MyopiaNCT01007916
Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population
A study testing Lotrafilcon B contact lens and Habitual contact lens in people with Myopia, run by CIBA VISION.
Trial summary
The purpose of this study is to compare the performance of commercially marketed contact lenses to habitual contact lenses in a selected segment of the contact lens wearing population. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myopia
- What is being tested?
- Lotrafilcon B contact lens and Habitual contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Jan 2010
- 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
- Habitual spherical soft contact lens wearer who wears a contact lens with a recommended replacement schedule of 2 weeks or monthly.
- Wears lenses at least 5 days per week and at least 12 hours per day.
- Removes contact lenses daily or, if prescribed by their regular eye care practitioner, sleeps overnight in contact lenses no more than 6 consecutive nights.
- Reports 2 or fewer common lens-related symptoms with current contact lenses with a frequency of "frequently" or "always".
- Able to achieve distance visual acuity of at least 20/40 in each eye at the dispense of each pair of study lenses.
- Has acceptable or optimal fit for each eye at the dispense of each pair of study lenses.
- Other protocol-defined inclusion/exclusion criteria may apply.
Who cannot join
- Eye injury or surgery within twelve weeks prior to enrollment.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in any clinical trial.
- Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
- Currently sleeping in contact lenses for more than 6 consecutive nights.
- Currently wearing daily disposable contact lenses and certain protocol-specified lens brands.
- Other protocol-defined inclusion/exclusion criteria may apply.
About this study
The purpose of this study is to compare the performance of commercially marketed contact lenses to habitual contact lenses in a selected segment of the contact lens wearing population.
- Conditions
- Myopia
- Being tested
- Lotrafilcon B contact lens, Habitual contact lens
- 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 lensDevice
Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of monthly.
Habitual contact lensDevice
Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.
| Study group | Role | What they receive |
|---|---|---|
| Lotrafilcon B / Habitual | Other | Lotrafilcon B contact lenses worn first, with habitual contact lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights. Receives: Device: Lotrafilcon B contact lens; Device: Habitual contact lens |
| Habitual / Lotrafilcon B | Other | Habitual contact lenses worn first, with lotrafilcon B lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights. Receives: Device: Lotrafilcon B contact lens; Device: Habitual contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort Upon Insertion
Comfort upon insertion, as interpreted by the participant, was recorded on a questionnaire by the participant using a 10-point scale, with 1 being poor and 10 being excellent. Comfort upon insertion was assessed as a single, retrospective evaluation of 4-weeks' wear time.
Measured: 4 weeks of wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2010
- Study completionJan 2010
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- CIBA VISION
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007916
- Sponsor's protocol ID
- P-336-C-016
- Status last verified
- Jan 2012
- First submitted
- 2 Nov 2009
- Last updated
- 10 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population
- ClinicalTrials.gov ID
- NCT01007916
- Acronym / sponsor ID
- P-336-C-016
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- CIBA VISIONIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 5 Nov 2009 (estimated)
- Results
- Posted 25 Feb 2011
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 compare the performance of commercially marketed contact lenses to habitual contact lenses in a selected segment of the contact lens wearing population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lotrafilcon B / Habitual | Other | Device: Lotrafilcon B contact lens, Device: Habitual contact lensLotrafilcon B contact lenses worn first, with habitual contact lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights. |
| Habitual / Lotrafilcon B | Other | Device: Lotrafilcon B contact lens, Device: Habitual contact lensHabitual contact lenses worn first, with lotrafilcon B lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Habitual spherical soft contact lens wearer who wears a contact lens with a recommended replacement schedule of 2 weeks or monthly.
- Wears lenses at least 5 days per week and at least 12 hours per day.
- Removes contact lenses daily or, if prescribed by their regular eye care practitioner, sleeps overnight in contact lenses no more than 6 consecutive nights.
- Reports 2 or fewer common lens-related symptoms with current contact lenses with a frequency of "frequently" or "always".
- Able to achieve distance visual acuity of at least 20/40 in each eye at the dispense of each pair of study lenses.
Key exclusion criteria (7 listed)
- Eye injury or surgery within twelve weeks prior to enrollment.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in any clinical trial.
- Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
- Currently sleeping in contact lenses for more than 6 consecutive nights.
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 lensCommercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of monthly. | Device | Habitual / Lotrafilcon B, Lotrafilcon B / Habitual |
| Habitual contact lensHabitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly. | Device | Habitual / Lotrafilcon B, Lotrafilcon B / Habitual |
Primary outcome
Comfort Upon Insertion
Time frame: 4 weeks of wear
Comfort upon insertion, as interpreted by the participant, was recorded on a questionnaire by the participant using a 10-point scale, with 1 being poor and 10 being excellent. Comfort upon insertion was assessed as a single, retrospective evaluation of 4-weeks' wear time.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lotrafilcon B contact lens and Habitual contact lens 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 7 inclusion and 7 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 10 Jul 2012. 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 25 Feb 2011). 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?
Comfort Upon Insertion (time frame: 4 weeks of wear). 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 10 Jul 2012.