Cosmetic AppearanceNCT01398787
Evaluation of the Cosmetic Performance of AIR OPTIX® COLORS
A study testing Lotrafilcon B contact lens with color and Phemfilcon A contact lens with color in people with Cosmetic Appearance, run by CIBA VISION.
Trial summary
The purpose of this study was to evaluate the cosmetic performance of AIR OPTIX® COLORS contact lenses compared to FRESHLOOK® COLORBLENDS contact lenses in habitual FRESHLOOK® COLORBLENDS contact lens wearers. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cosmetic Appearance
- What is being tested?
- Lotrafilcon B contact lens with color and Phemfilcon A contact lens with color
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Dec 2011
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Sign written Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
- Have spectacles that provide acceptable near vision to wear over study lenses as needed to evaluate cosmetics of the lenses.
- Habitually wear FRESHLOOK® COLORBLENDS lenses at least two days per week.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Eye injury or surgery within twelve weeks of enrollment in this trial.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in any clinical trial.
- Evidence of systematic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.
- Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: Cosmetic Validation (US): AIR OPTIX® COLORS Among Habitual Wearers of FRESHLOOK®
The purpose of this study was to evaluate the cosmetic performance of AIR OPTIX® COLORS contact lenses compared to FRESHLOOK® COLORBLENDS contact lenses in habitual FRESHLOOK® COLORBLENDS contact lens wearers.
Read the detailed description
In this non-dispensing trial, each participant wore 4 pairs of color contact lenses (gray, blue, green, hazel) sequentially for less than 10 minutes each in a contralateral fashion (test lens in one eye, control lens in the other eye). Randomization took place for each of the 4 pairs of lenses as to which eye (left or right) wore the test and which wore the control. Participants were selected based on eye color (dark vs light/medium). The primary analysis population (AP1) was pre-specified as participants of any eye color who habitually wore FRESHLOOK® COLORBLENDS lenses in one of the four colors tested in this trial. Pair 1 lenses were dispensed per the participant's habitual lens color.
- Conditions
- Cosmetic Appearance
- Being tested
- Lotrafilcon B contact lens with color, Phemfilcon A contact lens with color
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
Plano (-0.00 diopter) silicone hydrogel contact lens in 1 of 4 colors: gray, blue, green, pure hazel
Phemfilcon A contact lens with colorDevice
Also called FRESHLOOK® COLORBLENDS
Plano (-0.00 diopter) hydrogel contact lens in 1 of 4 colors: ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel
| Study group | Role | What they receive |
|---|---|---|
| AIR OPTIX® COLORS | Experimental | Lotrafilcon B contact lens with color randomly assigned to one eye, with phemfilcon A contact lens with color in the fellow eye for contralateral wear Receives: Device: Lotrafilcon B contact lens with color |
| FRESHLOOK® COLORBLENDS | Active comparator | Phemfilcon A contact lens with color randomly assigned to one eye, with lotrafilcon B contact lens with color in the fellow eye for contralateral wear Receives: Device: Phemfilcon A contact lens with color |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Preference
The participant compared Pair 1 study lenses on eye and indicated overall preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Overall preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).
Measured: Day 1, 2-10 minutes after lens insertion
Initial Comfort Preference
The participant compared the initial comfort (way it feels) of Pair 1 study lenses and indicated preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Initial comfort preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).
Measured: Day 1, 2 minutes after lens insertion
Appearance Preference
The participant compared the appearance (way it looks) of Pair 1 study lenses on eye and indicated preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Appearance preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).
Measured: Day 1, 2-10 minutes after lens insertion
Subjective Rating of Initial Comfort
The participant compared the initial comfort (way it feels) of Pair 1 study lenses and rated initial comfort using a 10-point scale (1=poor, 10=excellent). Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).
Measured: Day 1, 2 minutes after lens insertion
Percent Positive Responses: Cosmetic Appearance (Strongly Agree, Agree)
The participant compared the cosmetic appearance of Pair 1 study lenses on eye and answered 9 appearance-related questions using a 4-point Likert scale (strongly agree, agree, disagree, strongly disagree). The combined percentage of the top two responses (strongly agree, agree) is reported for each question. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).
Measured: Day 1, 2-10 minutes after lens insertion
Percent Positive Purchase Intent (Definitely Would Buy, Probably Would Buy)
The participant compared Pair 1 study lenses and indicated purchase intent by answering the following question, "Assuming these lenses were at a price you would expect to pay, how likely would you be to purchase these lenses?" using a 5-point Likert scale (definitely would buy, probably would buy, might or might not buy, probably would not buy, definitely would not buy). The combined percentage of the top two responses (definitely would buy, probably would buy) is reported. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).
Measured: Day 1, 2-10 minutes after lens insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionDec 2011
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 Cosmetic AppearanceStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 198 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
- NCT01398787
- Sponsor's protocol ID
- P-383-C-004
- Status last verified
- Feb 2014
- First submitted
- 19 Jul 2011
- 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
- Cosmetic Validation (US): AIR OPTIX® COLORS Among Habitual Wearers of FRESHLOOK®
- ClinicalTrials.gov ID
- NCT01398787
- Acronym / sponsor ID
- P-383-C-004
- Conditions
- Cosmetic Appearance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- CIBA VISIONIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Jul 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 cosmetic performance of AIR OPTIX® COLORS contact lenses compared to FRESHLOOK® COLORBLENDS contact lenses in habitual FRESHLOOK® COLORBLENDS contact lens wearers.
Detailed description
In this non-dispensing trial, each participant wore 4 pairs of color contact lenses (gray, blue, green, hazel) sequentially for less than 10 minutes each in a contralateral fashion (test lens in one eye, control lens in the other eye). Randomization took place for each of the 4 pairs of lenses as to which eye (left or right) wore the test and which wore the control. Participants were selected based on eye color (dark vs light/medium). The primary analysis population (AP1) was pre-specified as participants of any eye color who habitually wore FRESHLOOK® COLORBLENDS lenses in one of the four colors tested in this trial. Pair 1 lenses were dispensed per the participant's habitual lens color.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIR OPTIX® COLORS | Experimental | Device: Lotrafilcon B contact lens with colorLotrafilcon B contact lens with color randomly assigned to one eye, with phemfilcon A contact lens with color in the fellow eye for contralateral wear |
| FRESHLOOK® COLORBLENDS | Active comparator | Device: Phemfilcon A contact lens with colorPhemfilcon A contact lens with color randomly assigned to one eye, with lotrafilcon B contact lens with color in the fellow eye for contralateral wear |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Sign written Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
- Have spectacles that provide acceptable near vision to wear over study lenses as needed to evaluate cosmetics of the lenses.
- Habitually wear FRESHLOOK® COLORBLENDS lenses at least two days per week.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (6 listed)
- Eye injury or surgery within twelve weeks of enrollment in this trial.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in any clinical trial.
- Evidence of systematic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.
- Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
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® COLORSPlano (-0.00 diopter) silicone hydrogel contact lens in 1 of 4 colors: gray, blue, green, pure hazel | Device | AIR OPTIX® COLORS |
| Phemfilcon A contact lens with colorAlso: FRESHLOOK® COLORBLENDSPlano (-0.00 diopter) hydrogel contact lens in 1 of 4 colors: ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel | Device | FRESHLOOK® COLORBLENDS |
Primary outcome
Overall Preference
Time frame: Day 1, 2-10 minutes after lens insertion
The participant compared Pair 1 study lenses on eye and indicated overall preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Overall preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).
Initial Comfort Preference
Time frame: Day 1, 2 minutes after lens insertion
The participant compared the initial comfort (way it feels) of Pair 1 study lenses and indicated preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Initial comfort preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).
Appearance Preference
Time frame: Day 1, 2-10 minutes after lens insertion
The participant compared the appearance (way it looks) of Pair 1 study lenses on eye and indicated preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Appearance preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).
Subjective Rating of Initial Comfort
Time frame: Day 1, 2 minutes after lens insertion
The participant compared the initial comfort (way it feels) of Pair 1 study lenses and rated initial comfort using a 10-point scale (1=poor, 10=excellent). Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).
Percent Positive Responses: Cosmetic Appearance (Strongly Agree, Agree)
Time frame: Day 1, 2-10 minutes after lens insertion
The participant compared the cosmetic appearance of Pair 1 study lenses on eye and answered 9 appearance-related questions using a 4-point Likert scale (strongly agree, agree, disagree, strongly disagree). The combined percentage of the top two responses (strongly agree, agree) is reported for each question. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).
Percent Positive Purchase Intent (Definitely Would Buy, Probably Would Buy)
Time frame: Day 1, 2-10 minutes after lens insertion
The participant compared Pair 1 study lenses and indicated purchase intent by answering the following question, "Assuming these lenses were at a price you would expect to pay, how likely would you be to purchase these lenses?" using a 5-point Likert scale (definitely would buy, probably would buy, might or might not buy, probably would not buy, definitely would not buy). The combined percentage of the top two responses (definitely would buy, probably would buy) is reported. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).
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.
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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 and Phemfilcon A contact lens with color in people with Cosmetic Appearance, 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 4 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 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?
Overall Preference (time frame: Day 1, 2-10 minutes after lens insertion). The study lists 6 primary outcomes in all. 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.