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Comparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions

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ClinicalTrials.gov Identifier: NCT01024855
Recruitment Status : Completed
First Posted : December 3, 2009
Results First Posted : March 29, 2012
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Brief Summary:
A new multi-purpose solution (MPS)was clinically evaluated against Opti-Free RepleniSH MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.

Condition or disease Intervention/treatment Phase
Myopia Hyperopia Astigmatism Device: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
Experimental: RevitaLens OcuTec Multipurpose Solution (Investigational MPS) Device: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)
multi-purpose lens care solution

Active Comparator: Opti-Free RepleniSH Multipurpose Solution (MPS, Control) Device: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)
multi-purpose lens care solution




Primary Outcome Measures :
  1. Number of Eyes With No Change in Corneal Staining [ Time Frame: Change from baseline after 1, 2, 4 and 6+ hours of wear ]
    Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • were at least 18 years old;
  • were experienced contact lens wearers;
  • were correctable to at least 20/40 or better in both eyes with contact lenses;
  • were in good general health, with healthy eyes (other than requiring vision correction);
  • had not worn lenses for at least 12 hours before each baseline visit;
  • had a corneal staining score no greater than Grade 1 in either eye at time of enrollment;
  • had previously used an MPS or hydrogen peroxide solution successfully.

Exclusion Criteria:

  • had a confirmed diagnosis of Sjögren's syndrome or other condition that results in a chronic and/or pathologic dry eye condition;
  • required concurrent ocular medication or have used ocular medication within 24 hours of entering the study;
  • had a known sensitivity or intolerance to any MPS, study products or ingredient(s);
  • were currently participating in any other clinical study;
  • had a condition or are in a situation that, in the investigator's opinion, may put them at significant risk, confound the study results, or interfere significantly with their participation in the study.

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): NCT01024855


Locations
United States, California
Abbott Medical Optics Inc.
Santa Ana, California, United States, 92705
Sponsors and Collaborators
Abbott Medical Optics

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01024855     History of Changes
Other Study ID Numbers: COBR-106-9608
First Posted: December 3, 2009    Key Record Dates
Results First Posted: March 29, 2012
Last Update Posted: October 20, 2015
Last Verified: March 2012

Additional relevant MeSH terms:
Astigmatism
Hyperopia
Refractive Errors
Eye Diseases
Pharmaceutical Solutions