MyopiaNCT01635920
A Comparison of Silicone Hydrogel Contact Lenses: AIR OPTIX® COLORS Versus AIR OPTIX® AQUA
A study testing Lotrafilcon B contact lens with color and Lotrafilcon B contact lens in people with Myopia, run by Alcon Research.
Trial summary
The purpose of this study was to compare the overall fit of AIR OPTIX® COLORS to AIR OPTIX® AQUA contact lenses. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Lotrafilcon B contact lens with color and Lotrafilcon B contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Aug 2012
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Visual acuity of at least 20/30 (Snellen) in each eye at distance with contact lenses and best corrected visual acuity ≥ 20/25 in each eye.
- Manifest cylinder less than or equal to 0.75 diopter (D) (within the previous year) in each eye.
- Successful wear of AIR OPTIX® AQUA soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
- Willing to sign an Informed Consent form. If under legal age of consent, legally authorized representative must also sign an Informed Consent form.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of this study.
- Wears habitual lenses in an extended wear modality (sleeping in lenses overnight / not removing lenses on a daily basis).
- Monovision, monocular (only one eye with functional vision), or fit with only one lens.
- History of intolerance or hypersensitivity to any component of the test articles.
- Use of any over-the-counter (OTC) or prescribed topical ocular medications within previous 7 days (excluding rewetting drops).
- Moderate or severe corneal edema, corneal vascularization, corneal staining, injection, tarsal abnormalities, "other" complications, and any corneal infiltrates.
Show all 12Show fewer
- Current or history of ocular infection, severe inflammation, or disease within previous 6 months.
- Any systemic disease that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions.
- Ocular or intra-ocular surgery within the previous 12 months (excluding placement of punctal plugs).
- Use of medications contributing to dry eye or ocular irritation unless on a stable dosing regimen for a minimum of 30 days prior to study entry and able to remain on stable regimen throughout the study.
- Participation in any investigational clinical study within previous 30 days.
- Other protocol-specified exclusion criteria may apply.
About this study
Official title: A Comparison of Silicone Hydrogel Lenses: Colored Versus Non-Colored
The purpose of this study was to compare the overall fit of AIR OPTIX® COLORS to AIR OPTIX® AQUA contact lenses.
Read the detailed description
Eligible participants were randomized at Visit 1 (Screening) to receive 1 of the 2 investigational products (1:1 assignment). Between Visit 1 and Visit 2, participants wore their habitual AIR OPTIX® AQUA lenses. Investigational products were dispensed at Visit 2 (Baseline), after which participants were asked to return for 2 additional visits: Visit 3 (Day 14) and Visit 4 (Day 28).
- Conditions
- Myopia
- Being tested
- Lotrafilcon B contact lens with color, Lotrafilcon B contact lens
- Keywords
- contact lenses, color 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 contact lens with colorDevice
Also called AIR OPTIX® COLORS
Silicone hydrogel contact lens with color
Lotrafilcon B contact lensDevice
Also called AIR OPTIX® AQUA
Silicone hydrogel contact lens
| Study group | Role | What they receive |
|---|---|---|
| AIR OPTIX® COLORS | Experimental | Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks. Receives: Device: Lotrafilcon B contact lens with color |
| AIR OPTIX® AQUA | Active comparator | Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks. Receives: Device: Lotrafilcon B contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Same Fit in Both Eyes
Lens fit was assessed by the investigator for each eye using a biomicroscope (slit lamp), which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. "Same fit" was defined as an eye that achieved an acceptable or optimal overall lens fit with the study lens, that was also within one grade of the value observed on the same eye with the habitual lens at the baseline visit.
Measured: Up to Day 28
Secondary outcomes (1)
Subjective Rating of Overall Comfort
Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
Measured: Up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 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.
- 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
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- 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
- NCT01635920
- Sponsor's protocol ID
- C-12-004
- Status last verified
- Feb 2014
- First submitted
- 5 Jul 2012
- Last updated
- 28 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Silicone Hydrogel Lenses: Colored Versus Non-Colored
- ClinicalTrials.gov ID
- NCT01635920
- Acronym / sponsor ID
- C-12-004
- Conditions
- Myopia
- Keywords
- contact lenses, color contact lenses, myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Posted 28 Mar 2014
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 was to compare the overall fit of AIR OPTIX® COLORS to AIR OPTIX® AQUA contact lenses.
Detailed description
Eligible participants were randomized at Visit 1 (Screening) to receive 1 of the 2 investigational products (1:1 assignment). Between Visit 1 and Visit 2, participants wore their habitual AIR OPTIX® AQUA lenses. Investigational products were dispensed at Visit 2 (Baseline), after which participants were asked to return for 2 additional visits: Visit 3 (Day 14) and Visit 4 (Day 28).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIR OPTIX® COLORS | Experimental | Device: Lotrafilcon B contact lens with colorLotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks. |
| AIR OPTIX® AQUA | Active comparator | Device: Lotrafilcon B contact lensLotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Visual acuity of at least 20/30 (Snellen) in each eye at distance with contact lenses and best corrected visual acuity ≥ 20/25 in each eye.
- Manifest cylinder less than or equal to 0.75 diopter (D) (within the previous year) in each eye.
- Successful wear of AIR OPTIX® AQUA soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
- Willing to sign an Informed Consent form. If under legal age of consent, legally authorized representative must also sign an Informed Consent form.
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (12 listed)
- Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of this study.
- Wears habitual lenses in an extended wear modality (sleeping in lenses overnight / not removing lenses on a daily basis).
- Monovision, monocular (only one eye with functional vision), or fit with only one lens.
- History of intolerance or hypersensitivity to any component of the test articles.
- Use of any over-the-counter (OTC) or prescribed topical ocular medications within previous 7 days (excluding rewetting 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 |
|---|---|---|
| Lotrafilcon B contact lens with colorAlso: AIR OPTIX® COLORSSilicone hydrogel contact lens with color | Device | AIR OPTIX® COLORS |
| Lotrafilcon B contact lensAlso: AIR OPTIX® AQUASilicone hydrogel contact lens | Device | AIR OPTIX® AQUA |
Primary outcome
Percentage of Subjects With Same Fit in Both Eyes
Time frame: Up to Day 28
Lens fit was assessed by the investigator for each eye using a biomicroscope (slit lamp), which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. "Same fit" was defined as an eye that achieved an acceptable or optimal overall lens fit with the study lens, that was also within one grade of the value observed on the same eye with the habitual lens at the baseline visit.
1 secondary outcome
Subjective Rating of Overall Comfort
Time frame: Up to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
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 and Lotrafilcon B contact lens 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 5 inclusion and 12 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 28 Mar 2014. 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 28 Mar 2014). 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 With Same Fit in Both Eyes (time frame: Up to Day 28). 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 28 Mar 2014.