MyopiaNCT01614678
A Comparison of Manufacturing Processes for AIR OPTIX® COLORS Contact Lens
A study testing Lotrafilcon B contact lens with color, automated and Lotrafilcon B contact lens with color, semi-automated in people with Myopia, run by CIBA VISION.
Trial summary
The purpose of this feasibility study was to compare AIR OPTIX® COLORS contact lenses manufactured using an automated process to AIR OPTIX® COLORS contact lenses manufactured using a semi-automatic process. 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 contact lens with color, automated and Lotrafilcon B contact lens with color, semi-automated
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Aug 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to sign a written Informed Consent form.
- Cylinder ≤ -0.75 diopter (D).
- Able to achieve visual acuity (VA) of at least 20/30 Snellen in each eye at distance with contact lenses (CLCVA) and best corrected visual acuity (BCVA) ≥ 20/25.
- Have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses.
- Successful daily wear of single-vision spherical soft contact lenses in both eyes during the past 3 months for a minimum of 8 hours/day, 5 days/week.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Eye injury or surgery within twelve weeks immediately prior to enrollment in this trial.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in an ophthalmic clinical trial.
- Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions, as determined by the investigator.
- Pathologically dry eye.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: AIR OPTIX® COLORS: Automated vs Semi-automated Manufacturing Processes
The purpose of this feasibility study was to compare AIR OPTIX® COLORS contact lenses manufactured using an automated process to AIR OPTIX® COLORS contact lenses manufactured using a semi-automatic process.
- Conditions
- Myopia
- Being tested
- Lotrafilcon B contact lens with color, automated, Lotrafilcon B contact lens with color, semi-automated
- Keywords
- 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 contact lens with color, automatedDevice
Also called AIR OPTIX® COLORS
Silicone hydrogel contact lens with color manufactured via an automated process
Lotrafilcon B contact lens with color, semi-automatedDevice
Also called AIR OPTIX® COLORS
Silicone hydrogel contact lens with color manufactured via a semi-automated process
| Study group | Role | What they receive |
|---|---|---|
| AIR OPTIX® COLORS Auto, then AIR OPTIX® COLORS Semi-auto | Other | Lotrafilcon B contact lens with color, automated, worn first, with Lotrafilcon B contact lens with color, semi-automated, worn second. Each product worn on a daily wear basis approximately 8 hours a day, 5 days a week, for 2 weeks. Receives: Device: Lotrafilcon B contact lens with color, automated; Device: Lotrafilcon B contact lens with color, semi-automated |
| AIR OPTIX® COLORS Semi-auto, then AIR OPTIX® COLORS Auto | Other | Lotrafilcon B contact lens with color, semi-automated, worn first, with Lotrafilcon B contact lens with color, automated, worn second. Each product worn on a daily wear basis approximately 8 hours a day, 5 days a week, for 2 weeks. Receives: Device: Lotrafilcon B contact lens with color, automated; Device: Lotrafilcon B contact lens with color, semi-automated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall satisfaction
The participant was asked, "Please rate your overall satisfaction based on your experience with the study lenses over the last 2 weeks. When considering your rating, please take into account comfort, vision, and handling, but disregard the appearance of the lenses." Overall satisfaction was rated on a scale of 1-10, with 1=Not at all satisfied, and 10=Completely satisfied.
Measured: Week 2
Secondary outcomes (4)
Overall lens fit
Overall lens fit was assessed by the investigator on a 5-point scale, with +2=Unacceptably loose, +1=Acceptably loose, 0=Optimal, -1=Acceptably tight, -2=Unacceptably tight.
Measured: Dispense (Day 0)
Overall lens fit
Overall lens fit was assessed by the investigator on a 5-point scale, with +2=Unacceptably loose, +1=Acceptably loose, 0=Optimal, -1=Acceptably tight, -2=Unacceptably tight.
Measured: Week 2
Contact Lens Corrected Visual Acuity (CLCVA)
CLCVA (corrected distance monocular visual measurement in normal illumination) was tested for each eye individually while wearing study lenses. Participant read a Snellen chart distant to the participant in normal lighting, with 20/20 Snellen acuity considered normal distance eyesight.
Measured: Dispense (Day 0)
Corrected distance monocular visual measurement in normal illumination reported as Contact Lens Corrected Visual Acuity (CLCVA)
As tested for each eye individually while wearing study lenses. Participant will read a Snellen chart distant to the participant in normal lighting, with 20/20 Snellen acuity considered normal distance eyesight.
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- CIBA VISION
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharon Holden Thomas, O.D., Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614678
- Sponsor's protocol ID
- P-383-C-005/C-12-026
- Other IDs
- C-12-026
- Status last verified
- Feb 2014
- First submitted
- 5 Jun 2012
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIR OPTIX® COLORS: Automated vs Semi-automated Manufacturing Processes
- ClinicalTrials.gov ID
- NCT01614678
- Acronym / sponsor ID
- P-383-C-005/C-12-026
- Conditions
- Myopia
- Keywords
- myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- CIBA VISIONIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 8 Jun 2012 (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 feasibility study was to compare AIR OPTIX® COLORS contact lenses manufactured using an automated process to AIR OPTIX® COLORS contact lenses manufactured using a semi-automatic process.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIR OPTIX® COLORS Auto, then AIR OPTIX® COLORS Semi-auto | Other | Device: Lotrafilcon B contact lens with color, automated, Device: Lotrafilcon B contact lens with color, semi-automatedLotrafilcon B contact lens with color, automated, worn first, with Lotrafilcon B contact lens with color, semi-automated, worn second. Each product worn on a daily wear basis approximately 8 hours a day, 5 days a week, for 2 weeks. |
| AIR OPTIX® COLORS Semi-auto, then AIR OPTIX® COLORS Auto | Other | Device: Lotrafilcon B contact lens with color, automated, Device: Lotrafilcon B contact lens with color, semi-automatedLotrafilcon B contact lens with color, semi-automated, worn first, with Lotrafilcon B contact lens with color, automated, worn second. Each product worn on a daily wear basis approximately 8 hours a day, 5 days a week, for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able and willing to sign a written Informed Consent form.
- Cylinder ≤ -0.75 diopter (D).
- Able to achieve visual acuity (VA) of at least 20/30 Snellen in each eye at distance with contact lenses (CLCVA) and best corrected visual acuity (BCVA) ≥ 20/25.
- Have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses.
- Successful daily wear of single-vision spherical soft contact lenses in both eyes during the past 3 months for a minimum of 8 hours/day, 5 days/week.
Key exclusion criteria (6 listed)
- Eye injury or surgery within twelve weeks immediately prior to enrollment in this trial.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in an ophthalmic clinical trial.
- Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions, as determined by the investigator.
- Pathologically dry eye.
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 lens with color, automatedAlso: AIR OPTIX® COLORSSilicone hydrogel contact lens with color manufactured via an automated process | Device | AIR OPTIX® COLORS Auto, then AIR OPTIX® COLORS Semi-auto, AIR OPTIX® COLORS Semi-auto, then AIR OPTIX® COLORS Auto |
| Lotrafilcon B contact lens with color, semi-automatedAlso: AIR OPTIX® COLORSSilicone hydrogel contact lens with color manufactured via a semi-automated process | Device | AIR OPTIX® COLORS Auto, then AIR OPTIX® COLORS Semi-auto, AIR OPTIX® COLORS Semi-auto, then AIR OPTIX® COLORS Auto |
Primary outcome
Overall satisfaction
Time frame: Week 2
The participant was asked, "Please rate your overall satisfaction based on your experience with the study lenses over the last 2 weeks. When considering your rating, please take into account comfort, vision, and handling, but disregard the appearance of the lenses." Overall satisfaction was rated on a scale of 1-10, with 1=Not at all satisfied, and 10=Completely satisfied.
4 secondary outcomes
Overall lens fit
Time frame: Dispense (Day 0)
Overall lens fit
Time frame: Week 2
Contact Lens Corrected Visual Acuity (CLCVA)
Time frame: Dispense (Day 0)
Corrected distance monocular visual measurement in normal illumination reported as Contact Lens Corrected Visual Acuity (CLCVA)
Time frame: Week 2
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 5 May 2017.
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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.
Sharon Holden Thomas, O.D. study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A study testing Lotrafilcon B contact lens with color, automated and Lotrafilcon B contact lens with color, semi-automated in people with Myopia, run by CIBA VISION.
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 6 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 5 May 2017. 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?
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?
Overall satisfaction (time frame: Week 2). 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 5 May 2017.