Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

November 8, 2010
June 7, 2012
August 2010
November 2010   (final data collection date for primary outcome measure)
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.
  • corneal staining [ Time Frame: end of day, Day 4 ] [ Designated as safety issue: Yes ]
    Corneal staining was evaluated at the end of the day for of lens wear
  • Corneal staining [ Time Frame: 1 hour, Day 1 ] [ Designated as safety issue: Yes ]
    Corneal staining was evaluated after 1 hour of lens wear on day 1
  • Corneal staining [ Time Frame: 2-hours, day two ] [ Designated as safety issue: Yes ]
    Corneal staining was evaluated after 2 hours of lens wear on day 2
  • Corneal Staining [ Time Frame: 4 hours, Day 3 ] [ Designated as safety issue: Yes ]
    Corneal staining was evaluated after 4 hours of lens wear on day 3
Complete list of historical versions of study NCT01240122 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
    Subject asked about their comfort with level with both solutions.
Not Provided
Not Provided
 
Short-Term Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Corneal Staining
  • Device: Biotrue MPS
    Multi-purpose contact lens care solution
  • Device: Investigational MPS
    Multi-purpose contact lens care solution
  • Active Comparator: Biotrue MPS
    Intervention: Device: Biotrue MPS
  • Experimental: Investigational MPS
    Intervention: Device: Investigational MPS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01240122
COBR-109-9608
Not Provided
Abbott Medical Optics
Abbott Medical Optics
Not Provided
Principal Investigator: Eugenia Y Kao, OD AMO
Abbott Medical Optics
June 2012

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