Refractive ErrorNCT01917162
Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses (Study 2)
A study testing Nelfilcon A contact lens and UltraFilcon B contact lens in people with Refractive Error, run by Alcon Research at 1 site in United Kingdom.
Trial summary
The purpose of this study is to compare the subjective performance of two daily disposable contact lenses with respect to comfort and handling. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Refractive Error
- What is being tested?
- Nelfilcon A contact lens and UltraFilcon B contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adapted soft contact lens wearer;
- Spherical distance contact lens prescription between -1.00 and -6.00 diopter (inclusive);
- Spectacle cylinder ≤0.75 diopter in the least astigmatic eye, ≤1.00 diopter in the other;
- Correctable to 6/9 (20/30) in both eyes;
- Read, understand, and sign the informed consent;
- Willing to comply with the wear schedule;
- Willing to comply with the study visit schedule;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Any active corneal infection, injury or inflammation;
- Systemic or ocular allergies which might interfere with contact lens wear;
- Systemic or ocular disease which might interfere with contact lens wear;
- Strabismus or amblyopia;
- Corneal refractive surgery and any anterior segment surgery;
- Use of systemic/topical medication contraindicating contact lens wear;
Show all 9Show fewer
- Use of gas permeable contact lenses within 1 month preceding the study;
- Participation in any concurrent clinical trial or in the last 30 days;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses
The purpose of this study is to compare the subjective performance of two daily disposable contact lenses with respect to comfort and handling.
- Conditions
- Refractive Error
- Being tested
- Nelfilcon A contact lens, UltraFilcon B contact lens
- Keywords
- contact lenses, daily disposable contact lenses, silicone hydrogel, contact lens comfort, near-sighted
- Medical subject headings
- Refractive Errors, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nelfilcon A contact lensDevice
Also called DAILIES® AquaComfort Plus®
Soft contact lens CE-marked for daily disposable wear.
UltraFilcon B contact lensDevice
Also called Procornea BYO Air Daily
Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Private-label versions may be used.
| Study group | Role | What they receive |
|---|---|---|
| Nelfilcon A/UltraFilcon B | Other | Nelfilcon A contact lenses, followed by UltraFilcon B contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality. Receives: Device: Nelfilcon A contact lens; Device: UltraFilcon B contact lens |
| UltraFilcon B/Nelfilcon A | Other | UltraFilcon B contact lenses, followed by Nelfilcon A contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality. Receives: Device: Nelfilcon A contact lens; Device: UltraFilcon B contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial comfort
Initial Comfort (within 10-15 minutes of lens insertion) will be assessed bilaterally by the participant at time of dispense. Initial Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).
Measured: Baseline
Secondary outcomes (3)
End of Day Comfort
End of Day Comfort will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. End of Day Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).
Measured: Day 7
Overall Comfort
Overall Comfort will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. Overall Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).
Measured: Day 7
Overall Handling at Time of Removal
Overall Handling at Time of Removal will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. Overall Handling at Time of Removal will be graded on a 1-10 scale (10=excellent, very easy; 1=unmanageable).
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joachim Nick, Dipl. Ing., Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917162
- Sponsor's protocol ID
- C-13-033
- Status last verified
- Nov 2013
- First submitted
- 4 Aug 2013
- Last updated
- 7 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses
- ClinicalTrials.gov ID
- NCT01917162
- Acronym / sponsor ID
- C-13-033
- Conditions
- Refractive Error
- Keywords
- contact lenses, daily disposable contact lenses, silicone hydrogel, contact lens comfort, near-sighted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 6 Aug 2013 (estimated)
- Results
- Not posted in the source record
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 compare the subjective performance of two daily disposable contact lenses with respect to comfort and handling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nelfilcon A/UltraFilcon B | Other | Device: Nelfilcon A contact lens, Device: UltraFilcon B contact lensNelfilcon A contact lenses, followed by UltraFilcon B contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality. |
| UltraFilcon B/Nelfilcon A | Other | Device: Nelfilcon A contact lens, Device: UltraFilcon B contact lensUltraFilcon B contact lenses, followed by Nelfilcon A contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adapted soft contact lens wearer;
- Spherical distance contact lens prescription between -1.00 and -6.00 diopter (inclusive);
- Spectacle cylinder ≤0.75 diopter in the least astigmatic eye, ≤1.00 diopter in the other;
- Correctable to 6/9 (20/30) in both eyes;
- Read, understand, and sign the informed consent;
Key exclusion criteria (9 listed)
- Any active corneal infection, injury or inflammation;
- Systemic or ocular allergies which might interfere with contact lens wear;
- Systemic or ocular disease which might interfere with contact lens wear;
- Strabismus or amblyopia;
- Corneal refractive surgery and any anterior segment surgery;
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 lensAlso: DAILIES® AquaComfort Plus®Soft contact lens CE-marked for daily disposable wear. | Device | Nelfilcon A/UltraFilcon B, UltraFilcon B/Nelfilcon A |
| UltraFilcon B contact lensAlso: Procornea BYO Air DailySilicone hydrogel soft contact lens CE-marked for daily disposable wear. Private-label versions may be used. | Device | Nelfilcon A/UltraFilcon B, UltraFilcon B/Nelfilcon A |
Primary outcome
Initial comfort
Time frame: Baseline
Initial Comfort (within 10-15 minutes of lens insertion) will be assessed bilaterally by the participant at time of dispense. Initial Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).
3 secondary outcomes
End of Day Comfort
Time frame: Day 7
Overall Comfort
Time frame: Day 7
Overall Handling at Time of Removal
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2013.
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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.
Joachim Nick, Dipl. Ing. study director
Alcon Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nelfilcon A contact lens and UltraFilcon B contact lens in people with Refractive Error, run by Alcon Research at 1 site in United Kingdom.
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 7 Nov 2013. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Initial comfort (time frame: Baseline). 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 7 Nov 2013.