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Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues

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ClinicalTrials.gov Identifier: NCT01494818
Recruitment Status : Completed
First Posted : December 19, 2011
Results First Posted : September 27, 2013
Last Update Posted : September 27, 2013
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Supportive Care
Condition Contact Lens Care
Interventions Device: Hydrogen peroxide-based contact lens care system
Device: PHMB-containing contact lens solution
Device: Soft contact lenses
Enrollment 79
Recruitment Details Participants were recruited from one study center located in the United Kingdom.
Pre-assignment Details Of the 79 participants enrolled in the study, 1 participant exited the study between enrollment and product dispensing due to nonavailability. This reporting group includes all enrolled and dispensed participants.
Arm/Group Title CLEAR CARE/AOSEPT Plus ReNu MultiPlus
Hide Arm/Group Description Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Period Title: Overall Study
Started 39 39
Completed 37 37
Not Completed 2 2
Reason Not Completed
Relocation             1             2
Lost to Follow-up             1             0
Arm/Group Title CLEAR CARE/AOSEPT Plus ReNu MultiPlus Total
Hide Arm/Group Description Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months Total of all reporting groups
Overall Number of Baseline Participants 37 37 74
Hide Baseline Analysis Population Description
This reporting group includes all enrolled and dispensed participants who completed the study.
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 37 participants 74 participants
34.8  (9.8) 35.5  (10.5) 35.1  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 37 participants 74 participants
Female
21
  56.8%
25
  67.6%
46
  62.2%
Male
16
  43.2%
12
  32.4%
28
  37.8%
1.Primary Outcome
Title Maximum Papillae
Hide Description Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and dispensed participants who completed the study as per protocol
Arm/Group Title CLEAR CARE/AOSEPT Plus ReNu MultiPlus
Hide Arm/Group Description:
Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Overall Number of Participants Analyzed 37 37
Median (Full Range)
Unit of Measure: Units on a scale
Baseline (habitual contact lenses and care system)
2.0
(0 to 4)
2.0
(0 to 3)
Month 3
2.0
(0 to 3)
2.0
(0 to 3)
2.Primary Outcome
Title Maximum Eyelid Hyperaemia
Hide Description Eyelid hyperaemia (redness) was recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = Clear; 1 = Slight redness; 2 = Mild redness; 3 = Moderate redness; 4 = Severe redness). The maximum value represents the worst grade in any zone. Both eyes were included in the model for analysis.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and dispensed participants who completed the study as per protocol
Arm/Group Title CLEAR CARE/AOSEPT Plus ReNu MultiPlus
Hide Arm/Group Description:
Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Overall Number of Participants Analyzed 37 37
Median (Full Range)
Unit of Measure: Units on a scale
Baseline (habitual contact lenses and care system)
2.0
(1 to 4)
2.0
(1 to 4)
Month 3
2.0
(1 to 3)
2.0
(1 to 3)
3.Primary Outcome
Title Upper Lid Redness
Hide Description The contact lenses were removed and upper lid redness was objectively measured through digital images. The coverage of the palpebral surface by blood vessels is expressed as percentage of the total surface measured. Both eyes were included in the model for analysis.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and dispensed participants who completed the study as per protocol
Arm/Group Title CLEAR CARE/AOSEPT Plus ReNu MultiPlus
Hide Arm/Group Description:
Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Overall Number of Participants Analyzed 37 37
Mean (Standard Deviation)
Unit of Measure: Percentage of total surface measured
Baseline (habitual contact lenses and care system) 34.8  (6.8) 34.9  (6.1)
Month 3 35.2  (7.0) 35.4  (5.8)
4.Primary Outcome
Title Change From Baseline in Upper Eyelid Margin Staining at Month 3
Hide Description The contact lens was removed and ophthalmic dye was instilled. Upper eyelid margin staining was objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) was recorded. Both eyes were included in the model for analysis.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and dispensed participants who completed the study as per protocol
Arm/Group Title CLEAR CARE/AOSEPT Plus ReNu MultiPlus
Hide Arm/Group Description:
Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Overall Number of Participants Analyzed 37 37
Mean (Standard Deviation)
Unit of Measure: square millimeters
-0.014  (3.905) -0.754  (4.179)
5.Secondary Outcome
Title Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)
