Refractive ErrorNCT01198600

Ocular Comfort and the "Aging" Lens (ERBIUM)

A study testing Habitual contact lens, Lotrafilcon B contact lens and Contact lens cleaning and disinfecting system (ClearCare) in people with Refractive Error, 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 trial was to evaluate the factors affecting comfortable contact lens wear and how those factors affect contact lens replacement frequency. Read more about this study

Who is it for?: Ages 17 years and older
Conditions the study is for: Refractive Error
What is being tested?: Habitual contact lens, Lotrafilcon B contact lens and Contact lens cleaning and disinfecting system (ClearCare)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 1 siteCanada
Study dates: Jul 2010to Jul 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 17 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

At least 17 years of age.
Ocular exam in the last two years.
Currently wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis with a monthly replacement schedule.
Wearing contact lenses at least five days per week for a minimum of 10 hours each day.
Able to wear lenses in the available power range with a best-corrected visual acuity of at least 20/32 in both eyes.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Any ocular disease.
Systemic condition that may affect a study outcome.
Using any systemic or topical medications that may affect ocular health.
Wears lenses on an extended or continuous wear schedule.
Habitually wears multifocal lenses.
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

Canada1 site

University of Waterloo
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

The purpose of this trial was to evaluate the factors affecting comfortable contact lens wear and how those factors affect contact lens replacement frequency.

Read the detailed description

Eligible participants began Phase 1, following either Cycle A or Cycle B, and crossing over to the second cycle after completing the first. After the Phase 1 results were evaluated, eligible participants entered Phase 2. After Phase 2 results were evaluated, participants who consistently reported the highest and the lowest comfort scores entered Phase 3 and were defined as either survivors or strugglers.

Conditions: Refractive Error
Being tested: Habitual contact lens, Lotrafilcon B contact lens, Contact lens cleaning and disinfecting system (ClearCare)
Medical subject headings: Refractive Errors

What participants receive

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

Habitual contact lensDevice
Hydrogel or silicone hydrogel contact lens per participant's habitual brand and prescription
Lotrafilcon B contact lensDevice
Also called AIR OPTIX AQUA
Commercially marketed silicone hydrogel contact lens
Contact lens cleaning and disinfecting system (ClearCare)Device
Also called CLEARCARE
Commercially marketed, hydrogen peroxide-based contact lens care system

Study groups in NCT01198600
Study group	Role	What they receive
Phase 1: Habitual no Replacement, then Habitual Replacement	Other	Contact lenses per participant's habitual prescription worn for 30 days with no replacement, followed by contact lenses per habitual prescription worn for 30 days with a replacement pair dispensed at Day 28. Receives: Device: Habitual contact lens
Phase 1: Habitual Replacement, then Habitual no Replacement	Other	Contact lenses per participant's habitual prescription worn for 30 days with replacement pair dispensed at Day 28, followed by contact lenses per habitual prescription worn for 30 days with no replacement. Receives: Device: Habitual contact lens
Phase 2: Lotrafilcon B Replacement	Other	Contact lenses worn for 56 days with replacement pair dispensed at Day 28. Receives: Device: Lotrafilcon B contact lens; Device: Contact lens cleaning and disinfecting system (ClearCare)
Phase 3: Lotrafilcon B Replacement Replacement	Other	Contact lenses worn for 43 days with replacement pair dispensed at Day 1 and Day 28. Receives: Device: Lotrafilcon B contact lens; Device: Contact lens cleaning and disinfecting system (ClearCare)

What is being measured

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

Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Measured: Day 1
Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Measured: Day 1
Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Measured: Day 1
Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Measured: Day 15
Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Measured: Day 15
Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Measured: Day 15
Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Measured: Day 43
Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Measured: Day 43
Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Measured: Day 43

Timeline

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

Jul 2010Jul 2011

First posted10 Sep 2010 (estimated)
Study startJul 2010
Primary completionJul 2011
Study completionJul 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 Refractive ErrorStudies 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: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01198600
Sponsor's protocol ID: P-373-C-006
Status last verified: Jul 2012
First submitted: 9 Sep 2010
Last updated: 29 Aug 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 Refractive Error trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ocular Comfort and the "Aging" Lens (ERBIUM)
ClinicalTrials.gov ID: NCT01198600
Acronym / sponsor ID: P-373-C-006
Conditions: Refractive Error
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: CIBA VISIONIndustry (pharma, biotech, devices)
Collaborators: University of Waterloo
Study start: Jul 2010
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 10 Sep 2010 (estimated)
Results: Posted 29 Aug 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 trial was to evaluate the factors affecting comfortable contact lens wear and how those factors affect contact lens replacement frequency.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Phase 1: Habitual no Replacement, then Habitual Replacement	Other	Device: Habitual contact lensContact lenses per participant's habitual prescription worn for 30 days with no replacement, followed by contact lenses per habitual prescription worn for 30 days with a replacement pair dispensed at Day 28.
Phase 1: Habitual Replacement, then Habitual no Replacement	Other	Device: Habitual contact lensContact lenses per participant's habitual prescription worn for 30 days with replacement pair dispensed at Day 28, followed by contact lenses per habitual prescription worn for 30 days with no replacement.
Phase 2: Lotrafilcon B Replacement	Other	Device: Lotrafilcon B contact lens, Device: Contact lens cleaning and disinfecting system (ClearCare)Contact lenses worn for 56 days with replacement pair dispensed at Day 28.
Phase 3: Lotrafilcon B Replacement Replacement	Other	Device: Lotrafilcon B contact lens, Device: Contact lens cleaning and disinfecting system (ClearCare)Contact lenses worn for 43 days with replacement pair dispensed at Day 1 and Day 28.

Who may qualify

Ages: 17 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

At least 17 years of age.
Ocular exam in the last two years.
Currently wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis with a monthly replacement schedule.
Wearing contact lenses at least five days per week for a minimum of 10 hours each day.
Able to wear lenses in the available power range with a best-corrected visual acuity of at least 20/32 in both eyes.

Key exclusion criteria (6 listed)

Any ocular disease.
Systemic condition that may affect a study outcome.
Using any systemic or topical medications that may affect ocular health.
Wears lenses on an extended or continuous wear schedule.
Habitually wears multifocal lenses.

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
Habitual contact lensHydrogel or silicone hydrogel contact lens per participant's habitual brand and prescription	Device	Phase 1: Habitual Replacement, then Habitual no Replacement, Phase 1: Habitual no Replacement, then Habitual Replacement
Lotrafilcon B contact lensAlso: AIR OPTIX AQUACommercially marketed silicone hydrogel contact lens	Device	Phase 2: Lotrafilcon B Replacement, Phase 3: Lotrafilcon B Replacement Replacement
Contact lens cleaning and disinfecting system (ClearCare)Also: CLEARCARECommercially marketed, hydrogen peroxide-based contact lens care system	Device	Phase 2: Lotrafilcon B Replacement, Phase 3: Lotrafilcon B Replacement Replacement

Primary outcome

Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1
Time frame: Day 1
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10
Time frame: Day 1
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day
Time frame: Day 1
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1
Time frame: Day 15
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10
Time frame: Day 15
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day
Time frame: Day 15
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1
Time frame: Day 43
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10
Time frame: Day 43
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day
Time frame: Day 43
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")

Results and safety

Results posted to the registry on 29 Aug 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
Phase 1: Habitual no Replacement, Then Habitual Replacement	35	33
Phase 1: Habitual Replacement, Then Habitual no Replacement	37	36
Phase 2: Lotrafilcon B Replacement	0	0
Phase 3: Lotrafilcon B Replacement Replacement	0	0

Primary outcome: Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1

Time frame: Day 1. Mean (Standard Deviation). Unit: Units on a scale

Measure	Survivors: Lotrafilcon B/Replacement/Replacement n = 22	Strugglers: Lotrafilcon B/Replacement/Replacement n = 16
Value	76 (14)	88 (14)

Population analysed: All enrolled and dispensed participants, Phase 3.

Primary outcome: Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10

Time frame: Day 1. Mean (Standard Deviation). Unit: Units on a scale

Measure	Survivors: Lotrafilcon B/Replacement/Replacement n = 22	Strugglers: Lotrafilcon B/Replacement/Replacement n = 16
Value	69 (19)	76 (19)

Population analysed: All enrolled and dispensed participants, Phase 3.

Primary outcome: Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day

Time frame: Day 1. Mean (Standard Deviation). Unit: Units on a scale

Measure	Survivors: Lotrafilcon B/Replacement/Replacement n = 22	Strugglers: Lotrafilcon B/Replacement/Replacement n = 16
Value	65 (21)	67 (21)

Population analysed: All enrolled and dispensed participants, Phase 3.

Primary outcome: Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1

Time frame: Day 15. Mean (Standard Deviation). Unit: Units on a scale

Measure	Survivors: Lotrafilcon B/Replacement/Replacement n = 22	Strugglers: Lotrafilcon B/Replacement/Replacement n = 16
Value	80 (14)	79 (14)

Population analysed: All enrolled and dispensed participants, Phase 3.

Adverse events

Time frame: Adverse events were collected for the duration of the study: 8-JUL-2010 to 19-JUL-2011.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Habitual Contact Lens	0 of 78 (0%)	0 of 78 (0%)	Not reported
Lotrafilcon B Contact Lens	0 of 67 (0%)	0 of 67 (0%)	Not reported

Limitations and caveats (from the sponsor): The current study design and sample size was not able to uncover clinically meaningful differences between survivors and strugglers. There is considerable individual variation in lens performance with age, which requires further investigation.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Desmond Fonn, MOptom FAAO study director

University of Waterloo Centre for Contact Lens Research

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

Questions about this trial

What is this clinical trial studying?

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 6 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 29 Aug 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 29 Aug 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?

Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1 (time frame: Day 1). The study lists 9 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 NCT01198600.

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 29 Aug 2012.