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
  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:


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 April 23, 2014