Refractive ErrorNCT01440322
AIR OPTIX® COLORS Registration Trial
A study testing Lotrafilcon B contact lens with color and Lotrafilcon B contact lens in people with Refractive Error, run by CIBA VISION.
Trial summary
The purpose of this study was to evaluate the subjective and objective performance and the physiological response to AIR OPTIX® COLORS soft contact lenses compared with AIR OPTIX® AQUA contact lenses in participants with normal eyes and prescription needs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Refractive Error
- 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
- 150 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
- Normal eyes and not using any ocular medications.
- Willing to wear visitint or gray-colored spherical contact lenses in both eyes within available power ranges.
- Manifest cylinder less than or equal to 0.75 diopter.
- Best spectacle corrected visual acuity greater than or equal to 20/25.
- Have current prescription glasses.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Anterior segment infection, inflammation, or abnormality.
- Any active anterior segment ocular or systemic disease that would contraindicate contact lens wear.
- Use of ocular or systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
- History of refractive surgery or irregular cornea.
- History of pathologically dry eye.
- Corneal vascularization greater than 1 millimeter of penetration.
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- History of herpetic keratitis.
- Eye injury within 12 weeks immediately prior to enrollment in this trial.
- Currently enrolled in any clinical trial or participation in any clinical trial within the previous 30 days.
- Other protocol-defined exclusion criteria may apply.
About this study
The purpose of this study was to evaluate the subjective and objective performance and the physiological response to AIR OPTIX® COLORS soft contact lenses compared with AIR OPTIX® AQUA contact lenses in participants with normal eyes and prescription needs.
Read the detailed description
This study consisted of 7 scheduled visits conducted over a 3-month period. Enrolled participants were randomized (2:1) to receive either AIR OPTIX® COLORS lenses in both eyes or AIR OPTIX® AQUA lenses in both eyes.
- Conditions
- Refractive Error
- Being tested
- Lotrafilcon B contact lens with color, Lotrafilcon B contact lens
- Keywords
- Myopia, Contact lenses
- 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.
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 lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months Receives: Device: Lotrafilcon B contact lens with color |
| AIR OPTIX® AQUA | Active comparator | Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months Receives: Device: Lotrafilcon B contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)
Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.
Measured: Up to Month 3
Secondary outcomes (8)
Subjective Rating of Overall Vision
Overall vision, 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 Month 3
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 Month 3
Subjective Rating of Overall Handling
Overall handling, as rated by the participant on a 10-point scale, with 1 being difficult and 10 being easy. The participant rated both eyes together by providing one single rating.
Measured: Up to Month 3
Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)
Lens fit, as assessed by the investigator for each eye individually. Lens fit was rated on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, -2=unacceptably tight. The combined percentage of lenses assessed as "optimal," "acceptably loose," or "acceptably tight" is reported. Lenses from both eyes contributed to the percentage.
Measured: Up to Month 3
Lens Centration (Centered, Slight Decentration)
Lens centration, as assessed by the investigator for each eye individually. Lens centration was rated on a 5-point scale: 0=centered, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.
Measured: Up to Month 3
Dry Areas/Non-Wetting (None, Very Slight)
Dry areas/non-wetting (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Dry areas/non-wetting was rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.
Measured: Up to Month 3
Front Surface Deposits (None, Very Slight)
Front surface deposits on the contact lens, as assessed by the investigator for each eye individually. Front surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.
Measured: Up to Month 3
Back Surface Deposits (None, Very Slight)
Back surface deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.
Measured: Up to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2012
- Study completionJan 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 Refractive ErrorStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- CIBA VISION
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharon Holden Thomas, OD, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440322
- Sponsor's protocol ID
- P-383-C-003 (C-11-032)
- Status last verified
- Apr 2014
- First submitted
- 22 Sep 2011
- Last updated
- 8 May 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 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIR OPTIX® COLORS Registration Trial
- ClinicalTrials.gov ID
- NCT01440322
- Acronym / sponsor ID
- P-383-C-003 (C-11-032)
- Conditions
- Refractive Error
- Keywords
- Myopia, Contact lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- CIBA VISIONIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Sep 2011 (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 evaluate the subjective and objective performance and the physiological response to AIR OPTIX® COLORS soft contact lenses compared with AIR OPTIX® AQUA contact lenses in participants with normal eyes and prescription needs.
Detailed description
This study consisted of 7 scheduled visits conducted over a 3-month period. Enrolled participants were randomized (2:1) to receive either AIR OPTIX® COLORS lenses in both eyes or AIR OPTIX® AQUA lenses in both eyes.
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 lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months |
| AIR OPTIX® AQUA | Active comparator | Device: Lotrafilcon B contact lensLotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
- Normal eyes and not using any ocular medications.
- Willing to wear visitint or gray-colored spherical contact lenses in both eyes within available power ranges.
- Manifest cylinder less than or equal to 0.75 diopter.
- Best spectacle corrected visual acuity greater than or equal to 20/25.
Key exclusion criteria (10 listed)
- Anterior segment infection, inflammation, or abnormality.
- Any active anterior segment ocular or systemic disease that would contraindicate contact lens wear.
- Use of ocular or systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
- History of refractive surgery or irregular cornea.
- History of 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 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
Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)
Time frame: Up to Month 3
Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.
8 secondary outcomes
Subjective Rating of Overall Vision
Time frame: Up to Month 3
Subjective Rating of Overall Comfort
Time frame: Up to Month 3
Subjective Rating of Overall Handling
Time frame: Up to Month 3
Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)
Time frame: Up to Month 3
Lens Centration (Centered, Slight Decentration)
Time frame: Up to Month 3
Dry Areas/Non-Wetting (None, Very Slight)
Time frame: Up to Month 3
Front Surface Deposits (None, Very Slight)
Time frame: Up to Month 3
Back Surface Deposits (None, Very Slight)
Time frame: Up to Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
- 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.
Sharon Holden Thomas, OD 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 Refractive Error, 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 7 inclusion and 10 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 May 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?
Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) (time frame: Up to Month 3). 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 May 2014.