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Objective Testing of Tear Film Stability

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by:
Manhattan Vision Associates
ClinicalTrials.gov Identifier:
NCT00789529
First received: November 11, 2008
Last updated: December 3, 2008
Last verified: December 2008
History of Changes

November 11, 2008
December 3, 2008
September 2008
November 2008   (final data collection date for primary outcome measure)
Objective, in-vivo soft contact lens wettability [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00789529 on ClinicalTrials.gov Archive Site
Subject questionnaire responses [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Objective Testing of Tear Film Stability
Objective Testing of Tear Film Stability

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Contact Lens Solutions
  • Device: Opti-Free® RepleniSH® MPDS
    soft contact lens disinfecting solution
  • Device: ReNu MultiPlus®
    soft contact lens disinfecting solution
  • Active Comparator: 1
    Opti-Free® RepleniSH® MPDS
    Intervention: Device: Opti-Free® RepleniSH® MPDS
  • Active Comparator: 2
    Renu MultiPlus®
    Intervention: Device: ReNu MultiPlus®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
November 2008
November 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00789529
CS-101
No
Arkady Selenow, O.D., co-owner, Manhattan Vision Associates/Institute for Vision Research
Manhattan Vision Associates
Alcon Research
Principal Investigator: George Zikos, OS, MS MVA/IVR
Manhattan Vision Associates
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP