Dispensing Overnight Study in Lenses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-03-31

Brief Summary

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The purpose of the study is to evaluate the fit and performance of an investigational soft contact lens in comparison with a currently marketed lens. Both lenses will be worn on a continuous wear basis, which means the lenses will be worn while sleeping.

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Detailed Description

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The purpose of the study is to evaluate the fit and performance of an investigational soft contact lens in comparison with a currently marketed lens. Both lenses will be worn on a continuous wear basis, which means the lenses will be worn while sleeping. Physiological changes will be monitored and subjective ratings collected.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Biofinity

Intervention Type DEVICE

Soft contact lens

Interventions

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Biofinity

Soft contact lens

Intervention Type DEVICE

Other Intervention Names

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Purevision

Eligibility Criteria

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Inclusion Criteria

1. Has had an oculo-visual examination in the last 2 years.
2. Is between 18-45 years old and has full legal capacity to volunteer.
3. Has read and understood the Information Consent Letter
4. Is willing and able to follow participant instructions for product usage and meet the protocol-specified schedule of follow-up visits.
5. Is correctable with the prescription of the available lenses (-1.00 to -4.00 DS in 0.50D step).
6. Is correctable to at least 20/40 distance visual acuity with contact lenses in each eye.
7. Is a current soft contact lens wearer (both daily wear and extended wear experience allowed).
8. Has refractive astigmatism of \<= 1.00 diopters
9. Has clear corneas and ocular clinical findings considered to be "normal".

Exclusion Criteria

1. Has any systemic disease affecting ocular health.
2. Is using any systemic or topical medications that will affect ocular health.
3. Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
4. Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities.
5. Has limbal injection, bulbar injection or corneal staining that, in the Investigator's opinion, is clinically significant.
6. Has never worn contact lenses before.
7. Has corneal distortion resulting from rigid lens wear.
8. Is aphakic.
9. Has undergone corneal refractive surgery.
10. Is participating in any other type of clinical or research study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes