Dry Eye SyndromeNCT01614600

Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers

A study testing Nelfilcon A contact lenses in people with Dry Eye Syndrome and Myopia, run by Alcon Research.

Completed

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

Trial summary

The purpose of this study was to evaluate the reduction of contact lens-related dryness symptoms when symptomatic weekly/monthly contact lens wearers were switched to DAILIES® AquaComfort Plus® lenses for a two-week period using composite scores on the Contact Lens Dry Eye Questionnaire (CLDEQ). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Syndrome, Myopia
What is being tested?: Nelfilcon A contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: No sites listed yet
Study dates: Jun 2012to Sep 2012
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

Currently wearing weekly/monthly, silicone hydrogel or traditional hydrogel soft contact lenses at least 8 hours per day and 5 days a week during the past 6 months.
Identified as symptomatic using a baseline screening questionnaire.
Requires vision correction in both eyes with a contact lens prescription as follows: sphere powers between -0.50 and -10.00 diopter (D) and cylinder powers </= 0.75D and no ADD correction.
Able to achieve visual acuity (VA) of at least 6/7.5 in each eye with study lenses in the available parameters.
Willing to wear study lenses for at least 8 hours/day and at least 5 days/week and discard the lenses at the end of the day and replace lenses every day with a new fresh pair.
Willing and able to follow instructions and maintain the appointment schedule.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Neophytes and current wearers of daily disposable contact lenses.
Requires monovision correction.
Any systemic or ocular disease or disorder (refractive disorder allowed) complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
A history of ocular surgery/trauma within the last 6 months.
Unwilling to discontinue mechanical eyelid therapy or eyelid scrubs within 14 days of enrollment and continuing during the study.
Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
Other protocol-defined exclusion criteria may apply.

About this study

Conditions: Dry Eye Syndrome, Myopia
Being tested: Nelfilcon A contact lenses
Keywords: contact lens, dry eye syndrome, symptomatic, daily disposable, myopia
Medical subject headings: Dry Eye Syndromes, Myopia

What participants receive

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

Nelfilcon A contact lensesDevice
Also called DAILIES® AquaComfort Plus®
Commercially marketed hydrogel contact lenses for daily wear, daily disposable use

Study groups in NCT01614600
Study group	Role	What they receive
DAILIES® AquaComfort Plus®	Experimental	Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks Receives: Device: Nelfilcon A contact lenses

What is being measured

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

Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2
Contact lens symptoms were evaluated using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects rated 8 common contact lens-related ocular surface dryness symptoms at Baseline, Week 1, and Week 2 using a 5-point scale (1=never or not at all intense, 5=constantly or very intense). A scoring algorithm was used to calculate a composite score for each visit for all symptoms (-6.5 to 10). A higher composite score would indicate more contact lens related dry eye and a lower score, less contact lens related dry eye.
Measured: Baseline, Week 1, Week 2

Timeline

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

Jun 2012Sep 2012

First posted8 Jun 2012 (estimated)
Study startJun 2012
Primary completionSep 2012
Study completionSep 2012

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 Dry Eye SyndromeStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01614600
Sponsor's protocol ID: A00849
Status last verified: Sep 2013
First submitted: 6 Jun 2012
Last updated: 4 Dec 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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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LacriFill Canalicular Occlusion for Dry Eye After LASIK
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All Dry Eye Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers
ClinicalTrials.gov ID: NCT01614600
Acronym / sponsor ID: A00849
Conditions: Dry Eye Syndrome, Myopia
Keywords: contact lens, dry eye syndrome, symptomatic, daily disposable, myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 8 Jun 2012 (estimated)
Results: Posted 4 Dec 2013

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
DAILIES® AquaComfort Plus®	Experimental	Device: Nelfilcon A contact lensesNelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks

Who may qualify

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

Key inclusion criteria (7 listed)

Currently wearing weekly/monthly, silicone hydrogel or traditional hydrogel soft contact lenses at least 8 hours per day and 5 days a week during the past 6 months.
Identified as symptomatic using a baseline screening questionnaire.
Requires vision correction in both eyes with a contact lens prescription as follows: sphere powers between -0.50 and -10.00 diopter (D) and cylinder powers </= 0.75D and no ADD correction.
Able to achieve visual acuity (VA) of at least 6/7.5 in each eye with study lenses in the available parameters.
Willing to wear study lenses for at least 8 hours/day and at least 5 days/week and discard the lenses at the end of the day and replace lenses every day with a new fresh pair.

Key exclusion criteria (7 listed)

Neophytes and current wearers of daily disposable contact lenses.
Requires monovision correction.
Any systemic or ocular disease or disorder (refractive disorder allowed) complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
A history of ocular surgery/trauma within the last 6 months.
Unwilling to discontinue mechanical eyelid therapy or eyelid scrubs within 14 days of enrollment and continuing during the study.

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
Nelfilcon A contact lensesAlso: DAILIES® AquaComfort Plus®Commercially marketed hydrogel contact lenses for daily wear, daily disposable use	Device	DAILIES® AquaComfort Plus®

Primary outcome

Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2
Time frame: Baseline, Week 1, Week 2
Contact lens symptoms were evaluated using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects rated 8 common contact lens-related ocular surface dryness symptoms at Baseline, Week 1, and Week 2 using a 5-point scale (1=never or not at all intense, 5=constantly or very intense). A scoring algorithm was used to calculate a composite score for each visit for all symptoms (-6.5 to 10). A higher composite score would indicate more contact lens related dry eye and a lower score, less contact lens related dry eye.

Results and safety

Results posted to the registry on 4 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DAILIES® AquaComfort Plus®	88	84

Primary outcome: Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2

Time frame: Baseline, Week 1, Week 2. Mean (Standard Deviation). Unit: Units on a scale

Measure	DAILIES® AquaComfort Plus® n = 74
Change from Baseline at Week 1	-0.09 (1.24)
Change from Baseline at Week 2	-0.29 (1.06)

Population analysed: Per Protocol: All enrolled and dispensed participants, minus any major protocol deviators as determined by masked review.

Adverse events

Time frame: Adverse events were collected for the duration of the study (3 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DAILIES® AquaComfort Plus®	0 of 88 (0%)	0 of 88 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dry Eye Syndrome

Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
Not yet recruiting
LacriFill Canalicular Occlusion for Dry Eye After LASIK
Dry Eye Syndrome
Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Not yet recruitingEarly Phase 1
a Novel siRNA Eyedrops for DED Treatment
Dry Eye
Recruiting
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
Dry Eye Disease

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.

Jami Kern, MBA, PhD study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing Nelfilcon A contact lenses in people with Dry Eye Syndrome and Myopia, 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 7 inclusion and 7 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 4 Dec 2013. 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 4 Dec 2013). 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 Contact Lens-Related Dryness Symptoms at Week 1 and Week 2 (time frame: Baseline, Week 1, Week 2). 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 NCT01614600.

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 4 Dec 2013; AzTrials last refreshed its copy on 8 Nov 2026.