Trial Outcomes & Findings for Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers (NCT NCT01996709)
NCT ID: NCT01996709
Last Updated: 2015-06-08
Results Overview
Lid papillae (bumps on the inner eyelid) were assessed by the investigator using slit-lamp biomicroscopy and classified independently for the four palpebral zones (upper lid=1-3; lower lid=4) on a 5-point forced choice scale, where 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse \& tufts papillae); 3 = Moderate (moderate \& tufts papillae); 4 = Severe (giant papillae). The maximum of the four zones was selected for the analysis. Both eyes were included in the model for analysis. A higher change value indicates a larger reduction in the severity of the lid papillae.
COMPLETED
NA
142 participants
Baseline (Day 0), Day 90
2015-06-08
Participant Flow
Subjects were recruited from 12 study centers located in the US.
Of the 142 enrolled, 8 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (134).
Participant milestones
| Measure |
Clear Care
Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
|
Habitual MPS
Habitual contact lens solution used with habitual contact lenses for 90 days
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
68
|
|
Overall Study
COMPLETED
|
61
|
67
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
Clear Care
Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
|
Habitual MPS
Habitual contact lens solution used with habitual contact lenses for 90 days
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Subject Non-Compliant
|
1
|
0
|
|
Overall Study
Failed Inclusion/Exclusion Criteria
|
0
|
1
|
Baseline Characteristics
Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers
Baseline characteristics by cohort
| Measure |
Clear Care
n=66 Participants
Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
|
Habitual MPS
n=68 Participants
Habitual contact lens solution used with habitual contact lenses for 90 days
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.1 years
STANDARD_DEVIATION 11.55 • n=99 Participants
|
31.4 years
STANDARD_DEVIATION 7.65 • n=107 Participants
|
32.2 years
STANDARD_DEVIATION 9.76 • n=206 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Day 90Population: This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed. Here, "n" is subjects with non-missing values at the specific time point for each arm group, respectively.
Lid papillae (bumps on the inner eyelid) were assessed by the investigator using slit-lamp biomicroscopy and classified independently for the four palpebral zones (upper lid=1-3; lower lid=4) on a 5-point forced choice scale, where 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse \& tufts papillae); 3 = Moderate (moderate \& tufts papillae); 4 = Severe (giant papillae). The maximum of the four zones was selected for the analysis. Both eyes were included in the model for analysis. A higher change value indicates a larger reduction in the severity of the lid papillae.
Outcome measures
| Measure |
Clear Care, Right Eye
n=64 Participants
Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
|
Clear Care, Left Eye
n=64 Participants
Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
|
Habitual MPS, Right Eye
n=67 Participants
Habitual contact lens solution used with habitual contact lenses for 90 days
|
Habitual MPS, Left Eye
n=67 Participants
Habitual contact lens solution used with habitual contact lenses for 90 days
|
|---|---|---|---|---|
|
Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90
Baseline (Day 0)
|
2.3 units on a scale
Standard Deviation 0.54
|
2.3 units on a scale
Standard Deviation 0.62
|
2.2 units on a scale
Standard Deviation 0.54
|
2.2 units on a scale
Standard Deviation 0.54
|
|
Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90
Change from baseline at Day 90 (n=61, 61, 67, 67)
|
0.9 units on a scale
Standard Deviation 0.74
|
0.9 units on a scale
Standard Deviation 0.81
|
0.5 units on a scale
Standard Deviation 0.56
|
0.3 units on a scale
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: Day 90Population: This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.
As interpreted and reported by the subject on a questionnaire. A 5-point Likert scale was used, where 1=strongly disagree; 2=disagree; 3=undecided; 4=agree; 5=strongly agree. The Top-2-box response (agree, strongly agree) was calculated and reported as a percentage of all responses.
Outcome measures
| Measure |
Clear Care, Right Eye
n=61 Participants
Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
|
Clear Care, Left Eye
n=67 Participants
Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
|
Habitual MPS, Right Eye
Habitual contact lens solution used with habitual contact lenses for 90 days
|
Habitual MPS, Left Eye
Habitual contact lens solution used with habitual contact lenses for 90 days
|
|---|---|---|---|---|
|
Top 2 Box Percentage Agreement for "My Lenses Feel Like New" at Day 90
|
52.5 percentage of subjects
|
37.3 percentage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 90Population: This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.
As interpreted and reported by the subject on a questionnaire. The subject was asked, "During a typical day in the past 2 weeks, how often did your eyes feel gritty and/or scratchy while wearing your contact lenses?" and responded on a 5-point scale (1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Frequently; 5 = Constantly).
Outcome measures
| Measure |
Clear Care, Right Eye
n=61 Participants
Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
|
Clear Care, Left Eye
n=67 Participants
Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
|
Habitual MPS, Right Eye
Habitual contact lens solution used with habitual contact lenses for 90 days
|
Habitual MPS, Left Eye
Habitual contact lens solution used with habitual contact lenses for 90 days
|
|---|---|---|---|---|
|
Mean Frequency Score for Symptoms of Grittiness at Day 90
|
1.7 units on a scale
Standard Deviation 0.90
|
2.3 units on a scale
Standard Deviation 0.95
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 90Population: This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed. Here, "n" is subjects with non-missing values at the specific time point for each arm group, respectively.
As reported and interpreted by the subject on a questionnaire. The subject was asked "During a typical day in the past 2 weeks, how often did your eyes feel dry?" and responded on a 5-point scale ((0 = Never; 1 = Rarely; 2 = Sometimes; 3 = Frequently; 4 = Constantly).
Outcome measures
| Measure |
Clear Care, Right Eye
n=61 Participants
Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
|
Clear Care, Left Eye
n=67 Participants
Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
|
Habitual MPS, Right Eye
Habitual contact lens solution used with habitual contact lenses for 90 days
|
Habitual MPS, Left Eye
Habitual contact lens solution used with habitual contact lenses for 90 days
|
|---|---|---|---|---|
|
Mean Frequency Score for Symptoms of Dryness at Day 90
|
1.2 units on a scale
Standard Deviation 0.87
|
1.8 units on a scale
Standard Deviation 0.99
|
—
|
—
|
Adverse Events
Clear Care
Habitual MPS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jessie Lemp, DrPH, GMA Brand Lead
Alcon Research, Ltd.
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