Refractive ErrorNCT01996709

Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers

A study testing Hydrogen peroxide-based contact lens solution, Habitual contact lens solution and Habitual contact lenses in people with Refractive Error, run by Alcon Research.

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 assess improvement of palpebral roughness and associated symptoms with 3 months use of Clear Care®. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Refractive Error
What is being tested?: Hydrogen peroxide-based contact lens solution, Habitual contact lens solution and Habitual contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 142 participants
Where: No sites listed yet
Study dates: Dec 2013to May 2014
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Current biweekly or monthly silicone hydrogel contact lens wearer (excluding Air Optix® brand) and have worn these lenses bilaterally for at least three (3) months prior to Visit 1 (daily wear use only).
Symptoms of contact lens discomfort as defined by the protocol.
Habitual use of a biguanide-preserved multi-purpose solution for at least 30 days prior to Visit 1.
Mild to severe (grade 2-4) Investigator rated palpebral roughness in one or more zones of either eye.
Other protocol-specified inclusion criteria may apply.

Who cannot join

Extended (over-night) contact lens wearer.
Any systemic or ocular disease or disorder (refractive disorder allowed and mild dry eye with successful contact lens wear is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
Topical ocular over the counter (OTC) or prescribed medications, with the exception of contact lens rewetting drops, within 7 days of enrollment.
Other protocol-specified exclusion criteria may apply.

About this study

The purpose of this study is to assess improvement of palpebral roughness and associated symptoms with 3 months use of Clear Care®.

Conditions: Refractive Error
Being tested: Hydrogen peroxide-based contact lens solution, Habitual contact lens solution, Habitual contact lenses
Keywords: Silicone hydrogel contact lenses, Multi-purpose solution, Lid Papillae, Palpebral Roughness
Medical subject headings: Refractive Errors

What participants receive

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

Hydrogen peroxide-based contact lens solutionDevice
Also called Clear Care®
Habitual contact lens solutionDevice
Biguanide-preserved
Habitual contact lensesDevice
Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule

Study groups in NCT01996709
Study group	Role	What they receive
Clear Care	Experimental	Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days Receives: Device: Hydrogen peroxide-based contact lens solution; Device: Habitual contact lenses
Habitual MPS	Active comparator	Habitual contact lens solution used with habitual contact lenses for 90 days Receives: Device: Habitual contact lens solution; Device: Habitual contact lenses

What is being measured

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

Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90
Lid papillae (bumps on the inner eyelid) were assessed by the investigator using slit-lamp biomicroscopy and classified independently for the four palpebral zones (upper lid=1-3; lower lid=4) on a 5-point forced choice scale, where 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse \& tufts papillae); 3 = Moderate (moderate \& tufts papillae); 4 = Severe (giant papillae). The maximum of the four zones was selected for the analysis. Both eyes were included in the model for analysis. A higher change value indicates a larger reduction in the severity of the lid papillae.
Measured: Baseline (Day 0), Day 90

Secondary outcomes (3)

Top 2 Box Percentage Agreement for "My Lenses Feel Like New" at Day 90
As interpreted and reported by the subject on a questionnaire. A 5-point Likert scale was used, where 1=strongly disagree; 2=disagree; 3=undecided; 4=agree; 5=strongly agree. The Top-2-box response (agree, strongly agree) was calculated and reported as a percentage of all responses.
Measured: Day 90
Mean Frequency Score for Symptoms of Grittiness at Day 90
As interpreted and reported by the subject on a questionnaire. The subject was asked, "During a typical day in the past 2 weeks, how often did your eyes feel gritty and/or scratchy while wearing your contact lenses?" and responded on a 5-point scale (1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Frequently; 5 = Constantly).
Measured: Day 90
Mean Frequency Score for Symptoms of Dryness at Day 90
As reported and interpreted by the subject on a questionnaire. The subject was asked "During a typical day in the past 2 weeks, how often did your eyes feel dry?" and responded on a 5-point scale ((0 = Never; 1 = Rarely; 2 = Sometimes; 3 = Frequently; 4 = Constantly).
Measured: Day 90

Timeline

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

Dec 2013May 2014

First posted27 Nov 2013 (estimated)
Study startDec 2013
Primary completionMay 2014
Study completionMay 2014

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.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01996709
Sponsor's protocol ID: A01337
Status last verified: May 2015
First submitted: 18 Nov 2013
Last updated: 8 Jun 2015
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?

Official record

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All Refractive Error trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers
ClinicalTrials.gov ID: NCT01996709
Acronym / sponsor ID: A01337
Conditions: Refractive Error
Keywords: Silicone hydrogel contact lenses, Multi-purpose solution, Lid Papillae, Palpebral Roughness
Study type: Interventional
Recruitment status: Completed
Enrolment: 142 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Dec 2013
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 27 Nov 2013 (estimated)
Results: Posted 8 Jun 2015

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 assess improvement of palpebral roughness and associated symptoms with 3 months use of Clear Care®.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Clear Care	Experimental	Device: Hydrogen peroxide-based contact lens solution, Device: Habitual contact lensesHydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
Habitual MPS	Active comparator	Device: Habitual contact lens solution, Device: Habitual contact lensesHabitual contact lens solution used with habitual contact lenses for 90 days

Who may qualify

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

Key inclusion criteria (5 listed)

Current biweekly or monthly silicone hydrogel contact lens wearer (excluding Air Optix® brand) and have worn these lenses bilaterally for at least three (3) months prior to Visit 1 (daily wear use only).
Symptoms of contact lens discomfort as defined by the protocol.
Habitual use of a biguanide-preserved multi-purpose solution for at least 30 days prior to Visit 1.
Mild to severe (grade 2-4) Investigator rated palpebral roughness in one or more zones of either eye.
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (4 listed)

Extended (over-night) contact lens wearer.
Any systemic or ocular disease or disorder (refractive disorder allowed and mild dry eye with successful contact lens wear is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
Topical ocular over the counter (OTC) or prescribed medications, with the exception of contact lens rewetting drops, within 7 days of enrollment.
Other protocol-specified exclusion criteria may apply.

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
Hydrogen peroxide-based contact lens solutionAlso: Clear Care®	Device	Clear Care
Habitual contact lens solutionBiguanide-preserved	Device	Habitual MPS
Habitual contact lensesSilicone hydrogel contact lenses with a biweekly or monthly replacement schedule	Device	Clear Care, Habitual MPS

Primary outcome

Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90
Time frame: Baseline (Day 0), Day 90
Lid papillae (bumps on the inner eyelid) were assessed by the investigator using slit-lamp biomicroscopy and classified independently for the four palpebral zones (upper lid=1-3; lower lid=4) on a 5-point forced choice scale, where 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse \& tufts papillae); 3 = Moderate (moderate \& tufts papillae); 4 = Severe (giant papillae). The maximum of the four zones was selected for the analysis. Both eyes were included in the model for analysis. A higher change value indicates a larger reduction in the severity of the lid papillae.

3 secondary outcomes

Top 2 Box Percentage Agreement for "My Lenses Feel Like New" at Day 90
Time frame: Day 90
Mean Frequency Score for Symptoms of Grittiness at Day 90
Time frame: Day 90
Mean Frequency Score for Symptoms of Dryness at Day 90
Time frame: Day 90

Results and safety

Results posted to the registry on 8 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Clear Care	66	61
Habitual MPS	68	67

Primary outcome: Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90

Time frame: Baseline (Day 0), Day 90. Mean (Standard Deviation). Unit: units on a scale

Measure	Clear Care, Right Eye n = 64	Clear Care, Left Eye n = 64	Habitual MPS, Right Eye n = 67	Habitual MPS, Left Eye n = 67
Baseline (Day 0)	2.3 (0.54)	2.3 (0.62)	2.2 (0.54)	2.2 (0.54)
Change from baseline at Day 90 (n=61, 61, 67, 67)	0.9 (0.74)	0.9 (0.81)	0.5 (0.56)	0.3 (0.69)

Population analysed: This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed. Here, "n" is subjects with non-missing values at the specific time point for each arm group, respectively.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of the study (DEC 2013 - MAY 2014). This analysis group includes all subjects who were exposed to a study regimen.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Clear Care	0 of 66 (0%)	0 of 66 (0%)	Not reported
Habitual MPS	0 of 68 (0%)	0 of 68 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Refractive Error

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
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
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.

Lisa Zoota, MPH study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing Hydrogen peroxide-based contact lens solution, Habitual contact lens solution and Habitual contact lenses in people with Refractive Error, run by Alcon Research.

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 5 inclusion and 4 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 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

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 8 Jun 2015). 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?

Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90 (time frame: Baseline (Day 0), Day 90). 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 NCT01996709.

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 8 Jun 2015.