ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens

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.
ClinicalTrials.gov Identifier: NCT00754338
Recruitment Status : Completed
First Posted : September 18, 2008
Results First Posted : September 20, 2010
Last Update Posted : October 5, 2010
Sponsor:
Collaborator:
Alcon Research
Information provided by:
University of Waterloo

Brief Summary:
The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format.

Condition or disease Intervention/treatment Phase
Ametropia Drug: Alcon Opti-Free® RepleniSH® with Supraclens® Drug: Alcon Opti-Free® RepleniSH® Drug: B&L ReNu MultiPlus™ Not Applicable

Detailed Description:
The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format by observing changes within the cornea and collecting subjective ratings.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens
Study Start Date : January 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : September 2008

Arm Intervention/treatment
Active Comparator: Phase1 - Arm 1 Drug: Alcon Opti-Free® RepleniSH® with Supraclens®
Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover
Drug: Alcon Opti-Free® RepleniSH®
Marketed Multipurpose Disinfecting Care System
Active Comparator: Phase1 - Arm 2 Drug: Alcon Opti-Free® RepleniSH® with Supraclens®
Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover
Drug: Alcon Opti-Free® RepleniSH®
Marketed Multipurpose Disinfecting Care System
Active Comparator: Phase 2 - Arm 1 Drug: Alcon Opti-Free® RepleniSH® with Supraclens®
Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover
Drug: B&L ReNu MultiPlus™
Marketed Multipurpose Disinfecting Care Systems
Active Comparator: Phase 2 - Arm 2 Drug: Alcon Opti-Free® RepleniSH® with Supraclens®
Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover
Drug: B&L ReNu MultiPlus™
Marketed Multipurpose Disinfecting Care Systems



Primary Outcome Measures :
  1. Comfort [ Time Frame: 4 weeks ]
    Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'.

  2. Lens Wettability [ Time Frame: 4 weeks ]
    Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced).

  3. Lens Deposits [ Time Frame: 4 weeks ]
    Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits).


Secondary Outcome Measures :
  1. Dryness [ Time Frame: 4 weeks ]
    Subjective dryness ratings on analog scale (0= very dry; 100= not dry at all), self report by subject based on single criterion 'dryness'.

  2. Subjective Vision [ Time Frame: 4 weeks ]
    Subjective vision ratings on analog scale (0= poor vision; 100= excellent vision), self report by subject based on single criterion 'vision'.

  3. Corneal Staining [ Time Frame: 4 weeks ]

    Grading based on Type (0=None; 100=patch)and extent of staining (0=None; 100= Entire corneal region). Final value is Type multiplied by Extent.

    Corneal staining is a test that uses an orange dye (fluorescein) and a blue light to detect damage to the cornea (front surface of eye) from minor abrasions.

    A strip of blotting paper containing the dye was touched to the eyelid margin. Upon blinking, the dye spreads and coats the front surface of the eye along with the tear film covering the surface of the cornea. The investigator then rated the size, location and shape of the staining.




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:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Is at least 17 years of age and has full legal capacity to volunteer.
  • Has read, understood and signed an information consent letter.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.
  • Has clear corneas and no active ocular disease.
  • Has had an ocular examination in the last two years.
  • Is a current soft lens wearer, replacing their lenses every two weeks to one month.
  • Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fit with the study lens.
  • Has astigmatism less than or equal to -1.00 DC.

Exclusion Criteria:

  • Has any signs or symptoms of dry eye.
  • Has any clinically significant blepharitis.
  • Has undergone corneal refractive surgery.
  • Is aphakic.
  • Has any active ocular disease.
  • Has any systemic disease affecting ocular health.
  • Is using any systemic or topical medications that may affect ocular health.
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
  • Is pregnant or lactating.
  • Is participating in any other type of clinical or research study.
  • Currently wears daily disposable lenses.
  • Currently wears lenses on an extended wear basis.

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): NCT00754338


Locations
Canada, Ontario
Centre for Contact Lens Research, School of Optometry, University of Waterloo.
Waterloo, Ontario, Canada, N2L3G1
Sponsors and Collaborators
University of Waterloo
Alcon Research
Investigators
Study Chair: Desmond Fonn, MOptom University of Waterloo

Responsible Party: Desmond Fonn, MOptom., Centre for Contact Lens Research
ClinicalTrials.gov Identifier: NCT00754338     History of Changes
Other Study ID Numbers: P/279/07/L
First Posted: September 18, 2008    Key Record Dates
Results First Posted: September 20, 2010
Last Update Posted: October 5, 2010
Last Verified: September 2010

Keywords provided by University of Waterloo:
comfort
wetability
protein deposit
lipid deposit

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases
Dipivefrin
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs