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

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ClinicalTrials.gov Identifier: NCT01240122
Recruitment Status : Completed
First Posted : November 15, 2010
Results First Posted : June 11, 2012
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Brief Summary:
An investigational multi-purpose solution (MPS)was clinically evaluated against Biotrue MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.

Condition or disease Intervention/treatment Phase
Corneal Staining Device: Biotrue MPS Device: Investigational MPS Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Study Start Date : August 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Active Comparator: Biotrue MPS Device: Biotrue MPS
Multi-purpose contact lens care solution
Experimental: Investigational MPS Device: Investigational MPS
Multi-purpose contact lens care solution



Primary Outcome Measures :
  1. Corneal Staining by Wear Time [ Time Frame: 1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4 ]
    All participants were contact lenses wearers and were evaluated with a Corneal Staining at 1 hour, 2 hours, 4 hours and end of day. The corneal staining test is performed using fluorescein drops in the eye and ultraviolet illumination to determine if there has been any damage to the cornea from the use of the lens solutions or from the use of the contact lens.


Secondary Outcome Measures :
  1. Subjective Solution Preference [ Time Frame: Day 4 ]
    All subjects were asked which solution they prefer based on comfort level: Biotrue MPS, Investigational MPS, or no difference.

  2. Overall Ocular Comfort [ Time Frame: Day 4 ]
    All subjects were asked to rate their lens comfort at each visit based on an 11 point scale where 0 meant that the lens could not be tolerated and 10 indicated that the lens could not be felt.



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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:

  • 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): NCT01240122


Locations
United States, California
Abbott Medical Optics Inc
Santa Ana, California, United States, 92705
Sponsors and Collaborators
Abbott Medical Optics
Investigators
Principal Investigator: Eugenia Y Kao, OD AMO

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01240122     History of Changes
Other Study ID Numbers: COBR-109-9608
First Posted: November 15, 2010    Key Record Dates
Results First Posted: June 11, 2012
Last Update Posted: February 6, 2018
Last Verified: January 2018

Keywords provided by Abbott Medical Optics:
Corneal staining and comfort evaluation in normal, habitual contact lens wearers.