Refractive ErrorNCT02699684
Comparison of Lotrafilcon B Lenses With Different Packaging Solutions
A study testing Lotrafilcon B contact lenses with EOBO-41, Lotrafilcon B contact lenses and Hydrogen peroxide-based lens care solution in people with Refractive Error, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate AIR OPTIX® plus HYDRAGLYDE® (AOHG) contact lenses compared to AIR OPTIX® AQUA (AOA) contact lenses in overall lens fit. 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?
- Lotrafilcon B contact lenses with EOBO-41, Lotrafilcon B contact lenses and Hydrogen peroxide-based lens care solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 12 May 2016to 20 Oct 2016
- 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 Informed Consent Document;
- Manifest cylinder less than or equal to 0.75 Diopter (D) in each eye;
- Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of AOA contact lenses within the protocol-specified power range;
- Willing to answer text messages on a daily basis during the study;
- Willing to discontinue artificial tears and rewetting drops on the days of study visits;
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week);
- Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current);
- History of herpetic keratitis, corneal surgery or irregular cornea;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
- Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- Pregnant or lactating;
- Participation in any clinical study within 30 days of Visit 1;
- Other protocol-specified exclusion criteria may apply.
About this study
Official title: One Month Clinical Comparison of Two Lotrafilcon B Spherical Lenses With Different Packaging Solutions
The purpose of this study is to evaluate AIR OPTIX® plus HYDRAGLYDE® (AOHG) contact lenses compared to AIR OPTIX® AQUA (AOA) contact lenses in overall lens fit.
Read the detailed description
Subjects must not wear any contact lenses prior to the visit on Day 1 (Insertion) for Period 1 or Day 1 (Insertion) for Period 2.
- Conditions
- Refractive Error
- Being tested
- Lotrafilcon B contact lenses with EOBO-41, Lotrafilcon B contact lenses, Hydrogen peroxide-based lens care solution, Saline solution for rinsing contact lenses, Saline solution for rinsing contact lens case
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lotrafilcon B contact lenses with EOBO-41Device
Also called AIR OPTIX® plus HYDRAGLYDE®, AOHG
Lotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41
Lotrafilcon B contact lensesDevice
Also called AIR OPTIX® AQUA, AOA
Lotrafilcon B contact lenses packaged with copolymer 845
Hydrogen peroxide-based lens care solutionDevice
Also called AOSEPT® PLUS, CLEAR CARE® PLUS
Commercially-available hydrogen peroxide-based lens care solution for cleaning, disinfecting, and storing silicone hydrogel soft contact lenses
Saline solution for rinsing contact lensesDevice
Also called Minims®
Commercially-available saline solution used as needed
Saline solution for rinsing contact lens caseDevice
Also called LENS PLUS® OCUPURE™
Commercially-available solution used as needed
| Study group | Role | What they receive |
|---|---|---|
| AOHG, then AOA | Other | Lotrafilcon B contact lenses with EOBO-41 worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution. Receives: Device: Lotrafilcon B contact lenses with EOBO-41; Device: Lotrafilcon B contact lenses; Device: Hydrogen peroxide-based lens care solution; Device: Saline solution for rinsing contact lenses; Device: Saline solution for rinsing contact lens case |
| AOA, then AOHG | Other | Lotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with EOBO-41 worn second. Both products worn bilaterally for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution. Receives: Device: Lotrafilcon B contact lenses with EOBO-41; Device: Lotrafilcon B contact lenses; Device: Hydrogen peroxide-based lens care solution; Device: Saline solution for rinsing contact lenses; Device: Saline solution for rinsing contact lens case |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Satisfying the "no Re-fit" Criteria in Both Eyes
Overall lens fit was graded by the Investigator on a 5-point scale: -2 (unacceptably tight); -1 (acceptably tight); 0 (optimal fit); +1 (acceptable loose); +2 (unacceptable loose). 'No re-fit' criteria was satisfied if an acceptable or optimal overall lens fit, that was also within one grade of the habitual lens fit value, was achieved.
Measured: Day 30, each product
Secondary outcomes (2)
Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear
The contact lens was removed from the eye. Cholesterol deposits were extracted and measured in micrograms (μg) per lens. Lower deposits indicate increased lens performance. Only one eye (right eye) contributed to the analysis.
Measured: Day 30, each product
Change From Insertion in Minimum Protected Area (MPA)
MPA (the minimum area of the contact lens surface (expressed in %) protected by the tear film between two natural blinks) was assessed by the Investigator during the interblink period using the Tearscope® lighting system. Higher values indicate a more stable tear film in front of the lens. This Outcome Measure was pre-specified for AOHG only. Both eyes contributed to the analysis.
