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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01579045
First received: April 13, 2012
Last updated: September 29, 2014
Last verified: September 2014

April 13, 2012
September 29, 2014
August 2012
March 2013   (final data collection date for primary outcome measure)
Lens Orientation in Recumbent Position [ Time Frame: up to 60 minutes in recumbent position ] [ Designated as safety issue: No ]
rotation from zero position also described as absolute value of the rotation.
Lens Orientation in recumbent position [ Time Frame: up to 60 minutes in recumbent position ] [ Designated as safety issue: No ]
rotation from zero position
Complete list of historical versions of study NCT01579045 on ClinicalTrials.gov Archive Site
Monocular Visual Acuity in Recumbent Position [ Time Frame: up to 60 minutes in recumbent position ] [ Designated as safety issue: No ]
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).
Monocular Visual Acuity in recumbent position [ Time Frame: up to 60 minutes in recumbent position ] [ Designated as safety issue: No ]
Visual Acuity
Not Provided
Not Provided
 
Effect of Head and Gaze Position on Soft Toric Contact Lens Performance
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Astigmatism
  • Myopia
  • 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 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

    Interventions:
    • Device: senofilcon A
    • Device: etafilcon A
    • Device: nelfilcon A
    • Device: Filcon II 3
    • Device: Filcon II 3
  • 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

    Interventions:
    • Device: senofilcon A
    • Device: etafilcon A
    • Device: nelfilcon A
    • Device: Filcon II 3
    • Device: Filcon II 3
  • 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

    Interventions:
    • Device: senofilcon A
    • Device: etafilcon A
    • Device: nelfilcon A
    • Device: Filcon II 3
    • Device: Filcon II 3
  • 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

    Interventions:
    • Device: senofilcon A
    • Device: etafilcon A
    • Device: nelfilcon A
    • Device: Filcon II 3
    • Device: Filcon II 3
  • 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

    Interventions:
    • Device: senofilcon A
    • Device: etafilcon A
    • Device: nelfilcon A
    • Device: Filcon II 3
    • Device: Filcon II 3
  • 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

    Interventions:
    • Device: senofilcon A
    • Device: etafilcon A
    • Device: nelfilcon A
    • Device: Filcon II 3
    • Device: Filcon II 3
  • 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

    Interventions:
    • Device: senofilcon A
    • Device: etafilcon A
    • Device: nelfilcon A
    • Device: Filcon II 3
    • Device: Filcon II 3
  • 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

    Interventions:
    • Device: senofilcon A
    • Device: etafilcon A
    • Device: nelfilcon A
    • Device: Filcon II 3
    • Device: Filcon II 3
  • 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

    Interventions:
    • Device: senofilcon A
    • Device: etafilcon A
    • Device: nelfilcon A
    • Device: Filcon II 3
    • Device: Filcon II 3
  • 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

    Interventions:
    • Device: senofilcon A
    • Device: etafilcon A
    • Device: nelfilcon A
    • Device: Filcon II 3
    • Device: Filcon II 3
  • 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

    Interventions:
    • Device: senofilcon A
    • Device: etafilcon A
    • Device: nelfilcon A
    • Device: Filcon II 3
    • Device: Filcon II 3
  • 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

    Interventions:
    • Device: senofilcon A
    • Device: etafilcon A
    • Device: nelfilcon A
    • Device: Filcon II 3
    • Device: Filcon II 3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
March 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01579045
CR-005141
No
Vistakon
Vistakon
Not Provided
Not Provided
Vistakon
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP