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Wettability of Contact Lenses With a Multi-Purpose Solution

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ClinicalTrials.gov Identifier: NCT00713076
Recruitment Status : Completed
First Posted : July 11, 2008
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

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

Condition or disease Intervention/treatment Phase
Vision Other: Polyquaternium-preserved Multi-purpose Lens Cleaning Solution 109182 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2007
Actual Primary Completion Date : March 2008

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: 1
Polyquaternium-preserved Multi-purpose solution
Other: Polyquaternium-preserved Multi-purpose Lens Cleaning Solution 109182
Lens Cleaning Solution Formulation Identification Number 109182



Primary Outcome Measures :
  1. Lens Wettability - ex-vivo wetting angle [ Time Frame: From baseline ]

Secondary Outcome Measures :
  1. Slit-lamp findings Corrected visual acuity (snellen) Adverse events [ Time Frame: From baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT00713076


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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00713076     History of Changes
Other Study ID Numbers: C-07-18
First Posted: July 11, 2008    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: July 2008

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

Additional relevant MeSH terms:
Pharmaceutical Solutions