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: December 17, 2013
Last verified: December 2013
  Purpose

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 Intervention
Astigmatism
Myopia
Device: senofilcon A
Device: etafilcon A
Device: nelfilcon A
Device: Filcon II 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Head and Gaze Position on Soft Toric Contact Lens Performance

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Lens Orientation in recumbent position [ Time Frame: up to 60 minutes in recumbent position ] [ Designated as safety issue: No ]
    rotation from zero position


Secondary Outcome Measures:
  • Monocular Visual Acuity in recumbent position [ Time Frame: up to 60 minutes in recumbent position ] [ Designated as safety issue: No ]
    Visual Acuity


Enrollment: 24
Study Start Date: August 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579045

Locations
United Kingdom
Farnham, Surrey, United Kingdom, GU97EN
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01579045     History of Changes
Other Study ID Numbers: CR-005141
Study First Received: April 13, 2012
Last Updated: December 17, 2013
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Astigmatism
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 26, 2014