Measured: Hour 0 (Lens Insertion) to Hour 12 on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study start12 May 2016
- Primary completion20 Oct 2016
- Study completion20 Oct 2016
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Manager, EMEA, Study director, Alcon, A Novartis Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699684
- Sponsor's protocol ID
- CLE270-P001
- Status last verified
- Aug 2017
- First submitted
- 1 Mar 2016
- Last updated
- 2 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Month Clinical Comparison of Two Lotrafilcon B Spherical Lenses With Different Packaging Solutions
- ClinicalTrials.gov ID
- NCT02699684
- Acronym / sponsor ID
- CLE270-P001
- Conditions
- Refractive Error
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 12 May 2016 (actual)
- Primary completion
- 20 Oct 2016 (actual)
- Study completion
- 20 Oct 2016 (actual)
- First posted
- 4 Mar 2016 (estimated)
- Results
- Posted 7 Sep 2017
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 evaluate AIR OPTIX® plus HYDRAGLYDE® (AOHG) contact lenses compared to AIR OPTIX® AQUA (AOA) contact lenses in overall lens fit.
Detailed description
Subjects must not wear any contact lenses prior to the visit on Day 1 (Insertion) for Period 1 or Day 1 (Insertion) for Period 2.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AOHG, then AOA | Other | Device: Lotrafilcon B contact lenses with EOBO-41, Device: Lotrafilcon B contact lenses, Device: Hydrogen peroxide-based lens care solution, Device: Saline solution for rinsing contact lenses, Device: Saline solution for rinsing contact lens caseLotrafilcon B contact lenses with EOBO-41 worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution. |
| AOA, then AOHG | Other | Device: Lotrafilcon B contact lenses with EOBO-41, Device: Lotrafilcon B contact lenses, Device: Hydrogen peroxide-based lens care solution, Device: Saline solution for rinsing contact lenses, Device: Saline solution for rinsing contact lens caseLotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with EOBO-41 worn second. Both products worn bilaterally for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must sign Informed Consent Document;
- Manifest cylinder less than or equal to 0.75 Diopter (D) in each eye;
- Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of AOA contact lenses within the protocol-specified power range;
- Willing to answer text messages on a daily basis during the study;
- Willing to discontinue artificial tears and rewetting drops on the days of study visits;
Key exclusion criteria (8 listed)
- Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week);
- Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current);
- History of herpetic keratitis, corneal surgery or irregular cornea;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
- Monocular (only 1 eye with functional vision) or fit with only 1 lens;
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 contact lenses with EOBO-41Also: AIR OPTIX® plus HYDRAGLYDE®, AOHGLotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41 | Device | AOA, then AOHG, AOHG, then AOA |
| Lotrafilcon B contact lensesAlso: AIR OPTIX® AQUA, AOALotrafilcon B contact lenses packaged with copolymer 845 | Device | AOA, then AOHG, AOHG, then AOA |
| Hydrogen peroxide-based lens care solutionAlso: AOSEPT® PLUS, CLEAR CARE® PLUSCommercially-available hydrogen peroxide-based lens care solution for cleaning, disinfecting, and storing silicone hydrogel soft contact lenses | Device | AOA, then AOHG, AOHG, then AOA |
| Saline solution for rinsing contact lensesAlso: Minims®Commercially-available saline solution used as needed | Device | AOA, then AOHG, AOHG, then AOA |
| Saline solution for rinsing contact lens caseAlso: LENS PLUS® OCUPURE™Commercially-available solution used as needed | Device | AOA, then AOHG, AOHG, then AOA |
Primary outcome
Percentage of Subjects Satisfying the "no Re-fit" Criteria in Both Eyes
Time frame: Day 30, each product
Overall lens fit was graded by the Investigator on a 5-point scale: -2 (unacceptably tight); -1 (acceptably tight); 0 (optimal fit); +1 (acceptable loose); +2 (unacceptable loose). 'No re-fit' criteria was satisfied if an acceptable or optimal overall lens fit, that was also within one grade of the habitual lens fit value, was achieved.
2 secondary outcomes
Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear
Time frame: Day 30, each product
Change From Insertion in Minimum Protected Area (MPA)
Time frame: Hour 0 (Lens Insertion) to Hour 12 on Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Refractive Error
Active, not recruiting
Correcting Myopia Among Secondary School Children to Increase Academic High School Attendance Rates in Rural Communities
Refractive Errors
Not yet recruiting
Consistency of an Automated Subjective Refraction Program Between Personnel With Diverse Professional Backgrounds and Senior Optometrists
Refractive Errors
Not yet recruiting
Evaluation of the Agreement Between Automated Program-Operated Phoropter Subjective Refraction and Optometrist-Performed Subjective Refraction
Refractive Errors
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Not yet recruiting
Dual-Action Lenses for Slowing Myopia in Children and Teens: A Randomized, Double-Blind Trial
Myopia, Refractive Errors
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, EMEA study director
Alcon, A Novartis Division
Questions about this trial
What is this clinical trial studying?
A study testing Lotrafilcon B contact lenses with EOBO-41, Lotrafilcon B contact lenses and Hydrogen peroxide-based lens care solution 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 6 inclusion and 8 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 2 Jul 2018. 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 7 Sep 2017). 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?
Percentage of Subjects Satisfying the "no Re-fit" Criteria in Both Eyes (time frame: Day 30, each product). 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 2 Jul 2018; AzTrials last refreshed its copy on 6 Nov 2026.