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Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00940459
First Posted: July 16, 2009
Last Update Posted: November 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  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 (Participant, 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00940459


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

Publications:
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00940459     History of Changes
Other Study ID Numbers: M-09-11
First Submitted: July 14, 2009
First Posted: July 16, 2009
Last Update Posted: November 16, 2016
Last Verified: July 2012

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