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Wettability of Contact Lenses With a Multi-Purpose Solution

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00713076
First received: June 18, 2008
Last updated: July 10, 2008
Last verified: July 2008
History of Changes
  Purpose

Measure wettability of hydrogel and silicone hydrogel contact lenses presoaked in a Multi-Purpose Solution.


Condition Intervention
Vision
 Other: Polyquaternium-preserved Multi-purpose Lens Cleaning Solution 109182

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

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:
  • Lens Wettability - ex-vivo wetting angle [ Time Frame: From baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Slit-lamp findings Corrected visual acuity (snellen) Adverse events [ Time Frame: From baseline ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2007
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Polyquaternium-preserved Multi-purpose solution
 Other: Polyquaternium-preserved Multi-purpose Lens Cleaning Solution 109182
Lens Cleaning Solution Formulation Identification Number 109182

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects with normal eyes who have successfully worn contact lenses on a daily basis for at least two weeks prior to the study.
  • Must be wearing lenses a minimum of eight hours a day
  • Vision must be correctable to 20/30 (snellen) or better in each eye at a distance with soft contact lenses
  • Use no topical ocular OTC or prescribed ocular medication

Exclusion Criteria:

  • Subjects with current lid or conjunctival infections, abnormalities, inflammation, abnormal corneal opacities, significant lenticular inclusions, iritis, ocular disease or condition, corneal surgery, cataract surgery, intraocular lens implants, or glaucoma filtering surgery.
  • Subjects using systemic medications, upper respiratory infections or colds, history of seasonal allergies with significant ocular side effects
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713076

Locations
United States, Texas
Contact Alcon Call Center for Study Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Renee Garofalo, Alcon
ClinicalTrials.gov Identifier: NCT00713076     History of Changes
Other Study ID Numbers: C-07-18
Study First Received: June 18, 2008
Last Updated: July 10, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
multi-purpose solution
contact lens wearers
Contact lense wearers

ClinicalTrials.gov processed this record on May 16, 2013