Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    "Astigmatism" | "Miconazole"
Previous Study | Return to List | Next Study

Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution

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: NCT01809197
Recruitment Status : Completed
First Posted : March 12, 2013
Results First Posted : July 22, 2014
Last Update Posted : July 22, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Supportive Care
Conditions Refractive Error
Myopia
Hyperopia
Astigmatism
Presbyopia
Interventions Device: Lotrafilcon B contact lenses
Device: Senofilcon A contact lenses
Device: OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS)
Device: Habitual Multi-Purpose Solution (MPS)
Enrollment 387
Recruitment Details Subjects were recruited from 22 study sites located in the US.
Pre-assignment Details Of the 387 enrolled, 15 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (372).
Arm/Group Title Air Optix/OFPM Acuvue Oasys/Habitual MPS
Hide Arm/Group Description Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
Period Title: Overall Study
Started 187 185
Completed 177 177
Not Completed 10 8
Reason Not Completed
Lost to Follow-up             4             2
Adverse Event             2             3
Failed slit lamp exam             1             0
Non-Compliance             1             1
Decision Unrelated to an Adverse Event             1             0
Withdrawal by Subject             1             1
Product not available             0             1
Arm/Group Title Air Optix/OFPM Acuvue Oasys/Habitual MPS Total
Hide Arm/Group Description Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system Total of all reporting groups
Overall Number of Baseline Participants 187 184 371
Hide Baseline Analysis Population Description
This analysis population includes all subjects who were randomized and received study regimen (test or control). Note: 1 subject randomized to Acuvue Oasys was not dispensed with study lenses.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 187 participants 184 participants 371 participants
32.4  (10.12) 35.0  (11.14) 33.7  (10.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 187 participants 184 participants 371 participants
Female
141
  75.4%
142
  77.2%
283
  76.3%
Male
46
  24.6%
42
  22.8%
88
  23.7%
1.Primary Outcome
Title Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses"
Hide Description Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree.
Time Frame Day 30; after 4 hours of lens wear
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who were randomized and received study regimen (test or control) with a Day 30 response to this Likert item.
Arm/Group Title Air Optix/OFPM Acuvue Oasys/Habitual MPS
Hide Arm/Group Description:
Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
Overall Number of Participants Analyzed 178 177
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
4.2  (0.90) 4.4  (0.66)
Time Frame Adverse events (AEs) were collected for duration of study (3 months). This analysis group includes all subjects who were randomized and received study regimen (test or control). Note: 1 subject randomized to Acuvue Oasys was not dispensed study lenses.
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device. AE data were collected at each study visit.
 
Arm/Group Title Air Optix/OFPM Acuvue Oasys/Habitual MPS
Hide Arm/Group Description Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
All-Cause Mortality
Air Optix/OFPM Acuvue Oasys/Habitual MPS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Air Optix/OFPM Acuvue Oasys/Habitual MPS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/187 (0.00%)   0/184 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Air Optix/OFPM Acuvue Oasys/Habitual MPS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/187 (0.00%)   0/184 (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.
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: Jessie Lemp, GMA Brand Lead - Vision Care
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: NCT01809197     History of Changes
Other Study ID Numbers: M-12-056
First Submitted: March 8, 2013
First Posted: March 12, 2013
Results First Submitted: June 25, 2014
Results First Posted: July 22, 2014
Last Update Posted: July 22, 2014