Refractive ErrorNCT02066922
A Comparative Study of Two Daily Disposable Contact Lenses in Higher Myopia Subjects
A study testing Delefilcon A contact lens, Narafilcon A contact lens and Spectacles in people with Refractive Error and Myopia, run by Alcon Research.
Trial summary
The purpose of this study is to compare the change from baseline in central corneal curvature at one week, between 2 silicone hydrogel lenses, in higher myopic subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Error, Myopia
- What is being tested?
- Delefilcon A contact lens, Narafilcon A contact lens and Spectacles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to 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
- Sign Informed Consent document;
- Higher degree of myopia in both eyes, i.e. habitual contact lens power between -10.00 diopters (D) and -17.00D;
- Best corrected distance visual acuity greater than or equal to 20/30 in each eye (measured with either spectacle refraction or habitual contact lenses plus over refraction);
- Manifest astigmatism less than or equal to -1.00D;
- Soft contact lens wear in both eyes at least 5 days per week and at least 8 hours per day;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Pregnant or lactating;
- Eye injury or surgery within twelve weeks immediately prior to enrollment;
- Any ocular condition that contraindicates contact lens wear;
- History of herpetic keratitis;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, including any use of topical ocular medications that would require instillation during contact lens wear, except for approved lubricating drops;
- Clinical significant dry eye not responding to treatment;
Show all 11Show fewer
- Previous corneal or refractive surgery or irregular cornea;
- Requires reading glasses;
- Participation in a clinical trial (including contact lens or contact lens care product) within the previous 30 days;
- Wears habitual lenses in an extended wear modality (routinely sleeps in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment;
- Other protocol-defined exclusion criteria may apply.
About this study
The purpose of this study is to compare the change from baseline in central corneal curvature at one week, between 2 silicone hydrogel lenses, in higher myopic subjects.
Read the detailed description
Participants were expected to attend 4 office visits. Visit 1 was the Screening/Enrollment visit. At Visit 2 (Baseline Visit), participants were randomized and the study lenses were trial fit. At Visit 3 (Dispense Visit), participants received study lenses for approximately 1 week of wear. Visit 4 was the Exit visit. Expected duration of participation in the study was 3 weeks.
- Conditions
- Refractive Error, Myopia
- Being tested
- Delefilcon A contact lens, Narafilcon A contact lens, Spectacles
- Keywords
- Contact lenses, Nearsightedness, Corneal curvature, K-reading, High minus, Spectacle refraction
- 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.
Delefilcon A contact lensDevice
Also called DAILIES® TOTAL1®
Commercially available silicone hydrogel contact lens
Narafilcon A contact lensDevice
Also called 1-DAY ACUVUE TRUEYE™
Commercially available silicone hydrogel contact lens
SpectaclesDevice
Incremental prescription worn over contact lenses if needed to provide acceptable vision
| Study group | Role | What they receive |
|---|---|---|
| DAILIES TOTAL1 | Experimental | Delefilcon A contact lens randomly assigned to one eye, with narafilcon A contact lens in the fellow eye for contralateral wear. Both products worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week, with spectacles worn over contact lenses if needed to provide acceptable vision. Receives: Device: Delefilcon A contact lens; Device: Narafilcon A contact lens; Device: Spectacles |
| TRUEYE | Active comparator | Narafilcon A contact lens randomly assigned to one eye, with delefilcon A contact lens in the fellow eye for contralateral wear. Both products worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week, with spectacles worn over contact lenses if needed to provide acceptable vision. Receives: Device: Delefilcon A contact lens; Device: Narafilcon A contact lens; Device: Spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average Central Corneal Curvature From Dispense at Week 1
Corneal curvature (horizontal and vertical keratometry values on the same eye) was measured using a calibrated keratometer prior to study lens dispense (Day 1) and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Minus values in change-from-baseline indicate corneal flattening.
