Brief Summary

The purpose of this investigation is to compare the fit characteristics and vision attributes of an investigational Galyfilcon A contact lens and an approved Galyfilcon A contact lens.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Nov 2009

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4 months study duration

Study Start

First participant enrolled

November 1, 2009

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed

1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed

Last Updated

June 19, 2018

Status Verified

June 1, 2017

Enrollment Period

4 months

First QC Date

January 21, 2010

Last Update Submit

June 18, 2018

Conditions

Myopia

Outcome Measures

Primary Outcomes (3)

Comparison of Lens Fit Characteristics
At the screening visit, the following baseline measurements will be taken of the subject's habitual contact lenses (Control): * Visual Acuity (logMar) * Over-refraction with Visual Acuity * Fit acceptability (acceptable/non-acceptable)
Approximately 40 minutes of wear time
Evaluation of Inter-Changeability
In a bilateral fashion, the subject will wear Test/Control lens according to a pre-designed randomization schedule. Immediately upon insertion, the following variables will be assessed: * Ease of handling of the lenses- by Investigator * Comfort on insertion After 30-40 minutes of settling time the following variables will be collected: * Subjective comfort after settling * Visual Acuity (logMar) * Corneal coverage (Y/N) * Post-blink movement (mm) * Version Lag (mm) * Tightness on push-up (0-100 scale) * Overall fit acceptance (0-5 scale)
Approximately 40 minutes of wear time
Determination of fit or Vision Differences
In a bilateral fashion, the subject will wear Test/Control lens according to a pre-designed randomization schedule. Immediately upon insertion, the following variables will be assessed: * Ease of handling of the lenses- by Investigator * Comfort on insertion After 30-40 minutes of settling time the following variables will be collected: * Subjective comfort after settling * Visual Acuity (logMar) * Corneal coverage (Y/N) * Post-blink movement (mm) * Version Lag (mm) * Tightness on push-up (0-100 scale) * Overall fit acceptance (0-5 scale)
Approximately 40 minutes of wear time

Study Arms (6)

GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3

OTHER

Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)