CompletedNCT01180985Updated Jun 19, 2018Results posted

Dispensing Evaluation of a Galyfilcon A Prototype Lens and a Marketed Contact Lens

An interventional study of galyfilcon A prototype lens and comfilcon A in Myopia, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2018-06-19.

Sponsored by Johnson & Johnson Vision Care, Inc. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 53
Allocation: Randomized
Ages: 18 Years to 39 Years
Sex: All

Study summary

The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.

Conditions studied

Myopia

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Myopia 984

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 53 is below the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Johnson & Johnson Vision Care, Inc. is the lead sponsor of 220 studies on the registry; 2 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 101 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 39 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study.
The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
Any cylinder power must be ≤ -0.75D.
The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
The subject must read and sign the Statement of Informed Consent.
The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.

Exclusion criteria

Exclusion Criteria:

Ocular or systemic allergies or disease which might interfere with contact lens wear.
Systemic disease or use of medication which might interfere with contact lens wear.
Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
Any ocular infection.
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
Pregnancy or lactation.
Diabetes.
Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
Habitual contact lens type is toric, multifocal, or is worn as extended wear.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 53 participants (actual)

Study arms

Other
galyfilcon A prototype/comfilcon A
The galyfilcon A prototype lenses are worn during first period and comfilcon A lenses worn during second period. Each period consists of daily lens wear for one week.
Device: galyfilcon A prototype lens · Device: comfilcon A
Other
comfilcon A/galyfilcon A prototype
The comfilcon A lenses are worn during first period and galyfilcon A prototype lenses worn during second period. Each period consists of daily lens wear for one week.
Device: galyfilcon A prototype lens · Device: comfilcon A

Interventions

Devicegalyfilcon A prototype lens
silicone hydrogel contact lens
Devicecomfilcon A
silicone hydrogel contact lens
Also known as: Biofinity® contact lens

What researchers measure

Primary outcomes

Visual Acuity Monocular
Snellen monocular visual acuity measurement was measured in both eyes that wore lenses for one week and came in for the evaluation with an inserted lens.
Time frame: after 7 +/- 1 days of lens wear
Visual Acuity Binocular
Snellen binocular visual acuity measurement
Time frame: after 7 +/- 1 days of lens wear
Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.
The contract Lens Experience (CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Time frame: after 7 +/-1 days of lens wear
Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire.
Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Time frame: after 7 +/- 1 days of lens wear

Secondary outcomes

Limbal Redness
Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
Time frame: after 7 days of lens wear
Bulbar Redness
Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
Time frame: after 7 days of lens wear
Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.
Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Time frame: 10 minutes after lens insertion at time of initial lens fitting

Results

Posted Feb 5, 2014

Participant flow

This study was a four (4) site, bilateral crossover study. Data were collected in three (3) visits (initial, 1 wk follow-up, and final visit).

Period 1 (7 +/- Days)

Participant flow — Period 1 (7 +/- Days)
Milestone	Galyfilcon A (Test)/Comfilcon A (Control)	Comfilcon A (Control)/Galyfilcon A (Test)
Started	27	26
Completed	27	26
Not completed	0	0

Period 2 (7 +/- 1 Days)

Participant flow — Period 2 (7 +/- 1 Days)
Milestone	Galyfilcon A (Test)/Comfilcon A (Control)	Comfilcon A (Control)/Galyfilcon A (Test)
Started	27	26
Completed	26	26
Not completed	1	0
Withdrew: Lost to follow-up	1	0

Outcome measures

PrimaryVisual Acuity Monocular

Snellen monocular visual acuity measurement was measured in both eyes that wore lenses for one week and came in for the evaluation with an inserted lens.

Time frame:: after 7 +/- 1 days of lens wear
Reported as:: Number · eyes

Visual Acuity Monocular
eyes	Comfilcon A Lens (Control)	Galyfilcon A Lens (Test)
20/15 monocular	53	49
20/20 monocular	49	48
20/25 monocular	2	4
20/30 monocular	0	3

PrimaryVisual Acuity Binocular

Snellen binocular visual acuity measurement

Time frame:: after 7 +/- 1 days of lens wear
Reported as:: Number · participants

Visual Acuity Binocular
participants	Comfilcon A Lens (Control)	Galyfilcon A Lens (Test)
20/10 binocular	0	1
20/15 binocular	31	29
20/20 binocular	21	20
20/25 binocular	0	1
20/30 binocular	0	1

PrimarySubjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.

The contract Lens Experience (CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.

Time frame:: after 7 +/-1 days of lens wear
Reported as:: Least squares mean · CLUE score

Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.
CLUE score	Comfilcon A Lens (Control)	Galyfilcon A Lens (Test)
Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.	57.72 ± 4.47	67.06 ± 4.50

SecondaryLimbal Redness

Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.

Time frame:: after 7 days of lens wear
Reported as:: Number · eyes

Limbal Redness
eyes	Comfilcon A Lens (Control)	Galyfilcon A Lens (Test)
Grade 0 = No redness	37	36
Grade 1 = Trace redness	36	42
Grade 2 = Mild redness	31	26

PrimarySubjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire.

Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.

Time frame:: after 7 +/- 1 days of lens wear
Reported as:: Least squares mean · CLUE score

Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire.
CLUE score	Comfilcon A Lens (Control)	Galyfilcon A Lens (Test)
Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire.	62.75 ± 2.83	59.98 ± 2.81

SecondaryBulbar Redness

Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.

Time frame:: after 7 days of lens wear
Reported as:: Number · eyes

Bulbar Redness
eyes	Comfilcon A Lens (Control)	Galyfilcon A Lens (Test)
Grade 0 = No redness	39	37
Grade 1 = Trace redness	55	59
Grade 2 = Mild redness	10	8

SecondarySubjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.

Time frame:: 10 minutes after lens insertion at time of initial lens fitting
Reported as:: Mean · CLUE score

Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.
CLUE score	Comfilcon A Lens (Control)	Galyfilcon A Lens (Test)
Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.	80.32 ± 18.36	82.76 ± 17.01

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Galyfilcon A Prototype/Comfilcon A	—	0/53 (0%)	0/53 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	All Subjects
<=18 years	0
Between 18 and 65 years	53
>=65 years	0

Age, Continuous
Age, Continuous(years)	All Subjects
Mean	28.00 ± 5.82

Sex: Female, Male
Sex: Female, Male(Participants)	All Subjects
Female	37
Male	16

Region of Enrollment
Region of Enrollment(participants)	All Subjects
United States	53

Study locations

4 sites

Jacksonville, Florida, United States
Orlando, Florida, United States
Fincastle, Virginia, United States
Salem, Virginia, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01180985
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Responsible party: Sponsor
First posted: Aug 13, 2010
Start date: Jun 1, 2010
Primary completion: Jul 1, 2010
Completion: Jul 1, 2010
Results posted: Feb 5, 2014
Last update: Jun 19, 2018

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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