MyopiaNCT00810511
Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period
A study testing Lotrafilcon A contact lens and Comfilcon A contact lens in people with Myopia, run by CIBA VISION.
Trial summary
The purpose of this trial is to compare two different contact lenses during 4 weeks of wear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Lotrafilcon A contact lens and Comfilcon A contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current soft contact lens wearer who wear their habitual lenses for no less than 10 hours a day, 5 days a week
- Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye while wearing trial lenses
- Replace lenses on a weekly or longer schedule
- Other protocol inclusion/exclusion criteria may apply
Who cannot join
- Requires concurrent ocular medication
- Eye injury or surgery within twelve weeks immediately prior to enrollment
- Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions
- Current soft toric lens wearers
- Those who dispose of their soft lenses on a daily basis
- Current NIGHT \& DAY® or Biofinity® lens wearers
- Other protocol-defined inclusion/exclusion criteria may apply
About this study
The purpose of this trial is to compare two different contact lenses during 4 weeks of wear.
- Conditions
- Myopia
- Being tested
- Lotrafilcon A contact lens, Comfilcon 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
Silicone hydrogel contact lens
Comfilcon A contact lensDevice
Silicone hydrogel contact lens
| Study group | Role | What they receive |
|---|---|---|
| Lotrafilcon A | Experimental | Investigational, spherical, silicone hydrogel contact lenses Receives: Device: Lotrafilcon A contact lens |
| Comfilcon A | Active comparator | Commercially marketed, spherical, silicone hydrogel contact lenses Receives: Device: Comfilcon A contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort at End of Day
Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent.
Measured: After 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 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2009
- Study completionJan 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 213 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
- NCT00810511
- Sponsor's protocol ID
- P-335-C-007
- Status last verified
- Jan 2012
- First submitted
- 17 Dec 2008
- Last updated
- 5 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period
- ClinicalTrials.gov ID
- NCT00810511
- Acronym / sponsor ID
- P-335-C-007
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- CIBA VISIONIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 18 Dec 2008 (estimated)
- Results
- Posted 1 Oct 2010
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 trial is to compare two different contact lenses during 4 weeks of wear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lotrafilcon A | Experimental | Device: Lotrafilcon A contact lensInvestigational, spherical, silicone hydrogel contact lenses |
| Comfilcon A | Active comparator | Device: Comfilcon A contact lensCommercially marketed, spherical, silicone hydrogel contact lenses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current soft contact lens wearer who wear their habitual lenses for no less than 10 hours a day, 5 days a week
- Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye while wearing trial lenses
- Replace lenses on a weekly or longer schedule
- Other protocol inclusion/exclusion criteria may apply
Key exclusion criteria (7 listed)
- Requires concurrent ocular medication
- Eye injury or surgery within twelve weeks immediately prior to enrollment
- Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions
- Current soft toric lens wearers
- Those who dispose of their soft lenses on a daily basis
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 lensSilicone hydrogel contact lens | Device | Lotrafilcon A |
| Comfilcon A contact lensSilicone hydrogel contact lens | Device | Comfilcon A |
Primary outcome
Comfort at End of Day
Time frame: After 4 weeks of wear
Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- 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 and Comfilcon 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 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 5 Dec 2023. 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 1 Oct 2010). 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 at End of Day (time frame: After 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 5 Dec 2023.