AstigmatismNCT01180998
Clinical Evaluation of Two Toric Contact Lenses in Current Non-toric Lens Users
A study testing Senofilcon A Toric (AOfA) and Etafilcon A Toric (1DAMfA) in people with Astigmatism, run by Johnson & Johnson Vision Care, Inc. at 18 sites in United Kingdom.
Trial summary
The purpose of this study is to evaluate the clinical performance, defined as successful fit, of two toric contact lenses (one daily disposable and the other daily wear reusable contact lens to correct astigmatism) in current spherical soft contact lens wearers, contact lens drop-outs, and non-users of toric contact… Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Astigmatism
- What is being tested?
- Senofilcon A Toric (AOfA) and Etafilcon A Toric (1DAMfA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 18 sitesUnited Kingdom
- Study dates
- 1 Jun 2010to 1 Oct 2010
- Phase
- Interventional
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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects must satisfy the following conditions prior to inclusion in the study:
- One of the following:
- Spherical contact lens user (minimum of 2 months wear, four days a week, 8 hours a day)
- Contact Lens drop-out (no contact lens wear in the last 6 months but wearing glasses at least four days a week,8 hours a day)
- Neophyte (no habitual contact lens wear except for trial fits up to 1 week, but wearing glasses at least four days a week,8 hours a day For patients not currently wearing lenses, patient should have expressed a desire to try lenses.
- Between 16 and 60 years of age.
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- Have signed an informed consent form (documented by the investigator in the Case Report Form [CRF]).
- Distance requirement in the range of +4.00D to -9.00D (i.e. -10.00D refractive)
- Refractive astigmatism between -0.75D and -3.00D in both eyes.
- Have best corrected VA of 6/9 (20/30) or better in each eye.
- Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having:
- No amblyopia.
- No evidence of lid abnormality or infection.
- No conjunctival abnormality or infection.
- No clinically significant slit lamp findings (i.e. stromal haze, staining, scarring, vascularisation, infiltrates or abnormal opacities).
- No other active ocular disease.
- Presbyopes may be included (no monovision, no spectacles over contact lenses or bifocal glasses only)
Who cannot join
- Any of the following will render a subject ineligible for inclusion:
- Requires concurrent ocular medication.
- Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularisation, tarsal abnormalities, bulbar hyperaemia, limbal hyperaemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
- Corneal staining Grade 3 in more than two regions.
- Extended wear in the last 3 months.
- Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study.
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- Abnormal lachrymal secretions.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Keratoconus or other corneal irregularity.
- Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- Has diabetes.
- Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
- Pregnancy, lactating, or planning a pregnancy at the time of enrollment.
- Participation in any concurrent clinical trial or in last 60 days.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United Kingdom18 sites
Study site
Birmingham
Study site
Bristol
Study site
Broadstone, Dorset
Study site
Cardiff, South Glamorgan
Study site
Coventry, West Midlands
Study site
Croydon, Surrey
Study site
Hendon, London
Study site
Marlow, Bucks
Study site
Pinner, Middlesex
Study site
Portchester, Hampshire
Study site
Rawtenstall, Lancashire
Study site
Reading, Berkshire
Study site
Shanklin, Isle Of Wight
Study site
Sheffield
Study site
Southsea, Hampshire
Study site
St Albans, Herts
Study site
Teddington, Middlesex
Study site
Uxbridge, Middlesex
About this study
The purpose of this study is to evaluate the clinical performance, defined as successful fit, of two toric contact lenses (one daily disposable and the other daily wear reusable contact lens to correct astigmatism) in current spherical soft contact lens wearers, contact lens drop-outs, and non-users of toric contact lenses (neophytes).
- Conditions
- Astigmatism
- Being tested
- Senofilcon A Toric (AOfA), Etafilcon A Toric (1DAMfA)
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senofilcon A Toric (AOfA)Device
Soft toric contact lenses for astigmatism
Etafilcon A Toric (1DAMfA)Device
Soft toric contact lenses for astigmatism
| Study group | Role | What they receive |
|---|---|---|
| Spherical contact lens users | Other | Habitual spherical contact lens (non-toric lens) users tried one of two toric lenses in a daily wear modality. Receives: Device: Senofilcon A Toric (AOfA); Device: Etafilcon A Toric (1DAMfA) |
| Contact lens drop-outs | Other | Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, tried one of two toric lenses in a daily wear modality. Receives: Device: Senofilcon A Toric (AOfA); Device: Etafilcon A Toric (1DAMfA) |
| Habitual Correction with Spectacles (Neophytes) | Other | Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses tried one of two toric lenses in a daily wear modality. Receives: Device: Senofilcon A Toric (AOfA); Device: Etafilcon A Toric (1DAMfA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Success in Fitting With a Toric Contact Lens
Percent of subjects with success with toric lens fitting defined as meeting all of the following pre-determined criteria: 1) acceptable fit, 2) orientation stability less than or equal to 20 degree rotation, 3) binocular visual acuity (VA) within one line of spectacle VA, 4) Good, very good, or excellent overall quality of Vision, and 5) good, very, good, or excellent overall lens comfort. There was not an inferential statistical analysis conducted on this outcome. Comparison was made through the use of 95% CI's for the proportions. Therefore no statistical analysis section is included for this primary outcome.
Measured: 4 weeks
Distance Visual Acuity
Measured monocularly (each eye separately) in Snellen converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.
Measured: after 1 week of toric contact lens wear
Distance Visual Acuity (VA)
Visual Acuity is measured monocularly (each eye separately) in Snellen, the converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.
Measured: after 4 weeks of toric contact lens wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study start1 Jun 2010
- Primary completion1 Oct 2010
- Study completion1 Oct 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Visioncare Research Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180998
- Sponsor's protocol ID
- CR-201004
- Status last verified
- Jun 2017
- First submitted
- 11 Aug 2010
- Last updated
- 19 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes