Refractive ErrorNCT02072980
DAILIES TOTAL1® Lubricity Post Wear
A study testing Delefilcon A contact lenses in people with Refractive Error, run by Alcon Research.
Trial summary
The primary objective of the study is to demonstrate that the lubricity of DAILIES TOTAL1® (DT1) lenses after 16 hours of wear is equivalent to the lubricity of unworn DT1 lenses. 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?
- Delefilcon A contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Apr 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
- Willing and able to sign Informed Consent document.
- Adapted, current soft contact lens wearer.
- Requires contact lens powers within the specified range of -0.50 diopters (D) to -10.00D.
- Cylinder between 0.00D and -1.00D (inclusive) in both eyes at Visit 1 manifest refraction.
- Vision correctable to 20/25 or better in each eye at distance with study lenses.
- Willing to wear study lenses at least 16 waking hours in one day and attend all study visits.
- Able to be successfully fitted with study lenses.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Any ocular infection, inflammation, abnormality or active disease that would contraindicate contact lens wear, as determined by the Investigator.
- Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
- Use of artificial tears and rewetting drops during the study.
- Monocular (only one eye with functional vision) or fit with only one lens.
- Any abnormal ocular condition observed during the Visit 1 slit lamp examination.
- History of herpetic keratitis, ocular surgery, or irregular cornea.
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- Pregnant.
- Participation in any clinical study within 30 days of Visit 1.
- Other protocol-specified exclusion criteria may apply.
About this study
Official title: Evaluation of the Lubricity of DAILIES TOTAL1® Contact Lenses After Wear
The primary objective of the study is to demonstrate that the lubricity of DAILIES TOTAL1® (DT1) lenses after 16 hours of wear is equivalent to the lubricity of unworn DT1 lenses.
Read the detailed description
In this study, participants wore study lenses for 2 specified time periods (16 hours and 15 minutes, treatment sequence randomized) following which lenses were collected for ex vivo lubricity analysis. The ex vivo lubricity analysis was evaluated under a separate non-clinical protocol.
- Conditions
- Refractive Error
- Being tested
- Delefilcon A contact lenses
- Keywords
- DT1, DAILIES TOTAL1®, Lubricity
- Medical subject headings
- Refractive Errors
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
| Study group | Role | What they receive |
|---|---|---|
| 16hrs/15mins | Other | Delefilcon A contact lenses worn bilaterally (in both eyes) for 16 waking hours (1 day) in Period 1, followed by 15 minutes in Period 2. A fresh pair of lenses was dispensed for Period 2. Receives: Device: Delefilcon A contact lenses |
| 15mins/16hrs | Other | Delefilcon A contact lenses worn bilaterally for 15 minutes in Period 1, followed by 16 waking hours (1 day) in Period 2. A fresh pair of lenses was dispensed for Period 2. Receives: Device: Delefilcon A contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn
Worn contact lenses were removed from the participant's eye. The CF was calculated and compared to the CF for unworn contact lenses. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.
Measured: Day 1 (for each period), 16 hours
Secondary outcomes (1)
Average Coefficient of Friction at 15 Minutes
Worn contact lenses were removed from the participant's eye and the CF was calculated. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.
Measured: Day 1 (for each period), 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2014
- Study completionApr 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.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa L. Zoota, MPH, CCRA, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072980
- Sponsor's protocol ID
- M-14-002
- Status last verified
- Apr 2015
- First submitted
- 24 Feb 2014
- Last updated
- 14 May 2015
- 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 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Lubricity of DAILIES TOTAL1® Contact Lenses After Wear
- ClinicalTrials.gov ID
- NCT02072980
- Acronym / sponsor ID
- M-14-002
- Conditions
- Refractive Error
- Keywords
- DT1, DAILIES TOTAL1®, Lubricity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 27 Feb 2014 (estimated)
- Results
- Posted 14 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to demonstrate that the lubricity of DAILIES TOTAL1® (DT1) lenses after 16 hours of wear is equivalent to the lubricity of unworn DT1 lenses.
Detailed description
In this study, participants wore study lenses for 2 specified time periods (16 hours and 15 minutes, treatment sequence randomized) following which lenses were collected for ex vivo lubricity analysis. The ex vivo lubricity analysis was evaluated under a separate non-clinical protocol.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 16hrs/15mins | Other | Device: Delefilcon A contact lensesDelefilcon A contact lenses worn bilaterally (in both eyes) for 16 waking hours (1 day) in Period 1, followed by 15 minutes in Period 2. A fresh pair of lenses was dispensed for Period 2. |
| 15mins/16hrs | Other | Device: Delefilcon A contact lensesDelefilcon A contact lenses worn bilaterally for 15 minutes in Period 1, followed by 16 waking hours (1 day) in Period 2. A fresh pair of lenses was dispensed for Period 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing and able to sign Informed Consent document.
- Adapted, current soft contact lens wearer.
- Requires contact lens powers within the specified range of -0.50 diopters (D) to -10.00D.
- Cylinder between 0.00D and -1.00D (inclusive) in both eyes at Visit 1 manifest refraction.
- Vision correctable to 20/25 or better in each eye at distance with study lenses.
Key exclusion criteria (9 listed)
- Any ocular infection, inflammation, abnormality or active disease that would contraindicate contact lens wear, as determined by the Investigator.
- Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
- Use of artificial tears and rewetting drops during the study.
- Monocular (only one eye with functional vision) or fit with only one lens.
- Any abnormal ocular condition observed during the Visit 1 slit lamp examination.
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 | Device | 15mins/16hrs, 16hrs/15mins |
Primary outcome
Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn
Time frame: Day 1 (for each period), 16 hours
Worn contact lenses were removed from the participant's eye. The CF was calculated and compared to the CF for unworn contact lenses. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.
1 secondary outcome
Average Coefficient of Friction at 15 Minutes
Time frame: Day 1 (for each period), 15 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
- 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.
Lisa L. Zoota, MPH, CCRA study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A study testing Delefilcon A 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 8 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 May 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 14 May 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?
Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn (time frame: Day 1 (for each period), 16 hours). 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 May 2015.