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Effect of Head and Gaze Position on Soft Toric Contact Lens Performance

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ClinicalTrials.gov Identifier: NCT01579045
Recruitment Status : Completed
First Posted : April 17, 2012
Results First Posted : October 3, 2014
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Astigmatism Myopia Device: senofilcon A Device: etafilcon A Device: nelfilcon A Device: Filcon II 3 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Head and Gaze Position on Soft Toric Contact Lens Performance
Study Start Date : August 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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

Device: senofilcon A
bilateral daily use soft contact lens

Device: etafilcon A
bilateral daily use soft contact lens

Device: nelfilcon A
bilateral daily use soft contact lens

Device: Filcon II 3
bilateral daily use soft contact lens

Device: Filcon II 3
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

Device: senofilcon A
bilateral daily use soft contact lens

Device: etafilcon A
bilateral daily use soft contact lens

Device: nelfilcon A
bilateral daily use soft contact lens

Device: Filcon II 3
bilateral daily use soft contact lens

Device: Filcon II 3
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

Device: senofilcon A
bilateral daily use soft contact lens

Device: etafilcon A
bilateral daily use soft contact lens

Device: nelfilcon A
bilateral daily use soft contact lens

Device: Filcon II 3
bilateral daily use soft contact lens

Device: Filcon II 3
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

Device: senofilcon A
bilateral daily use soft contact lens

Device: etafilcon A
bilateral daily use soft contact lens

Device: nelfilcon A
bilateral daily use soft contact lens

Device: Filcon II 3
bilateral daily use soft contact lens

Device: Filcon II 3
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

Device: senofilcon A
bilateral daily use soft contact lens

Device: etafilcon A
bilateral daily use soft contact lens

Device: nelfilcon A
bilateral daily use soft contact lens

Device: Filcon II 3
bilateral daily use soft contact lens

Device: Filcon II 3
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

Device: senofilcon A
bilateral daily use soft contact lens

Device: etafilcon A
bilateral daily use soft contact lens

Device: nelfilcon A
bilateral daily use soft contact lens

Device: Filcon II 3
bilateral daily use soft contact lens

Device: Filcon II 3
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

Device: senofilcon A
bilateral daily use soft contact lens

Device: etafilcon A
bilateral daily use soft contact lens

Device: nelfilcon A
bilateral daily use soft contact lens

Device: Filcon II 3
bilateral daily use soft contact lens

Device: Filcon II 3
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

Device: senofilcon A
bilateral daily use soft contact lens

Device: etafilcon A
bilateral daily use soft contact lens

Device: nelfilcon A
bilateral daily use soft contact lens

Device: Filcon II 3
bilateral daily use soft contact lens

Device: Filcon II 3
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

Device: senofilcon A
bilateral daily use soft contact lens

Device: etafilcon A
bilateral daily use soft contact lens

Device: nelfilcon A
bilateral daily use soft contact lens

Device: Filcon II 3
bilateral daily use soft contact lens

Device: Filcon II 3
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

Device: senofilcon A
bilateral daily use soft contact lens

Device: etafilcon A
bilateral daily use soft contact lens

Device: nelfilcon A
bilateral daily use soft contact lens

Device: Filcon II 3
bilateral daily use soft contact lens

Device: Filcon II 3
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

Device: senofilcon A
bilateral daily use soft contact lens

Device: etafilcon A
bilateral daily use soft contact lens

Device: nelfilcon A
bilateral daily use soft contact lens

Device: Filcon II 3
bilateral daily use soft contact lens

Device: Filcon II 3
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

Device: senofilcon A
bilateral daily use soft contact lens

Device: etafilcon A
bilateral daily use soft contact lens

Device: nelfilcon A
bilateral daily use soft contact lens

Device: Filcon II 3
bilateral daily use soft contact lens

Device: Filcon II 3
bilateral daily use soft contact lenses




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579045


Locations
United Kingdom
Farnham, Surrey, United Kingdom, GU97EN
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01579045     History of Changes
Other Study ID Numbers: CR-005141
First Posted: April 17, 2012    Key Record Dates
Results First Posted: October 3, 2014
Last Update Posted: June 19, 2018
Last Verified: May 2015

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases