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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01240122
First received: November 8, 2010
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Corneal Staining
Device: Biotrue MPS
Device: Investigational MPS
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Resource links provided by NLM:


Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • Subjective Solution Preference [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
    Subject asked which solution they prefer based on comfort level.

  • Overall Ocular Comfort [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: August 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  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: 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
  More Information

No publications provided

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01240122     History of Changes
Other Study ID Numbers: COBR-109-9608
Study First Received: November 8, 2010
Results First Received: February 15, 2012
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 26, 2014