AstigmatismNCT00584831
Effect of Eye Movement on Toric Lens Orientation and Visual Acuity
A study testing senofilcon A, balafilcon A and omafilcon A in people with Astigmatism, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.
Trial summary
The relative performance of a new toric soft contact lens against toric contact lenses currently available in market, specifically for visual acuity and lens orientation. The study will be conducted in a staged approach (2 stages). Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Astigmatism
- What is being tested?
- senofilcon A, balafilcon A and omafilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2007to Feb 2008
- 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 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- They are aged between 18-39 years.
- They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They can attain at least 6/9 in each eye with their spectacle refraction.
- They have successfully worn contact lenses within six months of starting the study.
- They can be fitted with toric soft contact lenses to match the available power range.
Who cannot join
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops or ointment.
- They are aphakic.
- They have had corneal refractive surgery.
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
Show all 9Show fewer
- They are pregnant or lactating.
- They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
- They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience
Manchester, M60 1QD
About this study
Official title: Development and Implementation of a Clinical Test to Investigate the Change in Vision With Soft Toric Contact Lenses During Eye Movements
The relative performance of a new toric soft contact lens against toric contact lenses currently available in market, specifically for visual acuity and lens orientation. The study will be conducted in a staged approach (2 stages).
Read the detailed description
Non-dispensing, single-masked (subject-masked), randomised, controlled study. Two visits.
- Conditions
- Astigmatism
- Being tested
- senofilcon A, balafilcon A, omafilcon A, lotrafilcon B
- Keywords
- astigmatism, visual acuity, orientation, contact lenses
- Medical subject headings
- Astigmatism, Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
senofilcon ADevice
toric contact lens
balafilcon ADevice
toric contact lens
omafilcon ADevice
toric contact lens
lotrafilcon BDevice
toric contact lens
| Study group | Role | What they receive |
|---|---|---|
| Group 2 LSBO | Active comparator | contact lenses worn in this order: lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric Receives: Device: senofilcon A; Device: balafilcon A; Device: omafilcon A; Device: lotrafilcon B |
| Group 3 LOSB | Active comparator | contact lenses worn in this order: lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric Receives: Device: senofilcon A; Device: balafilcon A; Device: omafilcon A; Device: lotrafilcon B |
| Group 4 LBSO | Active comparator | contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric Receives: Device: senofilcon A; Device: balafilcon A; Device: omafilcon A; Device: lotrafilcon B |
| Group 5 LBOS | Active comparator | contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A Receives: Device: senofilcon A; Device: balafilcon A; Device: omafilcon A; Device: lotrafilcon B |
| Group 6 SLOB | Active comparator | contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, omafilcon A toric, balafilcon A toric Receives: Device: senofilcon A; Device: balafilcon A; Device: omafilcon A; Device: lotrafilcon B |
| Group 7 SLBO | Active comparator | contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric Receives: Device: senofilcon A; Device: balafilcon A; Device: omafilcon A; Device: lotrafilcon B |
| Group 8 SOLB | Active comparator | contact lenses worn in this order: senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric Receives: Device: senofilcon A; Device: balafilcon A; Device: omafilcon A; Device: lotrafilcon B |
| Group 9 SBLO | Active comparator | contact lenses worn in this order: senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric Receives: Device: senofilcon A; Device: balafilcon A; Device: omafilcon A; Device: lotrafilcon B |
| Group 10 SBOL | Active comparator | contact lenses worn in this order: senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric Receives: Device: senofilcon A; Device: balafilcon A; Device: omafilcon A; Device: lotrafilcon B |
| Group 11 OSLB | Active comparator | contact lenses worn in this order: omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric Receives: Device: senofilcon A; Device: balafilcon A; Device: omafilcon A; Device: lotrafilcon B |
| Group 12 OSBL | Active comparator | contact lenses worn in this order: omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric Receives: Device: senofilcon A; Device: balafilcon A; Device: omafilcon A; Device: lotrafilcon B |
| Group 13 OBLS | Active comparator | contact lenses worn in this order: omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric Receives: Device: senofilcon A; Device: balafilcon A; Device: omafilcon A; Device: lotrafilcon B |
| Group 14 OBSL | Active comparator | contact lenses worn in this order: omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric Receives: Device: senofilcon A; Device: balafilcon A; Device: omafilcon A; Device: lotrafilcon B |
| Group 15 BLSO | Active comparator | contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric Receives: Device: senofilcon A; Device: balafilcon A; Device: omafilcon A; Device: lotrafilcon B |
| Group 16 BLOS | Active comparator | contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric Receives: Device: senofilcon A; Device: balafilcon A; Device: omafilcon A; Device: lotrafilcon B |
| Group 17 BSOL | Active comparator | contact lenses worn in this order: balafilcon A toric, senofilcon A toric, omafilcon A toric, lotrafilcon B toric Receives: Device: senofilcon A; Device: balafilcon A; Device: omafilcon A; Device: lotrafilcon B |
| Group 18 BOLS | Active comparator | contact lenses worn in this order: balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric Receives: Device: senofilcon A; Device: balafilcon A; Device: omafilcon A; Device: lotrafilcon B |
| Group 19 BOSL | Active comparator | contact lenses worn in this order: balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric Receives: Device: senofilcon A; Device: balafilcon A; Device: omafilcon A; Device: lotrafilcon B |
| Group 1 LSOB | Active comparator | contact lenses worn in this order: lotrafilcon B toric/senofilcon A toric/omafilconA toric/balafilcon A toric Receives: Device: senofilcon A; Device: balafilcon A; Device: omafilcon A; Device: lotrafilcon B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity After Infero-temporal Version Movement.
