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Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Lens Wearers

Primary Purpose

Myopia

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Nelfilcon A contact lens

Narafilcon A contact lens

Etafilcon A contact lens

Omafilcon A contact lens

Hilafilcon B contact lens

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Currently wear spherical, soft contact lenses replaced at intervals of 2 weeks or monthly.
Habitually wear lenses for at least 8 hours per day, 4 days per week, for at least the past 6 months.
Report 2 or more qualifying symptoms with current contact lenses with a frequency of "frequently" or "all the time"
Able to achieve VA of at least 20/40 in each eye with habitual correction and with study lenses at dispense.
Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

Eye injury or surgery within twelve weeks immediately prior to enrollment.
Currently enrolled in any clinical trial.
Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
History of corneal refractive surgery.
Cylinder correction greater than 1.00 D.
Current monovision contact lens wearers.
Other protocol inclusion/exclusion criteria may apply.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

Nelfilcon A

Narafilcon A

Etafilcon A

Omafilcon A

Hilafilcon B

Arm Description

Nelfilcon A contact lens

Narafilcon A contact lens

Etafilcon A contact lens

Omafilcon A contact lens

Hilafilcon B contact lens

Outcomes

Primary Outcome Measures

Lens Awareness

Lens awareness, as interpreted by the subject, was reported by the subject as a single, retrospective evaluation of 4 week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being all the time. Four-week ratings were compared to baseline ratings, and a negative difference (4-week minus baseline) represented an improvement.

Secondary Outcome Measures

Full Information

NCT ID

NCT00953407

First Posted

July 8, 2009

Last Updated

June 26, 2012

Sponsor

CIBA VISION

1. Study Identification

Unique Protocol Identification Number

NCT00953407

Brief Title

Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Lens Wearers

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CIBA VISION

4. Oversight

5. Study Description

Brief Summary

The purpose of this trial is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of 5 different daily disposable contact lenses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

128 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nelfilcon A

Arm Type

Experimental

Arm Description

Nelfilcon A contact lens

Arm Title

Narafilcon A

Arm Type

Active Comparator

Arm Description

Narafilcon A contact lens

Arm Title

Etafilcon A

Arm Type

Active Comparator

Arm Description

Etafilcon A contact lens

Arm Title

Omafilcon A

Arm Type

Active Comparator

Arm Description

Omafilcon A contact lens

Arm Title

Hilafilcon B

Arm Type

Active Comparator

Arm Description

Hilafilcon B contact lens

Intervention Type

Device

Intervention Name(s)

Nelfilcon A contact lens

Intervention Description