MyopiaNCT01482312

Effect of Contact Lenses on Tear Osmolarity in a Controlled Low Humidity Chamber

A study testing lotrafilcon A contact lenses, comfilcon A contact lenses and Glasses in people with Myopia and Dry Eye, run by CIBA VISION at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate two different types of contact lenses and their effect on dry eyes when compared to wearing glasses in a controlled, low humidity chamber. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Myopia, Dry Eye
What is being tested?: lotrafilcon A contact lenses, comfilcon A contact lenses and Glasses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteCanada
Study dates: Dec 2010to Feb 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 to 70.
History of end-of-day or low-humidity dryness with contact lenses.
Healthy eyes.
Best-corrected visual acuity of 20/50 or better for each eye.
Usable pair of eye glasses.
Willing and able to attend required study visits.
Sign informed consent.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Ocular or systemic allergies or diseases which might interfere with contact lens wear.
Clinically significant ocular findings which would contraindicate contact lens wear.
Unable to abstain from artificial tears or other ophthalmic drops for at least 7 days.
Participation in another clinical study currently or within 30 days of study entry.
Spectacle astigmatism of >1.00 diopter.
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Cetero Research
Mississauga, Ontario, L4W 1N2

Other trials in Canada

About this study

The purpose of this study is to evaluate two different types of contact lenses and their effect on dry eyes when compared to wearing glasses in a controlled, low humidity chamber.

Conditions: Myopia, Dry Eye
Being tested: lotrafilcon A contact lenses, comfilcon A contact lenses, Glasses
Medical subject headings: Myopia, Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lotrafilcon A contact lensesDevice
Also called Air Optix Night and Day AQUA
Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
comfilcon A contact lensesDevice
Also called Biofinity
Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
GlassesOther
Glasses per habitual prescription

Study groups in NCT01482312
Study group	Role	What they receive
Lotrafilcon A / Comfilcon A / Glasses	Active comparator	Lotrafilcon A contact lenses worn first, followed by comfilcon A contact lenses, followed by habitual glasses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days. Receives: Device: lotrafilcon A contact lenses; Device: comfilcon A contact lenses; Other: Glasses
comfilcon A / glasses / lotrafilcon A	Active comparator	Comfilcon A contact lenses worn first, followed by glasses, followed by lotrafilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days. Receives: Device: lotrafilcon A contact lenses; Device: comfilcon A contact lenses; Other: Glasses
glasses / lotrafilcon A / comfilcon A	Active comparator	Glasses worn first, followed by lotrafilcon A contact lenses, followed by comfilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days. Receives: Device: lotrafilcon A contact lenses; Device: comfilcon A contact lenses; Other: Glasses

What is being measured

The primary outcome is the main question the study is designed to answer.

Tear Osmolarity
The participant spent 90 minutes in the LHE (low humidity environment) chamber, after which tears were sampled from the lower tear meniscus (thin strip of tear fluid at the lower lid margin) and tear osmolarity was measured using a TearLab osmometer, a device that measures the osmolarity of human tears to aid in the diagnosis of dry eye disease. Tear osmolarity is the measure of solid particles (salt) in a solution (tears), and a higher number can be indicative of dry eye disease, while a lower number is generally indicative of the normal tear osmolarity.
Measured: 90 minutes
Ocular Comfort
Ocular comfort was assessed by the participant after 90 minutes in the LHE and quantified as a linear measure (cm) on a modified Visual Analog Scale (VAS) of 0-20 cm, with a higher number indicating greater perceived comfort.
Measured: 90 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Feb 2011

