AstigmatismNCT01007812
Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US
A study testing Lotrafilcon B contact lens and Comfilcon A contact lens in people with Astigmatism, run by CIBA VISION.
Trial summary
The purpose of this trial is to compare the performance of two different contact lenses for contact lens wearers with astigmatism. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Astigmatism
- What is being tested?
- Lotrafilcon B 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
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Nov 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
- Have a current spectacle prescription, preferably within 6-9 months.
- Currently wearing toric soft contact lenses in both eyes with at least 1 month experience wearing current brand for daily wear.
- Be correctable to at least 20/40 distance visual acuity in each eye while wearing trial lenses in the parameters available for this trial.
- Have 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 immediately prior to enrollment for this trial.
- Currently enrolled in any Clinical Trial.
- Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
- Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
- Currently wearing soft toric contact lenses as extended wear.
- Currently wearing either of the products to be worn in the study.
- Other protocol-defined inclusion/exclusion criteria may apply.
About this study
The purpose of this trial is to compare the performance of two different contact lenses for contact lens wearers with astigmatism.
- Conditions
- Astigmatism
- Being tested
- Lotrafilcon B contact lens, Comfilcon A contact lens
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lotrafilcon B contact lensDevice
Silicone hydrogel, toric, soft contact lens
Comfilcon A contact lensDevice
Silicone hydrogel, toric, soft contact lens
| Study group | Role | What they receive |
|---|---|---|
| Lotrafilcon B / Comfilcon A | Other | Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week, followed by Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week. Receives: Device: Lotrafilcon B contact lens; Device: Comfilcon A contact lens |
| Comfilcon A / Lotrafilcon B | Other | Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week, followed by Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week. Receives: Device: Lotrafilcon B contact lens; Device: Comfilcon A contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Vision
Overall vision, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Measured: After 1 week of wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionNov 2009
- Study completionNov 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 AstigmatismStudies 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
- NCT01007812
- Sponsor's protocol ID
- P-242-C-032
- Status last verified
- Jan 2012
- First submitted
- 2 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 Comparison of Two Silicone Hydrogel Toric Lenses in the US
- ClinicalTrials.gov ID
- NCT01007812
- Acronym / sponsor ID
- P-242-C-032
- Conditions
- Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- CIBA VISIONIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 4 Nov 2009 (estimated)
- Results
- Posted 17 Nov 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 the performance of two different contact lenses for contact lens wearers with astigmatism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lotrafilcon B / Comfilcon A | Other | Device: Lotrafilcon B contact lens, Device: Comfilcon A contact lensLotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week, followed by Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week. |
| Comfilcon A / Lotrafilcon B | Other | Device: Lotrafilcon B contact lens, Device: Comfilcon A contact lensComfilcon A silicone hydrogel, toric, soft contact lenses worn for one week, followed by Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Have a current spectacle prescription, preferably within 6-9 months.
- Currently wearing toric soft contact lenses in both eyes with at least 1 month experience wearing current brand for daily wear.
- Be correctable to at least 20/40 distance visual acuity in each eye while wearing trial lenses in the parameters available for this trial.
- Have acceptable or optimal fit for each eye at the dispense of each pair of study lenses.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key exclusion criteria (7 listed)
- Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
- Currently enrolled in any Clinical Trial.
- Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
- Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
- Currently wearing soft toric contact lenses as extended wear.
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 lensSilicone hydrogel, toric, soft contact lens | Device | Comfilcon A / Lotrafilcon B, Lotrafilcon B / Comfilcon A |
| Comfilcon A contact lensSilicone hydrogel, toric, soft contact lens | Device | Comfilcon A / Lotrafilcon B, Lotrafilcon B / Comfilcon A |
Primary outcome
Overall Vision
Time frame: After 1 week of wear
Overall vision, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of one week's wear time. Overall vision was 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 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 B contact lens and Comfilcon A contact lens in people with Astigmatism, 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 5 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 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 17 Nov 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?
Overall Vision (time frame: After 1 week 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.