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OPTI-FREE® PureMoist® for Presbyopic 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: NCT02965820
Recruitment Status : Completed
First Posted : November 17, 2016
Results First Posted : April 26, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( Alcon, a Novartis Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition Presbyopia
Interventions Device: Opti-Free® PureMoist® contact lens solution
Device: Habitual Multi-Purpose Contact Lens Solution
Device: Habitual Contact Lenses
Enrollment 122
Recruitment Details Subjects were recruited from 8 study centers located in the United States.
Pre-assignment Details Of the 122 enrolled, 1 subject was exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (121).
Arm/Group Title OFPM/HMPS HMPS/OFPM
Hide Arm/Group Description OPTI-FREE® PureMoist® (OFPM) multi-purpose contact lens solution in Period 1, followed by subject’s habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject’s habitual contact lenses for approximately 30 cleaning and disinfection cycles. Subject’s habitual multi-purpose contact lens solution in Period1, followed by OPTI-FREE® PureMoist® contact lens solution in Period 2. Each product used daily per packaging instructions with subject’s habitual contact lenses for approximately 30 cleaning and disinfection cycles.
Period Title: Period 1, First 30 Days
Started 59 62
Completed 59 62
Not Completed 0 0
Period Title: Period 2, Second 30 Days
Started 58 [1] 62
Completed 57 61
Not Completed 1 1
Reason Not Completed
Adverse Event             1             1
[1]
One subject discontinued due to an AE after completion of Period 1 but before beginning Period 2.
Arm/Group Title Overall
Hide Arm/Group Description OFPM and HMPS used during Period 1 and Period 2 in a crossover assignment.
Overall Number of Baseline Participants 121
Hide Baseline Analysis Population Description
This analysis population includes all subjects exposed to study lens care products (Full Analysis Set).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 121 participants
52.7  (5.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants
Female
92
  76.0%
Male
29
  24.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants
Hispanic or Latino
2
   1.7%
Not Hispanic or Latino
119
  98.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
20
  16.5%
White
101
  83.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30
Hide Description CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms.
Time Frame Day 30, each product
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set with non-missing responses
Arm/Group Title OFPM HMPS
Hide Arm/Group Description:
OPTI-FREE® PureMoist® multi-purpose contact lens solution used daily per packaging instructions with subject’s habitual contact lenses for approximately 30 cleaning and disinfection cycles.
Subject’s habitual multi-purpose contact lens solution used daily per packaging instructions with subject’s habitual contact lenses for approximately 30 cleaning and disinfection cycles.
Overall Number of Participants Analyzed 120 119
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.4  (7.42) 15.8  (7.87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OFPM, HMPS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0030
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame Day 1 through study completion, an average of 60 days
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 investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
 
Arm/Group Title OFPM HMPS
Hide Arm/Group Description All subjects exposed to OPTI-FREE® PureMoist® multi-purpose contact lens solution All subjects exposed to habitual multi-purpose contact lens solution
All-Cause Mortality
OFPM HMPS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/121 (0.00%)   0/120 (0.00%) 
Hide Serious Adverse Events
OFPM HMPS
Affected / at Risk (%) Affected / at Risk (%)
Total   1/121 (0.83%)   0/120 (0.00%) 
Surgical and medical procedures     
Knee operation  1  1/121 (0.83%)  0/120 (0.00%) 
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OFPM HMPS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/121 (0.00%)   0/120 (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: Head, CDMA Vision Care Franchise
Organization: Alcon, A Novartis Division
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research ( Alcon, a Novartis Company )
ClinicalTrials.gov Identifier: NCT02965820    
Other Study ID Numbers: LCO115-P001
First Submitted: November 15, 2016
First Posted: November 17, 2016
Results First Submitted: March 20, 2018
Results First Posted: April 26, 2018
Last Update Posted: July 12, 2018