Effect of Eye Movement on Toric Lens Orientation and Visual Acuity
Status
Completed
Conditions
Astigmatism
Treatments
Device: balafilcon A
Device: omafilcon A
Device: senofilcon A
Device: lotrafilcon B
Details and patient eligibility
About
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).
Full description
Non-dispensing, single-masked (subject-masked), randomised, controlled study. Two visits.
Enrollment
40 patients
Sex
All
Ages
18 to 39 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- 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 design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Single Blind
40 participants in 19 patient groups
Group 2 LSBO
Active Comparator group
Description:
contact lenses worn in this order: lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric
Treatment:
Device: senofilcon A
Device: balafilcon A
Device: omafilcon A
Device: lotrafilcon B
Group 3 LOSB
Active Comparator group
Description:
contact lenses worn in this order: lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric
Treatment:
Device: senofilcon A
Device: balafilcon A
Device: omafilcon A
Device: lotrafilcon B
Group 4 LBSO
Active Comparator group
Description:
contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric
Treatment:
Device: senofilcon A
Device: balafilcon A
Device: omafilcon A
Device: lotrafilcon B
Group 5 LBOS
Active Comparator group
Description:
contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A
Treatment:
Device: senofilcon A
Device: balafilcon A
Device: omafilcon A
Device: lotrafilcon B
Group 6 SLOB
Active Comparator group
Description:
contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, omafilcon A toric, balafilcon A toric
Treatment:
Device: senofilcon A
Device: balafilcon A
Device: omafilcon A
Device: lotrafilcon B
Group 7 SLBO
Active Comparator group
Description:
contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric
Treatment:
Device: senofilcon A
Device: balafilcon A
Device: omafilcon A
Device: lotrafilcon B
Group 8 SOLB
Active Comparator group
Description:
contact lenses worn in this order: senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric
Treatment:
Device: senofilcon A
Device: balafilcon A
Device: omafilcon A
Device: lotrafilcon B
Group 9 SBLO
Active Comparator group
Description:
contact lenses worn in this order: senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric
Treatment:
Device: senofilcon A
Device: balafilcon A
Device: omafilcon A
Device: lotrafilcon B
Group 10 SBOL
Active Comparator group
Description:
contact lenses worn in this order: senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric
Treatment:
Device: senofilcon A
Device: balafilcon A
Device: omafilcon A
Device: lotrafilcon B
Group 11 OSLB
Active Comparator group
Description:
contact lenses worn in this order: omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric
Treatment:
Device: senofilcon A
Device: balafilcon A
Device: omafilcon A
Device: lotrafilcon B
Group 12 OSBL
Active Comparator group
Description:
contact lenses worn in this order: omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric
Treatment:
Device: senofilcon A
Device: balafilcon A
Device: omafilcon A
Device: lotrafilcon B
Group 13 OBLS
Active Comparator group
Description:
contact lenses worn in this order: omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric
Treatment:
Device: senofilcon A
Device: balafilcon A
Device: omafilcon A
Device: lotrafilcon B
Group 14 OBSL
Active Comparator group
Description:
contact lenses worn in this order: omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric
Treatment:
Device: senofilcon A
Device: balafilcon A
Device: omafilcon A
Device: lotrafilcon B
Group 15 BLSO
Active Comparator group
Description:
contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric
Treatment:
Device: senofilcon A
Device: balafilcon A
Device: omafilcon A
Device: lotrafilcon B
Group 16 BLOS
Active Comparator group
Description:
contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric
Treatment:
Device: senofilcon A
Device: balafilcon A
Device: omafilcon A
Device: lotrafilcon B
Group 17 BSOL
Active Comparator group
Description:
contact lenses worn in this order: balafilcon A toric, senofilcon A toric, omafilcon A toric, lotrafilcon B toric
Treatment:
Device: senofilcon A
Device: balafilcon A
Device: omafilcon A
Device: lotrafilcon B
Group 18 BOLS
Active Comparator group
Description:
contact lenses worn in this order: balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric
Treatment:
Device: senofilcon A
Device: balafilcon A
Device: omafilcon A
Device: lotrafilcon B
Group 19 BOSL
Active Comparator group
Description:
contact lenses worn in this order: balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric
Treatment:
Device: senofilcon A
Device: balafilcon A
Device: omafilcon A
Device: lotrafilcon B
Group 1 LSOB
Active Comparator group
Description:
contact lenses worn in this order: lotrafilcon B toric/senofilcon A toric/omafilconA toric/balafilcon A toric
Treatment:
Device: senofilcon A
Device: balafilcon A
Device: omafilcon A
Device: lotrafilcon B
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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