CompletedNCT00762996Updated Jun 19, 2018Results posted

The Clinical Evaluation of Two Daily Disposable Contact Lenses

An interventional study of etafilcon A and omafilcon A in Myopia, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. 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: 65
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.

Conditions studied

Myopia

Browse trials for

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 65 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 and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

They are of legal age (18 years) and capacity to volunteer.
They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They would be expected to attain at least 6.9 (20/30) in each eye with the study lenses.
They are able to wear contact lenses which have a back vertex power of -1.00 to -6.00DS.
They have a maximum of 1.00D of refractive astigmatism (i.e. \< 1.00 DC).
They have worn soft contact lenses within six months of starting the study.

Exclusion criteria

Exclusion Criteria:

They have an ocular disorder which would normally contra-indicate contact lens wear.
They have a systemic disorder which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They are aphakic.
They have had corneal refractive surgery.
They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
They are pregnant or lactating.
They have grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
They have any infectious disease (e.g., hepatitis) or any immunosuppressive disease (e.g., HIV).
They have diabetes.
They are currently taking part in any other clinical study or research.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Participant)
Enrollment: 65 participants (actual)

Study arms

Active comparator
etafilcon A/etafilcon A
Period 1: etafilcon A, Period 2: etafilcon A
Device: etafilcon A
Active comparator
etafilcon A/omafilcon A
Period 1: etafilcon A, Period 2: omafilcon A
Device: etafilcon A · Device: omafilcon A
Active comparator
omafilcon A/etafilcon A
Period 1: omafilcon A, Period 2: etafilcon A
Device: etafilcon A · Device: omafilcon A
Active comparator
omafilcon A/omafilcon A
Period 1: omafilcon A, Period 2: omafilcon A
Device: omafilcon A

Interventions

Deviceetafilcon A
contact lens
Deviceomafilcon A
contact lens

What researchers measure

Primary outcomes

Distance Visual Acuity
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Time frame: 1 week

Secondary outcomes

Lens Comfort
A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.\>0 = comfortable, \<0 = uncomfortable
Time frame: 1 week

Results

Posted Jun 23, 2009

Participant flow

Period One

Participant flow — Period One
Milestone	Etafilcon A / Etafilcon A	Etafilcon A / Omafilcon A	Omafilcon A / Etafilcon A	Omafilcon A / Omafilcon A
Started	15	16	17	17
Completed	15	16	13	16
Not completed	0	0	4	1
Withdrew: Protocol violation	0	0	1	0
Withdrew: Ineligible	0	0	1	1
Withdrew: Adverse event	0	0	1	0
Withdrew: Withdrawal by subject	0	0	1	0

Period Two

Participant flow — Period Two
Milestone	Etafilcon A / Etafilcon A	Etafilcon A / Omafilcon A	Omafilcon A / Etafilcon A	Omafilcon A / Omafilcon A
Started	15	16	13	16
Completed	15	16	13	16
Not completed	0	0	0	0

Outcome measures

PrimaryDistance Visual Acuity

logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.

Time frame:: 1 week
Reported as:: Least squares mean · logMar

Distance Visual Acuity
logMar	Etafilcon A	Omafilcon A
Distance Visual Acuity	0.03460 ± 0.007129	0.02931 ± 0.006666

Statistical analysis

Etafilcon A vs Omafilcon A · Mixed Models Analysis · Mean difference (final values): 0.005287 · 95% CI -0.01389 to 0.2447logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.

SecondaryLens Comfort

A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.\>0 = comfortable, \<0 = uncomfortable

Time frame:: 1 week
Reported as:: Least squares mean · Units on a scale

Lens Comfort
Units on a scale	Etafilcon A	Omafilcon A
Lens Comfort	0.3113 ± 0.1765	-0.1645 ± 0.2075

Statistical analysis

Etafilcon A vs Omafilcon A · Mixed Models Analysis · Mean difference (final values): 0.4757 · 95% CI 0.05563 to 0.4757Mean difference is etafilcon A minus omafilcon A.

Adverse events

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

Adverse event summary by group
Group	Deaths	Serious	Other
Etafilcon A / Etafilcon A	—	0/15 (0%)	0/15 (0%)
Etafilcon A / Omafilcon A	—	0/10 (0%)	0/10 (0%)
Omafilcon A / Etafilcon A	—	0/17 (0%)	0/17 (0%)
Omafilcon A / Omafilcon A	—	0/17 (0%)	0/17 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Entire Population
Mean	28.9 ± 5.3

Sex: Female, Male
Sex: Female, Male(Participants)	Entire Population
Female	41
Male	24

Study locations

1 site

Eurolens Research
Manchester, M60 1QD, United Kingdom

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: NCT00762996
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Collaborators: Eurolens Research
Responsible party: Sponsor
First posted: Sep 30, 2008
Start date: Aug 2007
Primary completion: Oct 2007
Completion: Oct 2007
Results posted: Jun 23, 2009
Last update: Jun 19, 2018

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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