Clinical Trial of Contact Lenses in Extended Wear

This study has been completed.
Sponsor:
Information provided by:
Vistakon
ClinicalTrials.gov Identifier:
NCT00762502
First received: September 26, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

To evaluate the effect of lens properties of the different types of contact lenses on the ocular health of existing contact lens wearers when used in an extended wear modality of up to seven days/six nights.


Condition Intervention
Astigmatism
Device: senofilcon A toric contact lens
Device: balafilcon A toric contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • conjunctival changes corneal changes superior palpebral changes [ Time Frame: Baseline, 24 hours, 1 week, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]

Enrollment: 112
Study Start Date: June 2007
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
senofilcon A toric
Device: senofilcon A toric contact lens
contact lens
Active Comparator: 2
balafilcon A toric
Device: balafilcon A toric contact lens
contact lens
Active Comparator: 3
senofilcon A toric in one eye, balafilcon A toric in the other eye
Device: senofilcon A toric contact lens
contact lens
Device: balafilcon A toric contact lens
contact lens

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to wear study lenses in parameters available
  • Non-presbyopes between the ages of 18-45
  • Understand and sign informed consent
  • Willing to follow the protocol
  • Achieve at least 20/30 (6/9) VA OD and OS with study lenses
  • Myopia -0.75 to -6.25, cylinder -0.75 to -1.50 D (axis 90 +/- 15, 180 +/- 15) or -1.75 D (axis 90 +/- 10, 180 +/- 10)
  • Adapted SCL wearer
  • Swims no more than once a week
  • Has a wearable pair of spectacles.

Exclusion Criteria:

  • Any ocular or systemic disorder which may contraindicate CL wear
  • Any topical ocular medication
  • Aphakic
  • Corneal refractive surgery
  • Corneal distortion from hard CL wear or keratoconus
  • Pregnant or lactating
  • Grade 2 or worse slit lamp signs
  • Infectious disease
  • Previous clinical study within 2 weeks
  • Don't agree to participate
  • PMMA or RGP wear in last 8 weeks
  • Previous AE's that contraindicate EW
  • Self-reported symptoms of itchiness or scratchiness with habitual lenses.
  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: NCT00762502

Locations
Australia, Victoria
Brennan Consultants
Hawthorn, Victoria, Australia
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Dr. John R. Buch / Principal Research Optometrist, Vistakon
ClinicalTrials.gov Identifier: NCT00762502     History of Changes
Other Study ID Numbers: CR-4498, JJG0704B3
Study First Received: September 26, 2008
Last Updated: September 26, 2008
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014