ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 1

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: NCT01684033
Recruitment Status : Completed
First Posted : September 12, 2012
Results First Posted : April 17, 2014
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Myopia
Hyperopia
Contact Lens Comfort
Interventions Device: Opti-Free® PureMoist® MPDS
Device: Biotrue™ MPS
Device: Habitual contact lenses
Enrollment 207
Recruitment Details Participants were recruited from 5 study centers located in the US, 3 study centers located in the UK, and 2 study centers located in Germany.
Pre-assignment Details Of the 207 enrolled, 9 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants who were exposed to a study regimen (test or control) (198).
Arm/Group Title PureMoist - Biotrue Biotrue - PureMoist
Hide Arm/Group Description Opti-Free® PureMoist® MPDS, followed by Biotrue™ MPS. Each product used as indicated for 30 days with participant's habitual contact lenses. Biotrue™ MPS, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
Period Title: Period 1, First 30 Days
Started 99 99
Completed 95 98
Not Completed 4 1
Reason Not Completed
Adverse Event             1             1
Noncompliance             1             0
Withdrawal by Subject             1             0
Lost to Follow-up             1             0
Period Title: Period 2, Second 30 Days
Started 95 98
Completed 94 98
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title PureMoist / Biotrue
Hide Arm/Group Description Opti-Free® PureMoist® MPDS and Biotrue™ MPS used during Period 1 and Period 2 in randomized order in crossover assignment.
Overall Number of Baseline Participants 198
Hide Baseline Analysis Population Description
This analysis population includes all participants who were exposed to a study regimen (test or control).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 198 participants
31.7  (11.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants
Female
151
  76.3%
Male
47
  23.7%
1.Primary Outcome
Title Corneal Staining
Hide Description Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.
Time Frame Day 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis population group includes all participants who were exposed to both treatment regimens.
Arm/Group Title PureMoist Biotrue
Hide Arm/Group Description:
Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
Overall Number of Participants Analyzed 192 192
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.9  (2.30) 2.8  (2.62)
2.Primary Outcome
Title Change From Baseline in Corneal Staining at Day 30
Hide Description Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.
Time Frame Baseline (Day 0), Day 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PureMoist Biotrue
Hide Arm/Group Description:
Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
Overall Number of Participants Analyzed 192 192
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.7  (2.59) 1.6  (2.91)
Time Frame Adverse events (AE) were collected for the duration of the study (4 months). AEs were elicited by non-direct questioning of the participant and spontaneous reporting by the participant. AEs were recorded at every visit.
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. This analysis population includes all participants who were exposed to a study regimen (test or control), based on treatment-specific exposure.
 
Arm/Group Title PureMoist Biotrue
Hide Arm/Group Description Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses. Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
All-Cause Mortality
PureMoist Biotrue
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PureMoist Biotrue
Affected / at Risk (%) Affected / at Risk (%)
Total   0/196 (0.00%)   0/194 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PureMoist Biotrue
Affected / at Risk (%) Affected / at Risk (%)
Total   0/196 (0.00%)   0/194 (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
Name/Title: Jessie Lemp, GMA Brand Lead
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01684033     History of Changes
Other Study ID Numbers: M-12-038
1941/ALC
First Submitted: September 10, 2012
First Posted: September 12, 2012
Results First Submitted: March 12, 2014
Results First Posted: April 17, 2014
Last Update Posted: April 17, 2014