Text Size

Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00940459
First received: July 14, 2009
Last updated: July 11, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of this study was to evaluate the effect of different contact lens edge designs on the circumlimbal conjunctiva.


Condition Intervention
Contact Lenses
 Device: Senofilcon A contact lens (Acuvue Oasys)
Device: Comfilcon A contact lens (Biofinity)
Device: Lotrafilcon B contact lens (Air Optix)
Device: Balafilcon A contact lens (PureVision)
Device: Etafilcon A contact lens (Acuvue 2)
Device: Contact lens care system (EasySept)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Circumlimbal Conjunctival Staining (CCS) [ Time Frame: After 10 days of wear ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: June 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acuvue Oasys
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
 Device: Senofilcon A contact lens (Acuvue Oasys)
Silicone hydrogel contact lens CE-marked for the intended usage.
Other Name: ACUVUE® OASYS™
Device: Contact lens care system (EasySept)
Contact lens care system CE-marked for the intended usage.
Other Name: EasySept
Experimental: Biofinity
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
 Device: Comfilcon A contact lens (Biofinity)
Silicone hydrogel contact lens CE-marked for the intended usage.
Other Name: Biofinity®
Device: Contact lens care system (EasySept)
Contact lens care system CE-marked for the intended usage.
Other Name: EasySept
Experimental: Air Optix
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
 Device: Lotrafilcon B contact lens (Air Optix)
Silicone hydrogel contact lens CE-marked for the intended usage.
Other Name: Air Optix®
Device: Contact lens care system (EasySept)
Contact lens care system CE-marked for the intended usage.
Other Name: EasySept
Experimental: PureVision
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
 Device: Balafilcon A contact lens (PureVision)
Silicone hydrogel contact lens CE-marked for the intended usage.
Other Name: PureVision®
Device: Contact lens care system (EasySept)
Contact lens care system CE-marked for the intended usage.
Other Name: EasySept
Active Comparator: Acuvue 2
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
 Device: Etafilcon A contact lens (Acuvue 2)
Hydrogel contact lens CE-marked for the intended usage.
Other Name: ACUVUE® 2
Device: Contact lens care system (EasySept)
Contact lens care system CE-marked for the intended usage.
Other Name: EasySept

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Minimum age of 18 years old
  • Adapted contact lens wearer
  • Sign informed consent
  • Normal eyes with the exception of the need for visual correction
  • Astigmatism less than or equal to -0.75 diopter
  • Spherical prescription range between -10.00 and +6.00 diopters
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Any known sensitivity to the test articles used in the study
  • Monocular vision
  • Lid or conjunctival infections or abnormalities
  • Conjunctival staining greater than Grade 1
  • Corneal staining greater than Grade 2
  • Corneal edema or opacifications
  • Aphakia
  • Any previous corneal surgery
  • Iritis
  • Recent significant changes in visual acuity
  • Ocular disease that contraindicates contact lens wear
  • Tarsal abnormalities greater than Grade 2
  • Any ophthalmic medication
  • Any systemic medication or condition that might affect the subject's participation in the study
  • Chronic upper respiratory infections or colds
  • Pregnancy or planning to become pregnant
  • Lactation
  • Seasonal allergies
  • Known infections or immunosuppressive disease
  • Participation in other studies
  • Other protocol-defined exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940459

Locations
United Kingdom
Optometric Technology Group Ltd
London, United Kingdom
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00940459     History of Changes
Other Study ID Numbers: M-09-11
Study First Received: July 14, 2009
Last Updated: July 11, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Alcon Research:
contact lenses
conjunctival staining
contact lens wear

ClinicalTrials.gov processed this record on May 19, 2013