MyopiaNCT01016132
Clinical Evaluation of a Silicone Hydrogel Lens
A study testing lotrafilcon A contact lens in people with Myopia, run by CIBA VISION.
Trial summary
The purpose of this study is to assess the performance of an investigational contact lens among contact lens wearers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myopia
- What is being tested?
- lotrafilcon A contact lens
- Type of treatment
- Medical device
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Dec 2009
- 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
- Currently wearing lotrafilcon A lenses in both eyes for a minimum of 5 days per week, 8 hours per day, for 3 months.
- Removes contact lenses daily or sleeps overnight in contact lenses (up to 30 consecutive nights) as prescribed by regular eye care practitioner.
- Able to achieve distance visual acuity of at least 20/40 in each eye with study lenses.
- Other protocol inclusion/exclusion criteria may apply.
Who cannot join
- Eye injury or surgery within 12 months prior to enrollment.
- Currently enrolled in any clinical trial.
- History of corneal refractive surgery.
- Other protocol inclusion/exclusion criteria may apply.
About this study
The purpose of this study is to assess the performance of an investigational contact lens among contact lens wearers.
- Conditions
- Myopia
- Being tested
- lotrafilcon A 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 A contact lensDevice
Investigational silicone hydrogel, single-vision, soft contact lens worn for four weeks at least as often as and on the same basis as participant's habitual lenses, as prescribed by participant's eye care practitioner -- ie., on a daily wear, flex wear, or extended wear basis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Preference
Overall preference when comparing study lenses to "habitual" lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of four weeks' wear time. Overall preference was measured on a 5-point Likert scale as follows: Strongly Prefer Study Lenses; Somewhat Prefer Study Lenses; No Preference; Somewhat Prefer "Habitual" Lenses; Strongly Prefer "Habitual" Lenses.
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 posted18 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2009
- Study completionDec 2009
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
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 152 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
- NCT01016132
- Sponsor's protocol ID
- P-019-C-055
- Status last verified
- Sep 2011
- First submitted
- 17 Nov 2009
- Last updated
- 29 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Silicone Hydrogel Lens
- ClinicalTrials.gov ID
- NCT01016132
- Acronym / sponsor ID
- P-019-C-055
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- CIBA VISIONIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 18 Nov 2009 (estimated)
- Results
- Posted 12 Jan 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 assess the performance of an investigational contact lens among contact lens wearers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Currently wearing lotrafilcon A lenses in both eyes for a minimum of 5 days per week, 8 hours per day, for 3 months.
- Removes contact lenses daily or sleeps overnight in contact lenses (up to 30 consecutive nights) as prescribed by regular eye care practitioner.
- Able to achieve distance visual acuity of at least 20/40 in each eye with study lenses.
- Other protocol inclusion/exclusion criteria may apply.
Key exclusion criteria (4 listed)
- Eye injury or surgery within 12 months prior to enrollment.
- Currently enrolled in any clinical trial.
- History of corneal refractive surgery.
- Other protocol inclusion/exclusion criteria may apply.
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 A contact lensInvestigational silicone hydrogel, single-vision, soft contact lens worn for four weeks at least as often as and on the same basis as participant's habitual lenses, as prescribed by participant's eye care practitioner -- ie., on a daily wear, flex wear, or extended wear basis. | Device | – |
Primary outcome
Overall Preference
Time frame: 4 weeks of wear
Overall preference when comparing study lenses to "habitual" lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of four weeks' wear time. Overall preference was measured on a 5-point Likert scale as follows: Strongly Prefer Study Lenses; Somewhat Prefer Study Lenses; No Preference; Somewhat Prefer "Habitual" Lenses; Strongly Prefer "Habitual" Lenses.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2012.
- 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.
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 A 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 4 inclusion and 4 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 29 Jun 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 12 Jan 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?
Overall Preference (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 29 Jun 2012.