- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01579045
Effect of Head and Gaze Position on Soft Toric Contact Lens Performance
Primary Hypotheses:
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Surrey
-
Farnham, Surrey, United Kingdom, GU97EN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age range 18-60 years.
- 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:
- Having worn rigid gas permeable (RGP) contact lenses within the last 30 days or polymethyl methacrylate (PMMA) contact lenses within the last 3 months.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 |
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lenses
|
Experimental: 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 |
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lenses
|
Experimental: 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 |
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lenses
|
Experimental: 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 |
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lenses
|
Experimental: 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 |
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lenses
|
Experimental: 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 |
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lenses
|
Experimental: 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 |
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lenses
|
Experimental: 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 |
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lenses
|
Experimental: 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 |
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lenses
|
Experimental: 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 |
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lenses
|
Experimental: 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 |
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lenses
|
Experimental: 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 |
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lens
bilateral daily use soft contact lenses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lens Orientation in Recumbent Position
Time Frame: up to 60 minutes in recumbent position
|
rotation from zero position also described as absolute value of the rotation.
|
up to 60 minutes in recumbent position
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Monocular Visual Acuity in Recumbent Position
Time Frame: up to 60 minutes in recumbent position
|
Visual Acuity measured in LogMAR units.
High contrast visual acuity (VA) was measured in both eyes using a 3m LogMAR test chart at 2.5m testing distance (subsequently converted).
|
up to 60 minutes in recumbent position
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-005141
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Astigmatism
-
Ohio State UniversityCompletedAstigmatism BilateralUnited States
-
Coopervision, Inc.Completed
-
Cairo UniversityUnknown
-
Assiut UniversityCompleted
-
Ashford and St. Peter's Hospitals NHS TrustBausch & Lomb IncorporatedUnknown
-
Carl Zeiss Meditec, Inc.CompletedMixed AstigmatismUnited States
-
Johnson & Johnson Vision Care, Inc.Completed
-
Ziemer Ophthalmic Systems AGTigermed Consulting Co., LtdRecruitingMyopic AstigmatismChina
-
Bausch & Lomb IncorporatedCompleted
-
Staar Surgical CompanyActive, not recruiting
Clinical Trials on senofilcon A
-
Johnson & Johnson Vision Care, Inc.Completed
-
Johnson & Johnson Vision Care, Inc.CompletedLapsed Contact Lens WearUnited States
-
Johnson & Johnson Vision Care, Inc.Completed
-
Johnson & Johnson Vision Care, Inc.CompletedCorrection of Refraction Error | Attenuation of Bright LightUnited States
-
Johnson & Johnson Vision Care, Inc.Completed
-
Johnson & Johnson Vision Care, Inc.CompletedVisual AcuityUnited States
-
Johnson & Johnson Vision Care, Inc.Completed
-
Johnson & Johnson Vision Care, Inc.Completed
-
Johnson & Johnson Vision Care, Inc.CompletedVisual AcuityUnited States