lenses being worn twice for a total of 6 weeks per subject.

Group Type EXPERIMENTAL

senofilcon A TEST Lens

Intervention Type DEVICE

senofilcon A with new UV blocker investigational process

senofilcon A CONTROL Lens

Intervention Type DEVICE

senofilcon A with new UV blocker standard process

CONTROL/TEST/TEST

Subjects that are of 18 years or older and current spherical soft contact lens wearers will wear the Test and Control lenses for two weeks each in random order with one of the study lenses being worn twice for a total of 6 weeks per subject.

Group Type EXPERIMENTAL

senofilcon A TEST Lens

Intervention Type DEVICE

senofilcon A with new UV blocker investigational process

senofilcon A CONTROL Lens

Intervention Type DEVICE

senofilcon A with new UV blocker standard process

Interventions

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senofilcon A TEST Lens

senofilcon A with new UV blocker investigational process

Intervention Type DEVICE

senofilcon A CONTROL Lens

senofilcon A with new UV blocker standard process

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Healthy adult males or females age ≥18 years of age with signed informed consent.
4. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them.
5. The subject is a current spherical 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) and willing to wear the study lenses on a similar basis.
6. Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week.
7. The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 (inclusive) in each eye.
8. The subject's refractive cylinder must be ≤ -1.00 D in each eye.
9. Have spherocylindrical best corrected visual acuity of 20/25+3 or better in each eye.

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 active or ongoing 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 bodily diseases or infections, 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. Habitual medications taken by successful contact lens wearers are generally considered acceptable.
4. Habitual toric, extended wear, or multifocal contact lens wear.
5. Any current use of ocular medication.
6. Any known hypersensitivity or allergic reaction to Optifree PureMoist.
7. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
8. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
9. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
10. Any active or ongoing 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.
11. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA slit-lamp scale.
12. Binocular vision abnormality or strabismus.
13. 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 would contraindicate contact lens wear.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes