Effect of Head and Gaze Position on Soft Toric Contact Lens Performance
NCT ID: NCT01579045
Last Updated: 2018-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2012-08-31
2013-03-31
Brief Summary
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Senofilcon A will provide significantly less rotation with subjects in a recumbent position than Filcon II 3 monthly .
Etafilcon A will provide significantly less rotation with subjects in a recumbent position than Filcon II 3 1 1 day .
Etafilcon A will provide rotation with subjects a recumbent position non-inferior to nelfilcon A. A margin of 5 degrees will be used.
Secondary Hypotheses:
Senofilcon A will have significantly better monocular visual performance with subjects in a recumbent position than Filcon II 3 monthly.
Etafilcon A for astigmatism will have significantly better monocular visual performance with subjects in a recumbent position than Filcon II 3 1 day.
Etafilcon A will have monocular visual performance with subjects in a recumbent position non-inferior nelfilcon A. A margin of 0.05 LogMAR will be used.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Sequence 1
Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows:
Filcon II 3, nelfilcon A, etafilcon A, senofilcon A, Filcon II 3
senofilcon A
bilateral daily use soft contact lens
etafilcon A
bilateral daily use soft contact lens
nelfilcon A
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lenses
Sequence 2
Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows:
Filcon II 3, nelfilcon A, etafilcon A, Filcon II 3, senofilcon A
senofilcon A
bilateral daily use soft contact lens
etafilcon A
bilateral daily use soft contact lens
nelfilcon A
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lenses
Sequence 3
Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows:
Filcon II 3, etafilcon A, nelfilcon A, senofilcon A, Filcon II 3
senofilcon A
bilateral daily use soft contact lens
etafilcon A
bilateral daily use soft contact lens
nelfilcon A
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lenses
Sequence 4
Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows:
Filcon II 3, etafilcon A, nelfilcon A, Filcon II 3, senofilcon A
senofilcon A
bilateral daily use soft contact lens
etafilcon A
bilateral daily use soft contact lens
nelfilcon A
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lenses
Sequence 5
Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows:
nelfilcon A, Filcon II 3, etafilcon A, senofilcon A, Filcon II 3
senofilcon A
bilateral daily use soft contact lens
etafilcon A
bilateral daily use soft contact lens
nelfilcon A
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lenses
Sequence 6
Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows:
nelfilcon A, Filcon II 3, etafilcon A, Filcon II 3, senofilcon A
senofilcon A
bilateral daily use soft contact lens
etafilcon A
bilateral daily use soft contact lens
nelfilcon A
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lenses
Sequence 7
Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows:
nelfilcon A, etafilcon A, Filcon II 3, senofilcon A, Filcon II 3
senofilcon A
bilateral daily use soft contact lens
etafilcon A
bilateral daily use soft contact lens
nelfilcon A
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lenses
Sequence 8
Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows:
nelfilcon A, etafilcon A, Filcon II 3, Filcon II 3, senofilcon A
senofilcon A
bilateral daily use soft contact lens
etafilcon A
bilateral daily use soft contact lens
nelfilcon A
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lenses
Sequence 9
Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows:
etafilcon A, Filcon II 3, nelfilcon A, senofilcon A, Filcon II 3
senofilcon A
bilateral daily use soft contact lens
etafilcon A
bilateral daily use soft contact lens
nelfilcon A
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lenses
Sequence 10
Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows:
etafilcon A, Filcon II 3, nelfilcon A, Filcon II 3, senofilcon A
senofilcon A
bilateral daily use soft contact lens
etafilcon A
bilateral daily use soft contact lens
nelfilcon A
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lenses
Sequence 11
Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows:
etafilcon A, nelfilcon A, Filcon II 3, senofilcon A, Filcon II 3
senofilcon A
bilateral daily use soft contact lens
etafilcon A
bilateral daily use soft contact lens
nelfilcon A
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lenses
Sequence 12
Five separate sessions of bilateral lens wear of approximately 1 hour. This sequence is as follows:
etafilcon A, nelfilcon A, Filcon II 3, Filcon II 3, senofilcon A
senofilcon A
bilateral daily use soft contact lens
etafilcon A
bilateral daily use soft contact lens
nelfilcon A
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lenses
Interventions
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senofilcon A
bilateral daily use soft contact lens
etafilcon A
bilateral daily use soft contact lens
nelfilcon A
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lens
Filcon II 3
bilateral daily use soft contact lenses
Eligibility Criteria
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Inclusion Criteria
* Read, understand, and sign written Statement of Informed Consent.
* Appear able and willing to adhere to the instructions set forth in the 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 -1.00 to -6.00D.
* Have astigmatism of between -0.75 and -2.00DC in both eyes.
* Have axes of astigmatism within +/-10° of the following available lens axes: 70°, 90°, 110°, 20°, 180° \& 160°, i.e. 60-120, 10-30 and 150-180.
* Monocular distance visual acuity correctable to 6/9 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:
i) Clear cornea ii) No anterior segment disorder iii) No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularization, infiltrates or abnormal opacities) iv) No other active ocular disease or recent surgery
Exclusion Criteria
* Clinically significant corneal edema, corneal vascularization, 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.
* 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.
18 Years
55 Years
ALL
No
Sponsors
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Johnson & Johnson Vision Care, Inc.
INDUSTRY
Responsible Party
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Locations
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Farnham, Surrey, United Kingdom
Countries
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Other Identifiers
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CR-005141
Identifier Type: -
Identifier Source: org_study_id
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