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Clinical Comparison of Two Daily Disposable Lenses Among Daily Disposable Lens Wearers

NCT ID: NCT01134211

Last Updated: 2016-11-21

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

NA

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-07-31

Brief Summary

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The primary objective of this trial is to evaluate the subjective performance of two different daily disposable contact lenses in a population of daily disposable lens wearers.

Detailed Description

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Conditions

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Myopia

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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nelfilcon A / filcon II 3

Nelfilcon A contact lenses worn first, with filcon II 3 contact lenses worn second. Both products worn in both eyes on a daily wear, daily disposable basis for one week each.

Group Type OTHER

nelfilcon A

Intervention Type DEVICE

Commercially marketed, single-vision, soft contact lens for daily disposable wear

filcon II 3

Intervention Type DEVICE

Commercially marketed, single-vision, soft contact lens for daily disposable wear

filcon II 3 / nelfilcon A

Filcon II 3 contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn in both eyes on a daily wear, daily disposable basis for one week each.

Group Type OTHER

nelfilcon A

Intervention Type DEVICE

Commercially marketed, single-vision, soft contact lens for daily disposable wear

filcon II 3

Intervention Type DEVICE

Commercially marketed, single-vision, soft contact lens for daily disposable wear

Interventions

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nelfilcon A

Commercially marketed, single-vision, soft contact lens for daily disposable wear

Intervention Type DEVICE

filcon II 3

Commercially marketed, single-vision, soft contact lens for daily disposable wear

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Currently wearing any spherical daily disposable lens in daily wear, daily disposable modality for at least 3 months prior to enrollment with the exception of the 2 study products
* Currently Wearing lenses at least 8 hrs/day and 5 days/week.

Exclusion Criteria

* Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in any clinical trial.
* Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
* Prior history of corneal or refractive surgery.
* Requires monovision correction.
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

Locations

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W.Hartwig - Qualität in jeder Hinsicht

Heikendorf, , Germany

Site Status

Countries

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Germany

References

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OVS, Marx et al. Subjective Performance of hydrogel and silicone hydrogel daily disposable contact lenses). AAO poster presentation 2014.

Reference Type RESULT

Other Identifiers

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P-337-C-033

Identifier Type: -

Identifier Source: org_study_id