CompletedNCT00810511Updated Dec 5, 2023Results posted

Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period

An interventional study of Lotrafilcon A contact lens and Comfilcon A contact lens in Myopia, sponsored by CIBA VISION. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-05.

Sponsored by CIBA VISION (part of Alcon) · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 213
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this trial is to compare two different contact lenses during 4 weeks of wear.

Conditions studied

Myopia

Browse trials for

Myopia 1,007

In context

Myopia

1,007 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 213 is above the median of 80 across 803 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

CIBA VISION is the lead sponsor of 52 studies on the registry; none are open to participants now.

First submitted before CIBA VISION became part of Alcon.

Browse CIBA VISION studies →All Alcon studies →

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Current soft contact lens wearer who wear their habitual lenses for no less than 10 hours a day, 5 days a week
Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye while wearing trial lenses
Replace lenses on a weekly or longer schedule
Other protocol inclusion/exclusion criteria may apply

Exclusion criteria

Exclusion Criteria:

Requires concurrent ocular medication
Eye injury or surgery within twelve weeks immediately prior to enrollment
Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions
Current soft toric lens wearers
Those who dispose of their soft lenses on a daily basis
Current NIGHT \& DAY® or Biofinity® lens wearers
Other protocol-defined inclusion/exclusion criteria may apply

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 213 participants (actual)

Study arms

Experimental
Lotrafilcon A
Investigational, spherical, silicone hydrogel contact lenses
Device: Lotrafilcon A contact lens
Active comparator
Comfilcon A
Commercially marketed, spherical, silicone hydrogel contact lenses
Device: Comfilcon A contact lens

Interventions

DeviceLotrafilcon A contact lens
Silicone hydrogel contact lens
DeviceComfilcon A contact lens
Silicone hydrogel contact lens

What researchers measure

Primary outcomes

Comfort at End of Day
Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: After 4 weeks of wear

Results

Posted Oct 1, 2010

Participant flow

Participant flow — Overall Study
Milestone	Lotrafilcon A	Comfilcon A
Started	107	106
Completed	97	102
Not completed	10	4
Withdrew: Protocol violation	0	1
Withdrew: Lack of efficacy	9	1
Withdrew: Death in the family	0	1
Withdrew: Lost to follow-up	1	0
Withdrew: Deposits on contact lens	0	1

Outcome measures

PrimaryComfort at End of Day

Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent.

Time frame:: After 4 weeks of wear
Reported as:: Mean · Scale of 1-10

Comfort at End of Day
Scale of 1-10	Lotrafilcon A	Comfilcon A
Comfort at End of Day	6.5 ± 2.4	6.9 ± 2.4

Adverse events

Collected over 8 weeks, duration of the study. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Lotrafilcon A	—	0/107 (0%)	0/107 (0%)
Comfilcon A	—	0/106 (0%)	0/106 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Lotrafilcon A	Comfilcon A	Total
<=18 years	11	10	21
Between 18 and 65 years	96	96	192
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	Lotrafilcon A	Comfilcon A	Total
Mean	30.6 ± 9.8	31.8 ± 11.0	31.2 ± 10.4

Sex: Female, Male
Sex: Female, Male(Participants)	Lotrafilcon A	Comfilcon A	Total
Female	84	84	168
Male	23	22	45

Region of Enrollment
Region of Enrollment(participants)	Lotrafilcon A	Comfilcon A	Total
United States	107	106	213

Study locations

No study locations are listed for this record.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2008, a primary completion of Jan 2009 and a completion of Jan 2009. It does not say whether these dates are actual or estimated.

Results were first posted in Oct 2010, 1 year 9 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Dec 17, 2008
First posted: Dec 18, 2008
Start: Nov 2008
Primary completionActual: Jan 2009
CompletionActual: Jan 2009
Results first posted: Oct 1, 2010
Last update: Dec 5, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00810511
Lead sponsor: CIBA VISION
Responsible party: Sponsor
First posted: Dec 18, 2008
Start date: Nov 2008
Primary completion: Jan 2009
Completion: Jan 2009
Results posted: Oct 1, 2010
Last update: Dec 5, 2023

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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