Trial Outcomes & Findings for CLEAR CARE® PLUS for Presbyopic Contact Lens Wearers (NCT NCT02965833)
NCT ID: NCT02965833
Last Updated: 2018-07-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
126 participants
Primary outcome timeframe
Day 30, each product
Results posted on
2018-07-11
Participant Flow
Subjects were recruited from 9 study centers located in the United States.
Of the 126 enrolled, 5 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (121).
Participant milestones
| Measure |
CCP/HMPS
3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution (CCP) 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.
|
HMPS/CCP
Subject's habitual multi-purpose contact lens solution in Period 1, followed by 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix 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 1, First 30 Days of Wear
STARTED
|
67
|
54
|
|
Period 1, First 30 Days of Wear
COMPLETED
|
64
|
52
|
|
Period 1, First 30 Days of Wear
NOT COMPLETED
|
3
|
2
|
|
Period 2, Second 30 Days of Wear
STARTED
|
64
|
52
|
|
Period 2, Second 30 Days of Wear
COMPLETED
|
62
|
52
|
|
Period 2, Second 30 Days of Wear
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
CCP/HMPS
3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution (CCP) 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.
|
HMPS/CCP
Subject's habitual multi-purpose contact lens solution in Period 1, followed by 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix 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 1, First 30 Days of Wear
Adverse Event
|
0
|
1
|
|
Period 1, First 30 Days of Wear
Lost to Follow-up
|
1
|
1
|
|
Period 1, First 30 Days of Wear
Protocol Violation
|
1
|
0
|
|
Period 1, First 30 Days of Wear
Withdrawal by Subject
|
1
|
0
|
|
Period 2, Second 30 Days of Wear
Protocol Violation
|
2
|
0
|
Baseline Characteristics
CLEAR CARE® PLUS for Presbyopic Contact Lens Wearers
Baseline characteristics by cohort
| Measure |
Overall
n=121 Participants
3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix and subject's HMPS used during Period 1 and Period 2 in a crossover assignment.
|
|---|---|
|
Age, Continuous
|
52.5 years
STANDARD_DEVIATION 5.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
119 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
103 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 30, each productPopulation: Full Analysis Set with non-missing responses
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.
Outcome measures
| Measure |
CLEAR CARE PLUS
n=114 Participants
3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution used daily with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
|
HMPS
n=117 Participants
Subject's habitual multi-purpose contact lens solution used daily with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
|
|---|---|---|
|
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30
|
12.6 units on a scale
Standard Deviation 7.19
|
14.8 units on a scale
Standard Deviation 7.99
|
Adverse Events
CLEAR CARE PLUS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HMPS
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CLEAR CARE PLUS
n=121 participants at risk
All subjects exposed to CCP contact lens solution
|
HMPS
n=121 participants at risk
All subjects exposed to habitual multi-purpose contact lens solution
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/121 • Day 1 through study completion, an average of 60 days
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.
|
0.83%
1/121 • Day 1 through study completion, an average of 60 days
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.
|
Other adverse events
Adverse event data not reported
Additional Information
Head, CDMA Vision Care Franchise
Alcon, A Novartis Division
Phone: 1-888-451-3937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER