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Trial record 50 of 11851 for:    Contact

Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens Care Solutions in Soft Contact Lens Wearers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01164865
Recruitment Status : Completed
First Posted : July 19, 2010
Results First Posted : October 12, 2012
Last Update Posted : October 12, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition Contact Lens Wear
Interventions Device: OPTI-FREE RepleniSH multipurpose disinfecting solution
Device: Clear Care contact lens care system
Device: Contact lenses
Enrollment 78
Recruitment Details Participants were recruited from two US study centers.
Pre-assignment Details  
Arm/Group Title OPTI-FREE RepleniSH Clear Care
Hide Arm/Group Description OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks. Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
Period Title: Overall Study
Started 39 39
Completed 37 38
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             2             1
Arm/Group Title OPTI-FREE RepleniSH Clear Care Total
Hide Arm/Group Description OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks. Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks. Total of all reporting groups
Overall Number of Baseline Participants 39 39 78
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 39 participants 78 participants
37.1  (12.27) 41.5  (9.59) 39.3  (11.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 39 participants 78 participants
Female
29
  74.4%
26
  66.7%
55
  70.5%
Male
10
  25.6%
13
  33.3%
23
  29.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants 39 participants 78 participants
39 39 78
1.Primary Outcome
Title Change From Baseline in Ocular Comfort Rating at 2 Weeks
Hide Description Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described "how your eyes feel right now."
Time Frame Baseline (Day 0), 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received regimen, satisfied the inclusion/exclusion criteria, and completed the 14-day treatment period, including completion of the Visit 2 evaluations.
Arm/Group Title OPTI-FREE RepleniSH Clear Care
Hide Arm/Group Description:
OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
Overall Number of Participants Analyzed 37 38
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-8.20
(-13.84 to -2.55)
-7.14
(-12.74 to -1.54)
2.Primary Outcome
Title Likert Questionnaire Scores at 2 Weeks
Hide Description The Likert Questionnaire included 8 questions on selected comfort measures. All responses were recorded on a 5-point scale, where 1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, and 5=Strongly Agree.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received regimen, satisfied the inclusion/exclusion criteria, and completed the 14-day treatment period, including completion of the Visit 2 evaluations.
Arm/Group Title OPTI-FREE RepleniSH Clear Care
Hide Arm/Group Description:
OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
Overall Number of Participants Analyzed 37 38
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
I can comfortably wear my lenses
4.20
(3.96 to 4.44)
4.24
(4.00 to 4.48)
My lenses stay moist from morning to evening
3.60
(3.28 to 3.92)
3.69
(3.37 to 4.01)
The solution I use feels gentle on my eyes
4.00
(3.75 to 4.25)
3.66
(3.41 to 3.91)
My lenses feel fresh
3.79
(3.52 to 4.05)
4.03
(3.77 to 4.29)
At the end of the day, my vision is clear
3.54
(3.20 to 3.88)
3.86
(3.52 to 4.19)
When I put my lenses in, they feel comfortable
4.05
(3.78 to 4.33)
4.03
(3.76 to 4.30)
I like the way this product feels during handling
4.09
(3.84 to 4.34)
3.66
(3.42 to 3.91)
My lenses feel moist
3.84
(3.56 to 4.12)
3.64
(3.36 to 3.92)
Time Frame Adverse events were collected for the duration of the study: 5 months, 3 weeks.
Adverse Event Reporting Description The safety population included all enrolled and exposed participants.
 
Arm/Group Title OPTI-FREE RepleniSH Clear Care
Hide Arm/Group Description OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks. Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
All-Cause Mortality
OPTI-FREE RepleniSH Clear Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
OPTI-FREE RepleniSH Clear Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/39 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OPTI-FREE RepleniSH Clear Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/39 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Alcon reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jami Kern, Ph.D.
Organization: Alcon Global Medical Affairs
Phone: 1-888-451-3937
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01164865    
Other Study ID Numbers: SMA-09-58
First Submitted: July 15, 2010
First Posted: July 19, 2010
Results First Submitted: September 13, 2012
Results First Posted: October 12, 2012
Last Update Posted: October 12, 2012