First posted30 Nov 2011 (estimated)
Study startDec 2010
Primary completionFeb 2011
Study completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MyopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01482312
Sponsor's protocol ID: P-373-C-900
Status last verified: Jun 2012
First submitted: 28 Nov 2011
Last updated: 27 Jul 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Contact Lenses on Tear Osmolarity in a Controlled Low Humidity Chamber
ClinicalTrials.gov ID: NCT01482312
Acronym / sponsor ID: P-373-C-900
Conditions: Myopia, Dry Eye
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: CIBA VISIONIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 30 Nov 2011 (estimated)
Results: Posted 27 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate two different types of contact lenses and their effect on dry eyes when compared to wearing glasses in a controlled, low humidity chamber.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Lotrafilcon A / Comfilcon A / Glasses	Active comparator	Device: lotrafilcon A contact lenses, Device: comfilcon A contact lenses, Other: GlassesLotrafilcon A contact lenses worn first, followed by comfilcon A contact lenses, followed by habitual glasses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
comfilcon A / glasses / lotrafilcon A	Active comparator	Device: lotrafilcon A contact lenses, Device: comfilcon A contact lenses, Other: GlassesComfilcon A contact lenses worn first, followed by glasses, followed by lotrafilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
glasses / lotrafilcon A / comfilcon A	Active comparator	Device: lotrafilcon A contact lenses, Device: comfilcon A contact lenses, Other: GlassesGlasses worn first, followed by lotrafilcon A contact lenses, followed by comfilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age 18 to 70.
History of end-of-day or low-humidity dryness with contact lenses.
Healthy eyes.
Best-corrected visual acuity of 20/50 or better for each eye.
Usable pair of eye glasses.

Key exclusion criteria (6 listed)

Ocular or systemic allergies or diseases which might interfere with contact lens wear.
Clinically significant ocular findings which would contraindicate contact lens wear.
Unable to abstain from artificial tears or other ophthalmic drops for at least 7 days.
Participation in another clinical study currently or within 30 days of study entry.
Spectacle astigmatism of >1.00 diopter.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
lotrafilcon A contact lensesAlso: Air Optix Night and Day AQUACommercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.	Device	Lotrafilcon A / Comfilcon A / Glasses, comfilcon A / glasses / lotrafilcon A, glasses / lotrafilcon A / comfilcon A
comfilcon A contact lensesAlso: BiofinityCommercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.	Device	Lotrafilcon A / Comfilcon A / Glasses, comfilcon A / glasses / lotrafilcon A, glasses / lotrafilcon A / comfilcon A
GlassesGlasses per habitual prescription	Other	Lotrafilcon A / Comfilcon A / Glasses, comfilcon A / glasses / lotrafilcon A, glasses / lotrafilcon A / comfilcon A

Primary outcome

Tear Osmolarity
Time frame: 90 minutes
The participant spent 90 minutes in the LHE (low humidity environment) chamber, after which tears were sampled from the lower tear meniscus (thin strip of tear fluid at the lower lid margin) and tear osmolarity was measured using a TearLab osmometer, a device that measures the osmolarity of human tears to aid in the diagnosis of dry eye disease. Tear osmolarity is the measure of solid particles (salt) in a solution (tears), and a higher number can be indicative of dry eye disease, while a lower number is generally indicative of the normal tear osmolarity.
Ocular Comfort
Time frame: 90 minutes
Ocular comfort was assessed by the participant after 90 minutes in the LHE and quantified as a linear measure (cm) on a modified Visual Analog Scale (VAS) of 0-20 cm, with a higher number indicating greater perceived comfort.

Results and safety

Results posted to the registry on 27 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lotrafilcon A / Comfilcon A / Glasses	10	9
Comfilcon A / Glasses / Lotrafilcon A	9	9
Glasses / Lotrafilcon A / Comfilcon A	10	10

Primary outcome: Tear Osmolarity

Time frame: 90 minutes. Mean (Standard Deviation). Unit: mOsms/L

Measure	Lotrafilcon A Contact Lenses n = 27	Comfilcon A Contact Lenses n = 26	Glasses n = 27
Value	310 (11)	313 (9)	306 (11)

Population analysed: As treated.

Primary outcome: Ocular Comfort

Time frame: 90 minutes. Median (Standard Deviation). Unit: cm

Measure	Lotrafilcon A Contact Lenses n = 27	Comfilcon A Contact Lenses n = 27	Glasses n = 27
Value	9.4 (3.98)	8.2 (3.30)	9.7 (3.53)

Population analysed: As treated.

Adverse events

Time frame: Adverse events were collected for (duration). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lotrafilcon A Contact Lenses	0 of 28 (0%)	0 of 28 (0%)	Not reported
Comfilcon A Contact Lenses	0 of 27 (0%)	0 of 27 (0%)	Not reported
Glasses	0 of 27 (0%)	0 of 27 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
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High Myopia, Intraocular Pressure
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Deepen Patel, MD, CCFP principal investigator

Cetero Research, San Antonio

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing lotrafilcon A contact lenses, comfilcon A contact lenses and Glasses in people with Myopia and Dry Eye, run by CIBA VISION at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tear Osmolarity (time frame: 90 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01482312.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2012.