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Effect of an Investigational Multi-Purpose Solution on Lens Moisture

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ClinicalTrials.gov Identifier: NCT01341990
Recruitment Status : Completed
First Posted : April 26, 2011
Results First Posted : April 13, 2012
Last Update Posted : April 13, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Contact Lens Moisture
Interventions Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)
Device: ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS)
Device: Silicone Hydrogel Contact Lenses
Enrollment 68
Recruitment Details Participants were recruited from 1 US study center.
Pre-assignment Details  
Arm/Group Title FID 114675A ReNu MultiPlus
Hide Arm/Group Description Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
Period Title: Overall Study
Started 35 33
Completed 32 32
Not Completed 3 1
Reason Not Completed
Adverse Event             0             1
Torn Study Lens             1             0
Withdrawal by Subject             2             0
Arm/Group Title FID 114675A ReNu MultiPlus Total
Hide Arm/Group Description Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses Total of all reporting groups
Overall Number of Baseline Participants 35 33 68
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 33 participants 68 participants
43.9  (9.2) 42.8  (11.2) 43.4  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 33 participants 68 participants
Female
23
  65.7%
22
  66.7%
45
  66.2%
Male
12
  34.3%
11
  33.3%
23
  33.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants 33 participants 68 participants
35 33 68
1.Primary Outcome
Title Mean Ex-Vivo Advancing Contact Angle
Hide Description Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.
Time Frame Day 1, 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat.
Arm/Group Title FID 114675A ReNu MultiPlus
Hide Arm/Group Description:
Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
Overall Number of Participants Analyzed 34 32
Mean (Standard Deviation)
Unit of Measure: Degrees
56.7  (21.2) 59.2  (23.7)
2.Primary Outcome
Title Mean Ex-Vivo Advancing Contact Angle
Hide Description Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.
Time Frame Day 8, 16 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat.
Arm/Group Title FID 114675A ReNu MultiPlus
Hide Arm/Group Description:
Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
Overall Number of Participants Analyzed 31 32
Mean (Standard Deviation)
Unit of Measure: Degrees
59.5  (21.2) 63.4  (17.5)
Time Frame Adverse events were collected for the duration of the study: 23 Nov 2009 to 27 Jan 2010.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FID 114675A ReNu MultiPlus
Hide Arm/Group Description Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
All-Cause Mortality
FID 114675A ReNu MultiPlus
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FID 114675A ReNu MultiPlus
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/33 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FID 114675A ReNu MultiPlus
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/33 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Alcon Clinical
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
EMail: medinfo@alconlabs.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01341990     History of Changes
Other Study ID Numbers: C-09-031
First Submitted: December 9, 2009
First Posted: April 26, 2011
Results First Submitted: March 21, 2012
Results First Posted: April 13, 2012
Last Update Posted: April 13, 2012