Measured: Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear)
Secondary outcomes (1)
Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1
Subjective manifest refraction was assessed using a phoropter or trial frame set with the subject's current prescription at Baseline (Visit 2) after a 2-day washout period and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Spectacle over-refraction, if required, was performed. Higher myopia is indicated by larger negative values in manifest refraction.
Measured: Baseline, Week 1 (Day 8 of lens wear)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startMar 2014
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 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
- NCT02066922
- Sponsor's protocol ID
- C-12-057
- Status last verified
- May 2015
- First submitted
- 8 Aug 2013
- Last updated
- 8 Jun 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 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Two Daily Disposable Contact Lenses in Higher Myopia Subjects
- ClinicalTrials.gov ID
- NCT02066922
- Acronym / sponsor ID
- C-12-057
- Conditions
- Refractive Error, Myopia
- Keywords
- Contact lenses, Nearsightedness, Corneal curvature, K-reading, High minus, Spectacle refraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 20 Feb 2014 (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 compare the change from baseline in central corneal curvature at one week, between 2 silicone hydrogel lenses, in higher myopic subjects.
Detailed description
Participants were expected to attend 4 office visits. Visit 1 was the Screening/Enrollment visit. At Visit 2 (Baseline Visit), participants were randomized and the study lenses were trial fit. At Visit 3 (Dispense Visit), participants received study lenses for approximately 1 week of wear. Visit 4 was the Exit visit. Expected duration of participation in the study was 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAILIES TOTAL1 | Experimental | Device: Delefilcon A contact lens, Device: Narafilcon A contact lens, Device: SpectaclesDelefilcon A contact lens randomly assigned to one eye, with narafilcon A contact lens in the fellow eye for contralateral wear. Both products worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week, with spectacles worn over contact lenses if needed to provide acceptable vision. |
| TRUEYE | Active comparator | Device: Delefilcon A contact lens, Device: Narafilcon A contact lens, Device: SpectaclesNarafilcon A contact lens randomly assigned to one eye, with delefilcon A contact lens in the fellow eye for contralateral wear. Both products worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week, with spectacles worn over contact lenses if needed to provide acceptable vision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Sign Informed Consent document;
- Higher degree of myopia in both eyes, i.e. habitual contact lens power between -10.00 diopters (D) and -17.00D;
- Best corrected distance visual acuity greater than or equal to 20/30 in each eye (measured with either spectacle refraction or habitual contact lenses plus over refraction);
- Manifest astigmatism less than or equal to -1.00D;
- Soft contact lens wear in both eyes at least 5 days per week and at least 8 hours per day;
Key exclusion criteria (11 listed)
- Pregnant or lactating;
- Eye injury or surgery within twelve weeks immediately prior to enrollment;
- Any ocular condition that contraindicates contact lens wear;
- History of herpetic keratitis;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, including any use of topical ocular medications that would require instillation during contact lens wear, except for approved lubricating drops;
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 lensAlso: DAILIES® TOTAL1®Commercially available silicone hydrogel contact lens | Device | DAILIES TOTAL1, TRUEYE |
| Narafilcon A contact lensAlso: 1-DAY ACUVUE TRUEYE™Commercially available silicone hydrogel contact lens | Device | DAILIES TOTAL1, TRUEYE |
| SpectaclesIncremental prescription worn over contact lenses if needed to provide acceptable vision | Device | DAILIES TOTAL1, TRUEYE |
Primary outcome
Change in Average Central Corneal Curvature From Dispense at Week 1
Time frame: Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear)
Corneal curvature (horizontal and vertical keratometry values on the same eye) was measured using a calibrated keratometer prior to study lens dispense (Day 1) and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Minus values in change-from-baseline indicate corneal flattening.
1 secondary outcome
Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1
Time frame: Baseline, Week 1 (Day 8 of lens wear)
Results and safety
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.
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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
Questions about this trial
What is this clinical trial studying?
A study testing Delefilcon A contact lens, Narafilcon A contact lens and Spectacles in people with Refractive Error 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 6 inclusion and 11 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?
Change in Average Central Corneal Curvature From Dispense at Week 1 (time frame: Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear)). 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 8 Jun 2015.