AstigmatismNCT01207466
Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism
A study testing Nelfilcon A investigational contact lens and Nelfilcon A commercial contact lens in people with Astigmatism and Myopia, run by CIBA VISION.
Trial summary
The purpose of this trial is to compare the performance of two 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, Myopia
- What is being tested?
- Nelfilcon A investigational contact lens and Nelfilcon A commercial contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Oct 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
- Currently wearing soft contact lenses with astigmatism correction
- Other protocol inclusion criteria may apply
Who cannot join
- Eye injury or surgery within twelve weeks prior to enrollment
- Currently enrolled in an ophthalmic clinical trial
- Strabismus
- Any use of medications for which contact lens wear could be contraindicated as determined by the investigator
- Other protocol exclusion criteria may apply
About this study
The purpose of this trial is to compare the performance of two contact lenses for contact lens wearers with astigmatism.
- Conditions
- Astigmatism, Myopia
- Being tested
- Nelfilcon A investigational contact lens, Nelfilcon A commercial contact lens
- Medical subject headings
- Astigmatism, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nelfilcon A investigational contact lensDevice
Investigational, soft contact lens for astigmatism worn on a daily disposable basis.
Nelfilcon A commercial contact lensDevice
Also called Focus DAILIES Toric
Commercially marketed, soft contact lens for astigmatism worn on a daily disposable basis.
| Study group | Role | What they receive |
|---|---|---|
| Nelfilcon A invest'l / nelfilconA comm'l | Other | Nelfilcon A investigational toric contact lenses worn first, with nelfilcon A commercial toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week. Receives: Device: Nelfilcon A investigational contact lens; Device: Nelfilcon A commercial contact lens |
| Nelfilcon A comm'l / nelfilconA invest'l | Other | Nelfilcon A commercial toric contact lenses worn first, with nelfilcon A investigational toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week. Receives: Device: Nelfilcon A investigational contact lens; Device: Nelfilcon A commercial contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Vision (Crisp and Clear)
Quality of vision (crisp and clear), as interpreted and reported by the participant by eye on a questionnaire as a single, retrospective evaluation of one week's wear time. Quality of vision was assessed on a 10-point scale, with 1 being poor and 10 being excellent.
Measured: 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 posted23 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2010
- Study completionOct 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 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
- 95 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
- NCT01207466
- Sponsor's protocol ID
- P-415-C-001 sub 2
- Status last verified
- Jan 2012
- First submitted
- 21 Sep 2010
- 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
- Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism
- ClinicalTrials.gov ID
- NCT01207466
- Acronym / sponsor ID
- P-415-C-001 sub 2
- Conditions
- Astigmatism, Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- CIBA VISIONIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 23 Sep 2010 (estimated)
- Results
- Posted 26 Aug 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 trial is to compare the performance of two 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 |
|---|---|---|
| Nelfilcon A invest'l / nelfilconA comm'l | Other | Device: Nelfilcon A investigational contact lens, Device: Nelfilcon A commercial contact lensNelfilcon A investigational toric contact lenses worn first, with nelfilcon A commercial toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week. |
| Nelfilcon A comm'l / nelfilconA invest'l | Other | Device: Nelfilcon A investigational contact lens, Device: Nelfilcon A commercial contact lensNelfilcon A commercial toric contact lenses worn first, with nelfilcon A investigational toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Currently wearing soft contact lenses with astigmatism correction
- Other protocol inclusion criteria may apply
Key exclusion criteria (5 listed)
- Eye injury or surgery within twelve weeks prior to enrollment
- Currently enrolled in an ophthalmic clinical trial
- Strabismus
- Any use of medications for which contact lens wear could be contraindicated as determined by the investigator
- Other protocol 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 |
|---|---|---|
| Nelfilcon A investigational contact lensInvestigational, soft contact lens for astigmatism worn on a daily disposable basis. | Device | Nelfilcon A comm'l / nelfilconA invest'l, Nelfilcon A invest'l / nelfilconA comm'l |
| Nelfilcon A commercial contact lensAlso: Focus DAILIES ToricCommercially marketed, soft contact lens for astigmatism worn on a daily disposable basis. | Device | Nelfilcon A comm'l / nelfilconA invest'l, Nelfilcon A invest'l / nelfilconA comm'l |
Primary outcome
Quality of Vision (Crisp and Clear)
Time frame: 1 week of wear
Quality of vision (crisp and clear), as interpreted and reported by the participant by eye on a questionnaire as a single, retrospective evaluation of one week's wear time. Quality of vision was assessed 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 10 Jul 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 Nelfilcon A investigational contact lens and Nelfilcon A commercial contact lens in people with Astigmatism and 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 2 inclusion and 5 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 26 Aug 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?
Quality of Vision (Crisp and Clear) (time frame: 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 10 Jul 2012.