MyopiaNCT01636986
A Prospective Study of Two Daily Disposable Contact Lenses
A study testing Delefilcon A contact lenses and Etafilcon A contact lenses in people with Myopia, run by Alcon Research.
Trial summary
The purpose of this study was to evaluate the performance of a novel silicone hydrogel contact lens, DAILIES TOTAL1® (DT1) compared to the standard hydrogel material in 1-DAY ACUVUE® MOIST® (1DAVM) contact lens in contact lens wearers identified as having contact lens-related dryness symptoms. Read more about this study
- Who is it for?
- Ages 18 to 43 years
- Conditions the study is for
- Myopia
- What is being tested?
- Delefilcon A contact lenses and Etafilcon A contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Nov 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 to 43 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be of legal age of consent and sign written Informed Consent Document and HIPAA form.
- Currently wearing soft contact lenses and identified as having contact lens-related dryness symptoms based upon responses to the Contact Lens Dry Eye Questionnaire.
- Wearing either daily disposable contact lenses or bi-weekly/monthly replacement contact lenses, daily wear use only (no extended wear use).
- Able to achieve distance visual acuity of at least 20/25 in each eye with study lenses in the available parameters, -0.50D to -6.00D.
- Willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
- Willing and able to follow instructions and maintain the appointment schedule.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Neophyte or current wearer of DAILIES TOTAL1® or 1-DAY ACUVUE® MOIST™ contact lenses.
- Requires monovision or presbyopic correction.
- Any systemic or ocular disease or disorder complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
- Recent (within 7 days of enrollment) or current ocular infection, active ocular inflammation, glaucoma or preauricular lymphadenopathy.
- Clinically significant lash or lid abnormality.
- Systemic disease that, in the investigator's best judgment, would prohibit or confound safe contact lens wear.
Show all 9Show fewer
- History of ocular surgery/trauma within the last 6 months.
- Topical or systemic antibiotics use within 7 days of enrollment.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: Impact of a Novel Silicone Hydrogel in Reducing Contact Lens-Related Dryness Symptoms in Existing Contact Lens Wearers
The purpose of this study was to evaluate the performance of a novel silicone hydrogel contact lens, DAILIES TOTAL1® (DT1) compared to the standard hydrogel material in 1-DAY ACUVUE® MOIST® (1DAVM) contact lens in contact lens wearers identified as having contact lens-related dryness symptoms.
Read the detailed description
Three study visits occurred over the course of 28 ± 3 days.
- Conditions
- Myopia
- Being tested
- Delefilcon A contact lenses, Etafilcon A contact lenses
- Keywords
- myopia, contact lenses, dry eyes, comfort, replacement
- 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.
Delefilcon A contact lensesDevice
Also called DAILIES TOTAL1®
Silicone hydrogel contact lenses for daily wear, daily disposable use
Etafilcon A contact lensesDevice
Also called 1-DAY ACUVUE® MOIST™
Hydrogel contact lenses for daily wear, daily disposable use
| Study group | Role | What they receive |
|---|---|---|
| DT1 | Experimental | Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks Receives: Device: Delefilcon A contact lenses |
| 1DAVM | Active comparator | Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks Receives: Device: Etafilcon 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 Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ
Contact lens symptoms were evaluated using the Contact Lens and Dry Eye Questionnaire (CLDEQ). The participant indicated the frequency with which 9 common contact lens-related ocular surface dryness symptoms were experienced over the previous week. Each symptom was rated on a 5-point scale (1=never, 5=constantly). Both eyes contributed to the mean. A more negative change number indicates a greater perceived improvement, namely, lessening of the symptom.
Measured: Day 0, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionNov 2012
- Study completionNov 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 MyopiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jami Kern, Ph.D., Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636986
- Sponsor's protocol ID
- A00930
- Status last verified
- Nov 2013
- First submitted
- 6 Jul 2012
- Last updated
- 14 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Novel Silicone Hydrogel in Reducing Contact Lens-Related Dryness Symptoms in Existing Contact Lens Wearers
- ClinicalTrials.gov ID
- NCT01636986
- Acronym / sponsor ID
- A00930
- Conditions
- Myopia
- Keywords
- myopia, contact lenses, dry eyes, comfort, replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Posted 14 Jan 2014
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 was to evaluate the performance of a novel silicone hydrogel contact lens, DAILIES TOTAL1® (DT1) compared to the standard hydrogel material in 1-DAY ACUVUE® MOIST® (1DAVM) contact lens in contact lens wearers identified as having contact lens-related dryness symptoms.
Detailed description
Three study visits occurred over the course of 28 ± 3 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DT1 | Experimental | Device: Delefilcon A contact lensesDelefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks |
| 1DAVM | Active comparator | Device: Etafilcon A contact lensesEtafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Be of legal age of consent and sign written Informed Consent Document and HIPAA form.
- Currently wearing soft contact lenses and identified as having contact lens-related dryness symptoms based upon responses to the Contact Lens Dry Eye Questionnaire.
- Wearing either daily disposable contact lenses or bi-weekly/monthly replacement contact lenses, daily wear use only (no extended wear use).
- Able to achieve distance visual acuity of at least 20/25 in each eye with study lenses in the available parameters, -0.50D to -6.00D.
- Willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
Key exclusion criteria (9 listed)
- Neophyte or current wearer of DAILIES TOTAL1® or 1-DAY ACUVUE® MOIST™ contact lenses.
- Requires monovision or presbyopic correction.
- Any systemic or ocular disease or disorder complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
- Recent (within 7 days of enrollment) or current ocular infection, active ocular inflammation, glaucoma or preauricular lymphadenopathy.
- Clinically significant lash or lid abnormality.
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 |
|---|---|---|
| Delefilcon A contact lensesAlso: DAILIES TOTAL1®Silicone hydrogel contact lenses for daily wear, daily disposable use | Device | DT1 |
| Etafilcon A contact lensesAlso: 1-DAY ACUVUE® MOIST™Hydrogel contact lenses for daily wear, daily disposable use | Device | 1DAVM |
Primary outcome
Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ
Time frame: Day 0, Week 4
Contact lens symptoms were evaluated using the Contact Lens and Dry Eye Questionnaire (CLDEQ). The participant indicated the frequency with which 9 common contact lens-related ocular surface dryness symptoms were experienced over the previous week. Each symptom was rated on a 5-point scale (1=never, 5=constantly). Both eyes contributed to the mean. A more negative change number indicates a greater perceived improvement, namely, lessening of the symptom.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
- 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.
Jami Kern, Ph.D. study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A study testing Delefilcon A contact lenses and Etafilcon A contact lenses in people with 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 9 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 14 Jan 2014. 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 14 Jan 2014). 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 Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ (time frame: Day 0, Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2014.