AstigmatismNCT01552876
Comparative Clinical Evaluation of Soft Toric Lens Designs
A study testing etafilcon A, nelfilcon A and Filcon II 3 in people with Astigmatism and Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.
Trial summary
This study is evaluating the initial fit of toric contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astigmatism, Myopia
- What is being tested?
- etafilcon A, nelfilcon A and Filcon II 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2012to Apr 2012
- 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
- Be greater than or equal to 18 years old.
- Read, understand, and sign written Statement of Informed Consent.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Be existing soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
- Require a visual correction in both eyes (monovision allowed but no monofit).
- Have a spherical contact lens requirement in the range -0.50D to -6.00D.
Show all 9Show fewer
- Have astigmatism of between -0.50 and -2.00DC in both eyes.
- Monocular distance visual acuity correctable to 6/9 (0.2 logMAR) or better in each eye with best sphero-cylindrical refraction.
- Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having: Clear cornea, No anterior segment disorder, No clinically significant slit lamp findings (i.e. oedema, staining, scarring, vascularisation, infiltrates or abnormal opacities), No other active ocular disease or recent surgery
Who cannot join
- Having worn RGP contact lenses within the last 30 days or PMMA contact lenses within the last 3 months.
- Clinically significant corneal oedema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
- Extended lens wear in last 3 months.
- Any systemic or topical medications that will in the investigator's opinion affect ocular physiology or contact lens performance.
- Any systemic disease affecting ocular health.
- Abnormal lacrimal secretions.
Show all 14Show fewer
- Keratoconus or other corneal irregularity.
- Pregnancy, lactating or planning a pregnancy at the time of enrolment.
- Participation in any concurrent clinical trial.
- Any previous anterior ocular surgery.
- Subjects who are known to have an infectious systemic disease (e.g., hepatitis, tuberculosis).
- Subjects who are known to have an immunosuppressive disease (e.g., HIV positive).
- Subjects who are known to have diabetes.
- Employees or family members of the Research site, Principal Investigator or study team.
Trial locations and contacts
1 site in 1 country.
About this study
This study is evaluating the initial fit of toric contact lenses.
- Conditions
- Astigmatism, Myopia
- Being tested
- etafilcon A, nelfilcon A, Filcon II 3
- Medical subject headings
- Astigmatism, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etafilcon ADevice
Also called 1-DAY ACUVUE MOIST for Astigmatism
A daily wear contact lens
nelfilcon ADevice
Also called Focus Dailies Toric All Day Comfort
A daily wear contact lens
Filcon II 3Device
Also called Clariti(TM) 1 day Toric
a daily disposable
| Study group | Role | What they receive |
|---|---|---|
| etafilcon A / nelfilcon A / Filcon II 3 | Other | etafilcon A worn first then nelfilcon A worn second with Filcon II 3 worn third. Receives: Device: etafilcon A; Device: nelfilcon A; Device: Filcon II 3 |
| nelfilcon A / etafilcon A / Filcon II 3 | Other | nelfilcon A worn first then etafilcon A worn second with Filcon II 3 worn third. Receives: Device: etafilcon A; Device: nelfilcon A; Device: Filcon II 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Absolute Lens Rotation
At 1-min after lens insertion, lens orientation position was assessed on a scale of 0-180 degree on both eyes.
Measured: At 1-min after lens insertion during Phase I
Phase I: Absolute Lens Rotation
Lens orientation position as assessed on a scale of 0-180 on both eyes.
Measured: 3 min after lens insertion during Phase I
Secondary outcomes (2)
Phase I: Time to Lens Settling
With random insertion and natural blinking, the slit lamp video was used to measure the time of lens settling.
Measured: 5 minutes after lens insertion during Phase I
Phase I: Number of Blinks Until Settled
Number of blinks for the right eye was counted until lens settling using headcam video.
Measured: Baseline to 5 minutes during Phase I
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2012
- Study completionApr 2012
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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552876
- Sponsor's protocol ID
- CR-4582
- Status last verified
- May 2015
- First submitted
- 9 Mar 2012
- Last updated
- 19 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Evaluation of Soft Toric Lens Designs
- ClinicalTrials.gov ID
- NCT01552876
- Acronym / sponsor ID
- CR-4582
- Conditions
- Astigmatism, Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Posted 15 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is evaluating the initial fit of toric contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| etafilcon A / nelfilcon A / Filcon II 3 | Other | Device: etafilcon A, Device: nelfilcon A, Device: Filcon II 3etafilcon A worn first then nelfilcon A worn second with Filcon II 3 worn third. |
| nelfilcon A / etafilcon A / Filcon II 3 | Other | Device: etafilcon A, Device: nelfilcon A, Device: Filcon II 3nelfilcon A worn first then etafilcon A worn second with Filcon II 3 worn third. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be greater than or equal to 18 years old.
- Read, understand, and sign written Statement of Informed Consent.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Be existing soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
- Require a visual correction in both eyes (monovision allowed but no monofit).
Key exclusion criteria (14 listed)
- Having worn RGP contact lenses within the last 30 days or PMMA contact lenses within the last 3 months.
- Clinically significant corneal oedema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
- Extended lens wear in last 3 months.
- Any systemic or topical medications that will in the investigator's opinion affect ocular physiology or contact lens performance.
- Any systemic disease affecting ocular health.
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 |
|---|---|---|
| etafilcon AAlso: 1-DAY ACUVUE MOIST for AstigmatismA daily wear contact lens | Device | etafilcon A / nelfilcon A / Filcon II 3, nelfilcon A / etafilcon A / Filcon II 3 |
| nelfilcon AAlso: Focus Dailies Toric All Day ComfortA daily wear contact lens | Device | etafilcon A / nelfilcon A / Filcon II 3, nelfilcon A / etafilcon A / Filcon II 3 |
| Filcon II 3Also: Clariti(TM) 1 day Torica daily disposable | Device | etafilcon A / nelfilcon A / Filcon II 3, nelfilcon A / etafilcon A / Filcon II 3 |
Primary outcome
Phase I: Absolute Lens Rotation
Time frame: At 1-min after lens insertion during Phase I
At 1-min after lens insertion, lens orientation position was assessed on a scale of 0-180 degree on both eyes.
Phase I: Absolute Lens Rotation
Time frame: 3 min after lens insertion during Phase I
Lens orientation position as assessed on a scale of 0-180 on both eyes.
2 secondary outcomes
Phase I: Time to Lens Settling
Time frame: 5 minutes after lens insertion during Phase I
Phase I: Number of Blinks Until Settled
Time frame: Baseline to 5 minutes during Phase I
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Astigmatism
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing etafilcon A, nelfilcon A and Filcon II 3 in people with Astigmatism and Myopia, 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 9 inclusion and 14 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 19 Jun 2018. 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 15 Aug 2014). 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?
Phase I: Absolute Lens Rotation (time frame: At 1-min after lens insertion during Phase I). The study lists 2 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 19 Jun 2018.