Trial Outcomes & Findings for Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald) (NCT NCT00520351)
NCT ID: NCT00520351
Last Updated: 2010-09-16
Results Overview
High Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart. 10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
30 participants
Primary outcome timeframe
2 weeks
Results posted on
2010-09-16
Participant Flow
Study completion date is August 2008
Washout for 2 to 3 days following screening (wear spectacles only).
Participant milestones
| Measure |
ClearCare First, Then Optifree Replenish
In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
|
Optifree Replenish First, Then ClearCare
In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
|
|---|---|---|
|
First Intervention
STARTED
|
15
|
15
|
|
First Intervention
COMPLETED
|
14
|
14
|
|
First Intervention
NOT COMPLETED
|
1
|
1
|
|
Second Intervention
STARTED
|
14
|
14
|
|
Second Intervention
COMPLETED
|
14
|
14
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
ClearCare First, Then Optifree Replenish
In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
|
Optifree Replenish First, Then ClearCare
In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)
Baseline characteristics by cohort
| Measure |
ClearCare First, Then Optifree Replenish
n=15 Participants
In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
|
Optifree Replenish First, Then ClearCare
n=15 Participants
In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
24.4 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
24.1 years
STANDARD_DEVIATION 4.4 • n=7 Participants
|
24.3 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksHigh Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart. 10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.
Outcome measures
| Measure |
ClearCare First, Then Optifree Replenish
n=28 Participants
In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
|
Optifree Replenish First, Then ClearCare
n=28 Participants
In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
|
|---|---|---|
|
High Contrast Visual Acuity
|
-0.04 logMAR
Standard Deviation 0.06
|
-0.04 logMAR
Standard Deviation 0.06
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Analysis was per protocol
Low Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart. 10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.
Outcome measures
| Measure |
ClearCare First, Then Optifree Replenish
n=28 Participants
In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
|
Optifree Replenish First, Then ClearCare
n=28 Participants
In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
|
|---|---|---|
|
Low Contrast Visual Acuity
|
0.26 logMAR
Standard Deviation 0.07
|
0.25 logMAR
Standard Deviation 0.08
|
PRIMARY outcome
Timeframe: 2 weeksPre-lens non-invasive tear breakup time
Outcome measures
| Measure |
ClearCare First, Then Optifree Replenish
n=28 Participants
In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
|
Optifree Replenish First, Then ClearCare
n=28 Participants
In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
|
|---|---|---|
|
In-vivo Wettability
|
7.06 Seconds
Interval 5.8 to 8.3
|
6.54 Seconds
Interval 5.7 to 7.4
|
PRIMARY outcome
Timeframe: 2 weeksNumeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort.
Outcome measures
| Measure |
ClearCare First, Then Optifree Replenish
n=28 Participants
In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
|
Optifree Replenish First, Then ClearCare
n=28 Participants
In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
|
|---|---|---|
|
Subjective Comfort Rating
|
82.5 Units on a scale
Interval 70.3 to 94.8
|
81.3 Units on a scale
Interval 64.9 to 97.8
|
Adverse Events
ClearCare First, Then Optifree Replenish
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Optifree Replenish First, Then ClearCare
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Craig A Woods, Research Manager
Centre for Contact Lens Research
Phone: 519-888-4567
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60