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Prospective Study of an Investigational Toric Soft Contact Lens

NCT ID: NCT01461811

Last Updated: 2013-10-17

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

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-04-30

Brief Summary

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The purpose of this study was to demonstrate substantial equivalence of an investigational toric soft contact lens to the commercially available Focus® DAILIES® Toric soft contact lens when worn in a daily wear, daily disposable mode for three months.

Detailed Description

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Eligible participants were randomized 2:1 to wear either DAILIES® AquaComfort Plus® Toric or Focus® DAILIES® Toric.

Conditions

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Myopia Astigmatism Refractive Error

Keywords

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toric contact lenses daily disposable contact lenses astigmatism soft contact lenses contact lens comfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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DAILIES® AquaComfort Plus® Toric

Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months

Group Type EXPERIMENTAL

Nelfilcon A toric contact lenses (with comfort additives)

Intervention Type DEVICE

Focus® DAILIES® Toric

Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months

Group Type ACTIVE_COMPARATOR

Nelfilcon A toric contact lenses

Intervention Type DEVICE

Interventions

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Nelfilcon A toric contact lenses (with comfort additives)

Intervention Type DEVICE

Nelfilcon A toric contact lenses

Intervention Type DEVICE

Other Intervention Names

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Focus® DAILIES® Toric

Eligibility Criteria

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Inclusion Criteria

* Sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and participant must sign Assent document.
* Normal eyes not using any ocular medications that would contraindicate lens wear.
* Willing and able to wear toric contact lenses in both eyes within the available range of powers for this trial.
* Spectacle cylinder prescription between 0.50 and 2.00 diopters.
* Best spectacle corrected visual acuity 20/25 (Snellen) or better in each eye at distance.

Exclusion Criteria

* Anterior segment infection, inflammation, or abnormality.
* Any active anterior segment or systemic disease that would contraindicate contact lens wear.
* Use of systemic medications that would contraindicate lens wear.
* Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study.
* History of herpetic keratitis.
* History of refractive surgery or irregular cornea.
* History of pathologically dry eye.
* Corneal vascularization greater than 1 mm of penetration.
* Eye injury within twelve weeks immediately prior to enrollment in this trial.
* Participation in a contact lens or contact lens care product clinical trial within the previous 30 days, or concurrent participation in any clinical trial.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CIBA VISION

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary Fahmy, OD

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

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C-11-035 (P-415-C-003)

Identifier Type: -

Identifier Source: org_study_id