MyopiaNCT02157909
DW Evaluation of Lotrafilcon B Lenses in a Modified Design
A study testing Lotrafilcon B sphere modified design contact lenses and Lotrafilcon B sphere contact lenses in people with Myopia, run by Alcon Research.
Trial summary
The purpose of this study is to demonstrate that Lotrafilcon B AIR OPTIX® AQUA sphere modified design lenses are noninferior to Lotrafilcon B AIR OPTIX® AQUA in overall lens fit by comparing the percent of subjects satisfying the "no re-fit" criteria in each treatment group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Lotrafilcon B sphere modified design contact lenses and Lotrafilcon B sphere contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jul 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
- Must sign an Informed Consent Document;
- Myopic, wear AIR OPTIX® AQUA lenses in the range of -1.00 to -5.00 diopters (D) in both eyes, and willing to comply with the wearing schedule;
- Manifest cylinder less than or equal to 0.75 D;
- Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance;
- Able to achieve distance visual acuity of at least 20/40 in each eye with habitual and study lenses;
- Wearing spherical AIR OPTIX® AQUA lenses in both eyes for at least 3 months (at least 8 hours per day, at least 5 days per week), wearing the habitual lenses for a minimum of 4 hours prior to the baseline study visit, and achieving an acceptable or optimal fit at baseline visit with habitual lenses in both eyes;
- Other protocol-defined criteria may apply.
Who cannot join
- Current soft contact lens wearer who regularly sleeps in lenses (1 or more nights per week);
- Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment;
- 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;
- History of herpetic keratitis;
- History of corneal or refractive surgery or irregular cornea;
- A pathologically dry eye that precludes contact lens wear;
Show all 13Show fewer
- Monocular (only one eye with functional vision);
- Monovision correction;
- History of intolerance or hypersensitivity to any component of the test articles or associated materials;
- Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days;
- Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment;
- Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study;
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: Daily Wear (DW) Evaluation of Lotrafilcon B in a Modified Design
The purpose of this study is to demonstrate that Lotrafilcon B AIR OPTIX® AQUA sphere modified design lenses are noninferior to Lotrafilcon B AIR OPTIX® AQUA in overall lens fit by comparing the percent of subjects satisfying the "no re-fit" criteria in each treatment group.
- Conditions
- Myopia
- Being tested
- Lotrafilcon B sphere modified design contact lenses, Lotrafilcon B sphere contact lenses
- Keywords
- Lens fit, contact lenses, myopia
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lotrafilcon B sphere modified design contact lensesDevice
Lotrafilcon B sphere contact lensesDevice
Also called AIR OPTIX® AQUA sphere, AOA
| Study group | Role | What they receive |
|---|---|---|
| AOA Modified | Experimental | Lotrafilcon B sphere modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days. Receives: Device: Lotrafilcon B sphere modified design contact lenses |
| AOA | Active comparator | Lotrafilcon B sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days. Receives: Device: Lotrafilcon B sphere contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes
With the contact lens on eye, the investigator assessed the lens fit immediately post-blink and following lower lid margin push-up with the lower lid using a 5-point scale, where -2 = Unacceptably tight (reduced movement, unacceptable), -1 = Acceptably tight (reduced movement, acceptable), 0 = Optimal fit / movement, +1 = Acceptably loose (excessive movement, acceptable), and +2 = Unacceptably loose (excessive movement, unacceptable). To meet the definition of "no re-fit," an eye had to have an acceptable or optimal overall lens fit with the study lens, as well as be within 1 grade of the overall lens fit assessed with the habitual lens at baseline. Proportion of subjects is reported as a percentage.
Measured: Dispense (Day 0), Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2014
- Study completionJul 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 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Manager, Vision Care, GCRA, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157909
- Sponsor's protocol ID
- C-13-055
- Status last verified
- Jul 2015
- First submitted
- 4 Jun 2014
- Last updated
- 11 Aug 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 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Wear (DW) Evaluation of Lotrafilcon B in a Modified Design
- ClinicalTrials.gov ID
- NCT02157909
- Acronym / sponsor ID
- C-13-055
- Conditions
- Myopia
- Keywords
- Lens fit, contact lenses, myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Posted 11 Aug 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 demonstrate that Lotrafilcon B AIR OPTIX® AQUA sphere modified design lenses are noninferior to Lotrafilcon B AIR OPTIX® AQUA in overall lens fit by comparing the percent of subjects satisfying the "no re-fit" criteria in each treatment group.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AOA Modified | Experimental | Device: Lotrafilcon B sphere modified design contact lensesLotrafilcon B sphere modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days. |
| AOA | Active comparator | Device: Lotrafilcon B sphere contact lensesLotrafilcon B sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must sign an Informed Consent Document;
- Myopic, wear AIR OPTIX® AQUA lenses in the range of -1.00 to -5.00 diopters (D) in both eyes, and willing to comply with the wearing schedule;
- Manifest cylinder less than or equal to 0.75 D;
- Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance;
- Able to achieve distance visual acuity of at least 20/40 in each eye with habitual and study lenses;
Key exclusion criteria (13 listed)
- Current soft contact lens wearer who regularly sleeps in lenses (1 or more nights per week);
- Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment;
- 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;
- History of herpetic keratitis;
- History of corneal or refractive surgery or irregular cornea;
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 |
|---|---|---|
| Lotrafilcon B sphere modified design contact lenses | Device | AOA Modified |
| Lotrafilcon B sphere contact lensesAlso: AIR OPTIX® AQUA sphere, AOA | Device | AOA |
Primary outcome
Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes
Time frame: Dispense (Day 0), Week 1
With the contact lens on eye, the investigator assessed the lens fit immediately post-blink and following lower lid margin push-up with the lower lid using a 5-point scale, where -2 = Unacceptably tight (reduced movement, unacceptable), -1 = Acceptably tight (reduced movement, acceptable), 0 = Optimal fit / movement, +1 = Acceptably loose (excessive movement, acceptable), and +2 = Unacceptably loose (excessive movement, unacceptable). To meet the definition of "no re-fit," an eye had to have an acceptable or optimal overall lens fit with the study lens, as well as be within 1 grade of the overall lens fit assessed with the habitual lens at baseline. Proportion of subjects is reported as a percentage.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 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.
Clinical Trial Manager, Vision Care, GCRA study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A study testing Lotrafilcon B sphere modified design contact lenses and Lotrafilcon B sphere 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 13 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 11 Aug 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 11 Aug 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?
Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes (time frame: Dispense (Day 0), Week 1). 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 11 Aug 2015.