Refractive Error
Conditions
Keywords
Silicone hydrogel contact lenses, Multi-purpose solution, Lid Papillae, Palpebral Roughness
Brief summary
The purpose of this study is to assess improvement of palpebral roughness and associated symptoms with 3 months use of Clear Care®.
Interventions
DEVICEHydrogen peroxide-based contact lens solution
DEVICEHabitual contact lens solution
Biguanide-preserved
DEVICEHabitual contact lenses
Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Current biweekly or monthly silicone hydrogel contact lens wearer (excluding Air Optix® brand) and have worn these lenses bilaterally for at least three (3) months prior to Visit 1 (daily wear use only). * Symptoms of contact lens discomfort as defined by the protocol. * Habitual use of a biguanide-preserved multi-purpose solution for at least 30 days prior to Visit 1. * Mild to severe (grade 2-4) Investigator rated palpebral roughness in one or more zones of either eye. * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Extended (over-night) contact lens wearer. * Any systemic or ocular disease or disorder (refractive disorder allowed and mild dry eye with successful contact lens wear is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study. * Topical ocular over the counter (OTC) or prescribed medications, with the exception of contact lens rewetting drops, within 7 days of enrollment. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90 | Baseline (Day 0), Day 90 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Top 2 Box Percentage Agreement for My Lenses Feel Like New at Day 90 | Day 90 | 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. |
| Mean Frequency Score for Symptoms of Grittiness at Day 90 | Day 90 | 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). |
| Mean Frequency Score for Symptoms of Dryness at Day 90 | Day 90 | 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). |
Participant flow
Recruitment details
Subjects were recruited from 12 study centers located in the US.
Pre-assignment details
Of the 142 enrolled, 8 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (134).
Participants by arm
| Arm | Count |
|---|---|
| Clear Care Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days | 66 |
| Habitual MPS Habitual contact lens solution used with habitual contact lenses for 90 days | 68 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Failed Inclusion/Exclusion Criteria | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Subject Non-Compliant | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Clear Care | Habitual MPS | Total |
|---|---|---|---|
| Age, Continuous | 33.1 years STANDARD_DEVIATION 11.55 | 31.4 years STANDARD_DEVIATION 7.65 | 32.2 years STANDARD_DEVIATION 9.76 |
| Sex: Female, Male Female | 49 Participants | 55 Participants | 104 Participants |
| Sex: Female, Male Male | 17 Participants | 13 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 66 | 0 / 68 |
| serious Total, serious adverse events | 0 / 66 | 0 / 68 |
Outcome results
Primary
Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90
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.
Time frame: Baseline (Day 0), Day 90
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clear Care, Right Eye | 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 |
| Clear Care, Right Eye | 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 |
| Clear Care, Left Eye | 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 0.62 |
| Clear Care, Left Eye | 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 0.81 |
| Habitual MPS, Right Eye | Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90 | Baseline (Day 0) | 2.2 units on a scale | Standard Deviation 0.54 |
| Habitual MPS, Right Eye | 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) | 0.5 units on a scale | Standard Deviation 0.56 |
| Habitual MPS, Left Eye | 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) | 0.3 units on a scale | Standard Deviation 0.69 |
| Habitual MPS, Left Eye | Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90 | Baseline (Day 0) | 2.2 units on a scale | Standard Deviation 0.54 |
Secondary
Mean Frequency Score for Symptoms of Dryness at Day 90
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).
Time frame: Day 90
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clear Care, Right Eye | Mean Frequency Score for Symptoms of Dryness at Day 90 | 1.2 units on a scale | Standard Deviation 0.87 |
| Clear Care, Left Eye | Mean Frequency Score for Symptoms of Dryness at Day 90 | 1.8 units on a scale | Standard Deviation 0.99 |
Secondary
Mean Frequency Score for Symptoms of Grittiness at Day 90
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).
Time frame: Day 90
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clear Care, Right Eye | Mean Frequency Score for Symptoms of Grittiness at Day 90 | 1.7 units on a scale | Standard Deviation 0.9 |
| Clear Care, Left Eye | Mean Frequency Score for Symptoms of Grittiness at Day 90 | 2.3 units on a scale | Standard Deviation 0.95 |
Secondary
Top 2 Box Percentage Agreement for My Lenses Feel Like New at Day 90
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.
Time frame: Day 90
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clear Care, Right Eye | Top 2 Box Percentage Agreement for My Lenses Feel Like New at Day 90 | 52.5 percentage of subjects |
| Clear Care, Left Eye | Top 2 Box Percentage Agreement for My Lenses Feel Like New at Day 90 | 37.3 percentage of subjects |