Hide Description The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eyelid and the contact lens). The time required for a dry spot to appear on the pre-lens surface after blinking is referred to as the pre-lens tear film break up time. PL-NIBUT was evaluated using a biomicroscope with a diffuse illumination source, i.e., Tearscope. A longer PL-NIBUT indicates a more stable tear film and greater on-eye lens wettability. Three PL-NIBUT measurements were recorded, and the median value was used for analysis. Both eyes were included in the model for analysis.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and dispensed participants who completed the study as per protocol
Arm/Group Title CLEAR CARE/AOSEPT Plus ReNu MultiPlus
Hide Arm/Group Description:
Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Overall Number of Participants Analyzed 37 37
Mean (Standard Deviation)
Unit of Measure: Seconds
Baseline (habitual contact lenses and care system) 4.05  (4.63) 5.08  (4.07)
Month 3 5.76  (4.50) 4.22  (2.12)
6.Secondary Outcome
Title Protective Index
Hide Description A digital video recording was made of the interblink period. The percentage of area of the visible contact lens covered by the tear film was calculated (Protected Area). The Protective Index is defined as the average tear coverage over the whole interblink period. Both eyes were included in the model for analysis.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and dispensed participants who completed the study as per protocol
Arm/Group Title CLEAR CARE/AOSEPT Plus ReNu MultiPlus
Hide Arm/Group Description:
Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Overall Number of Participants Analyzed 37 37
Mean (Standard Deviation)
Unit of Measure: Percent of visible contact lens surface
Baseline (habitual contact lenses and care system) 95.9  (11.0) 95.8  (10.2)
Month 3 96.4  (10.0) 97.8  (5.8)
7.Secondary Outcome
Title Median Front Lens Deposits
Hide Description Deposits present on the front surface of the lens were assessed with a biomicroscope while the lens was on eye. Deposits were rated on a 5-point forced choice scale (0 = none; 1 = slight; = mild; 3 = moderate; 4 = severe) in five lens zones. The median of the five zones was used for analysis. Both eyes were included in the model for analysis.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and dispensed participants who completed the study as per protocol
Arm/Group Title CLEAR CARE/AOSEPT Plus ReNu MultiPlus
Hide Arm/Group Description:
Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Overall Number of Participants Analyzed 37 37
Median (Full Range)
Unit of Measure: Units on a scale
Baseline (habitual contact lenses and care system)
0
(0 to 2)
0
(0 to 1)
Month 3
0
(0 to 0)
0
(0 to 2)
8.Secondary Outcome
Title Total Lipid Uptake Per Lens
Hide Description The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value would indicate a cleaner lens surface.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and dispensed participants who completed the study as per protocol
Arm/Group Title CLEAR CARE/AOSEPT Plus ReNu MultiPlus
Hide Arm/Group Description:
Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Overall Number of Participants Analyzed 37 37
Mean (Standard Deviation)
Unit of Measure: micrograms
Baseline (habitual contact lenses and care system) 38.95  (23.94) 36.44  (47.59)
Month 3 32.40  (24.53) 34.20  (26.57)
Time Frame Adverse events were collected for the duration of the study. The safety population includes all participants exposed to test product.
Adverse Event Reporting Description An adverse event was any untoward medical occurrence in a subject administered a test article, regardless of causal relationship with the treatment.
 
Arm/Group Title CLEAR CARE/AOSEPT Plus ReNu MultiPlus
Hide Arm/Group Description Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
All-Cause Mortality
CLEAR CARE/AOSEPT Plus ReNu MultiPlus
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
CLEAR CARE/AOSEPT Plus ReNu MultiPlus
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/39 (5.13%)      0/39 (0.00%)    
Skin and subcutaneous tissue disorders     
Hospitalization   1/39 (2.56%)  1 0/39 (0.00%)  0
Surgical and medical procedures     
Hysterectomy   1/39 (2.56%)  1 0/39 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CLEAR CARE/AOSEPT Plus ReNu MultiPlus
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/39 (7.69%)      0/39 (0.00%)    
Eye disorders     
Toxic reaction to solution   3/39 (7.69%)  4 0/39 (0.00%)  0
Indicates events were collected by systematic assessment
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.
Sponsor 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: Renee Garofalo, OD, FAAO
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01494818    
Other Study ID Numbers: ID 10-59 / M-11-02
First Submitted: December 15, 2011
First Posted: December 19, 2011
Results First Submitted: July 30, 2013
Results First Posted: September 27, 2013
Last Update Posted: September 27, 2013