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Objective Testing of Tear Film Stability

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Manhattan Vision Associates
ClinicalTrials.gov Identifier:
NCT00789529
First received: November 11, 2008
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose
The purpose of this study is to evaluate the in-vivo wettability of soft contact lenses when cared with two different multi-purpose solutions over a two week wearing period.

Condition Intervention
Contact Lens Solutions
 Device: Opti-Free® RepleniSH® MPDS
Device: ReNu MultiPlus®

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Objective Testing of Tear Film Stability

Resource links provided by NLM:

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

Further study details as provided by Manhattan Vision Associates:

Primary Outcome Measures:
  • Objective, In-vivo Soft Contact Lens Wettability Index [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The wettability index is derived from the slope of a metric developed to measure the regularity of the Shack-Hartmann wavefront sensor image. The more wettable a lens is the more stable the metric and the slope of the metric (the wettability index) is closer to zero. The more negative values indicate a less wettable the lens.


Secondary Outcome Measures:
  • Subject Questionnaire Response [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

    Subject questionnaire response: Overall comfort at 2 weeks in a 0-50 point scale.

    0=Very poor 50 = Excellent
Enrollment: 32
Study Start Date: September 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Opti-Free® RepleniSH® MPDS
 Device: Opti-Free® RepleniSH® MPDS
soft contact lens disinfecting solution
Active Comparator: 2
Renu MultiPlus®
 Device: ReNu MultiPlus®
soft contact lens disinfecting solution

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The subject must be at least 18 years of age and no more than 80 years of age.
  2. The subject must have a best corrected visual acuity of 20/30 or better for each eye.
  3. The subject must habitually wear contact lenses.
  4. The subject must have had an eye exam within the last 12 months. The exam data must be available to the investigators prior to the first visit.
  5. The subject must have normal eyes, no use of ocular medications, no ocular infection of any type, and no ocular inflammation.
  6. The subject must read understand and sign the Statement of Informed Consent.
  7. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

  1. Ocular or systemic allergies or disease that might interfere with contact lens wear.
  2. Systemic disease, autoimmune disease or use of medication which might interfere with contact lens wear.
  3. Clinically significant (FDA Scale grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormalities of the cornea which would contraindicate contact lens wear.
  4. Clinically significant (FDA Scale grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
  5. Any ocular infection.
  6. Pregnancy or lactation.
  7. Diabetes
  8. Infectious diseases (e.g. hepatitis, tuberculosis)
  9. Contagious immunosuppressive diseases (e.g. HIV)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789529

Locations
United States, New York
MVA/IVR
New York City, New York, United States, 10022
Sponsors and Collaborators
Manhattan Vision Associates
Alcon Research
Investigators
Principal Investigator: George Zikos, OS, MS MVA/IVR
  More Information

Responsible Party: Manhattan Vision Associates
ClinicalTrials.gov Identifier: NCT00789529     History of Changes
Other Study ID Numbers: CS-101 
Study First Received: November 11, 2008
Results First Received: July 25, 2011
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Manhattan Vision Associates:
Contact lenses, wettability, Contact Lens Disinfectant Solutions, pre-lens tear film

ClinicalTrials.gov processed this record on September 23, 2016