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Measured: 10 minutes after insertion
Visual Acuity After Infero-nasal Version Movement.
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Measured: 10 minutes after lens insertion
Visual Acuity After Superior-temporal Version Movement
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Measured: 10 minutes after lens insertion
Visual Acuity After Superior-nasal Version Movement.
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Measured: 10 minutes after lens insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionFeb 2008
- Study completionFeb 2008
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
- Investigators
- Philip Morgan, PhD MCOptom, Principal investigator, Eurolens Research, The University of Manchester Dpt. of Optometry and Neuroscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584831
- Sponsor's protocol ID
- CR-0725
- Other IDs
- J07-416
- Status last verified
- May 2015
- First submitted
- 20 Dec 2007
- Last updated
- 21 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of a Clinical Test to Investigate the Change in Vision With Soft Toric Contact Lenses During Eye Movements
- ClinicalTrials.gov ID
- NCT00584831
- Acronym / sponsor ID
- CR-0725
- Conditions
- Astigmatism
- Keywords
- astigmatism, visual acuity, orientation, contact lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Manchester
- Study start
- Oct 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 2 Jan 2008 (estimated)
- Results
- Posted 1 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The relative performance of a new toric soft contact lens against toric contact lenses currently available in market, specifically for visual acuity and lens orientation. The study will be conducted in a staged approach (2 stages).
Detailed description
Non-dispensing, single-masked (subject-masked), randomised, controlled study. Two visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 19
| Arm | Type | Receives |
|---|---|---|
| Group 2 LSBO | Active comparator | Device: senofilcon A, Device: balafilcon A, Device: omafilcon A, Device: lotrafilcon Bcontact lenses worn in this order: lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric |
| Group 3 LOSB | Active comparator | Device: senofilcon A, Device: balafilcon A, Device: omafilcon A, Device: lotrafilcon Bcontact lenses worn in this order: lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric |
| Group 4 LBSO | Active comparator | Device: senofilcon A, Device: balafilcon A, Device: omafilcon A, Device: lotrafilcon Bcontact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric |
| Group 5 LBOS | Active comparator | Device: senofilcon A, Device: balafilcon A, Device: omafilcon A, Device: lotrafilcon Bcontact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A |
| Group 6 SLOB | Active comparator | Device: senofilcon A, Device: balafilcon A, Device: omafilcon A, Device: lotrafilcon Bcontact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, omafilcon A toric, balafilcon A toric |
| Group 7 SLBO | Active comparator | Device: senofilcon A, Device: balafilcon A, Device: omafilcon A, Device: lotrafilcon Bcontact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric |
| Group 8 SOLB | Active comparator | Device: senofilcon A, Device: balafilcon A, Device: omafilcon A, Device: lotrafilcon Bcontact lenses worn in this order: senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric |
| Group 9 SBLO | Active comparator | Device: senofilcon A, Device: balafilcon A, Device: omafilcon A, Device: lotrafilcon Bcontact lenses worn in this order: senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric |
| Group 10 SBOL | Active comparator | Device: senofilcon A, Device: balafilcon A, Device: omafilcon A, Device: lotrafilcon Bcontact lenses worn in this order: senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric |
| Group 11 OSLB | Active comparator | Device: senofilcon A, Device: balafilcon A, Device: omafilcon A, Device: lotrafilcon Bcontact lenses worn in this order: omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric |
| Group 12 OSBL | Active comparator | Device: senofilcon A, Device: balafilcon A, Device: omafilcon A, Device: lotrafilcon Bcontact lenses worn in this order: omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric |
| Group 13 OBLS | Active comparator | Device: senofilcon A, Device: balafilcon A, Device: omafilcon A, Device: lotrafilcon Bcontact lenses worn in this order: omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric |
| Group 14 OBSL | Active comparator | Device: senofilcon A, Device: balafilcon A, Device: omafilcon A, Device: lotrafilcon Bcontact lenses worn in this order: omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric |
| Group 15 BLSO | Active comparator | Device: senofilcon A, Device: balafilcon A, Device: omafilcon A, Device: lotrafilcon Bcontact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric |
| Group 16 BLOS | Active comparator | Device: senofilcon A, Device: balafilcon A, Device: omafilcon A, Device: lotrafilcon Bcontact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric |
| Group 17 BSOL | Active comparator | Device: senofilcon A, Device: balafilcon A, Device: omafilcon A, Device: lotrafilcon Bcontact lenses worn in this order: balafilcon A toric, senofilcon A toric, omafilcon A toric, lotrafilcon B toric |
| Group 18 BOLS | Active comparator | Device: senofilcon A, Device: balafilcon A, Device: omafilcon A, Device: lotrafilcon Bcontact lenses worn in this order: balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric |
| Group 19 BOSL | Active comparator | Device: senofilcon A, Device: balafilcon A, Device: omafilcon A, Device: lotrafilcon Bcontact lenses worn in this order: balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric |
| Group 1 LSOB | Active comparator | Device: senofilcon A, Device: balafilcon A, Device: omafilcon A, Device: lotrafilcon Bcontact lenses worn in this order: lotrafilcon B toric/senofilcon A toric/omafilconA toric/balafilcon A toric |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- They are aged between 18-39 years.
- They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They can attain at least 6/9 in each eye with their spectacle refraction.
- They have successfully worn contact lenses within six months of starting the study.
Key exclusion criteria (9 listed)
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops or ointment.
- They are aphakic.
- They have had corneal refractive surgery.
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 |
|---|---|---|
| senofilcon Atoric contact lens | Device | Group 1 LSOB, Group 10 SBOL, Group 11 OSLB, Group 12 OSBL, Group 13 OBLS, Group 14 OBSL, Group 15 BLSO, Group 16 BLOS, Group 17 BSOL, Group 18 BOLS, Group 19 BOSL, Group 2 LSBO, Group 3 LOSB, Group 4 LBSO, Group 5 LBOS, Group 6 SLOB, Group 7 SLBO, Group 8 SOLB, Group 9 SBLO |
| balafilcon Atoric contact lens | Device | Group 1 LSOB, Group 10 SBOL, Group 11 OSLB, Group 12 OSBL, Group 13 OBLS, Group 14 OBSL, Group 15 BLSO, Group 16 BLOS, Group 17 BSOL, Group 18 BOLS, Group 19 BOSL, Group 2 LSBO, Group 3 LOSB, Group 4 LBSO, Group 5 LBOS, Group 6 SLOB, Group 7 SLBO, Group 8 SOLB, Group 9 SBLO |
| omafilcon Atoric contact lens | Device | Group 1 LSOB, Group 10 SBOL, Group 11 OSLB, Group 12 OSBL, Group 13 OBLS, Group 14 OBSL, Group 15 BLSO, Group 16 BLOS, Group 17 BSOL, Group 18 BOLS, Group 19 BOSL, Group 2 LSBO, Group 3 LOSB, Group 4 LBSO, Group 5 LBOS, Group 6 SLOB, Group 7 SLBO, Group 8 SOLB, Group 9 SBLO |
| lotrafilcon Btoric contact lens | Device | Group 1 LSOB, Group 10 SBOL, Group 11 OSLB, Group 12 OSBL, Group 13 OBLS, Group 14 OBSL, Group 15 BLSO, Group 16 BLOS, Group 17 BSOL, Group 18 BOLS, Group 19 BOSL, Group 2 LSBO, Group 3 LOSB, Group 4 LBSO, Group 5 LBOS, Group 6 SLOB, Group 7 SLBO, Group 8 SOLB, Group 9 SBLO |
Primary outcome
Visual Acuity After Infero-temporal Version Movement.
Time frame: 10 minutes after insertion
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Visual Acuity After Infero-nasal Version Movement.
Time frame: 10 minutes after lens insertion
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Visual Acuity After Superior-temporal Version Movement
Time frame: 10 minutes after lens insertion
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Visual Acuity After Superior-nasal Version Movement.
Time frame: 10 minutes after lens insertion
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
- 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.
Philip Morgan, PhD MCOptom principal investigator
Eurolens Research, The University of Manchester Dpt. of Optometry and Neuroscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing senofilcon A, balafilcon A and omafilcon A in people with Astigmatism, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.
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 6 inclusion and 9 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 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Nov 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?
Visual Acuity After Infero-temporal Version Movement. (time frame: 10 minutes after insertion). The study lists 4 primary outcomes in all. 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 21 May 2015.