An interventional study of Hydrogen peroxide-based contact lens solution and Habitual contact lens solution in Refractive Error, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-08.
Sponsored by Alcon Research · Not applicable, Interventional, and Supportive care
The purpose of this study is to assess improvement of palpebral roughness and associated symptoms with 3 months use of Clear Care®.
413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.
This study's enrollment of 142 is above the median of 82 across 296 interventional studies indexed under Refractive Errors.
Browse Refractive Errors studies →Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.
Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
Device: Hydrogen peroxide-based contact lens solution · Device: Habitual contact lenses
Habitual contact lens solution used with habitual contact lenses for 90 days
Device: Habitual contact lens solution · Device: Habitual contact lenses
Also known as: Clear Care®
Biguanide-preserved
Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule
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
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
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
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
Subjects were recruited from 12 study centers located in the US.
| Milestone | Clear Care | Habitual MPS |
|---|---|---|
| Started | 66 | 68 |
| Completed | 61 | 67 |
| Not completed | 5 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Lost to follow-up | 3 | 0 |
| Withdrew: Subject non-compliant | 1 | 0 |
| Withdrew: Failed inclusion/exclusion criteria | 0 | 1 |
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.
| units on a scale | Clear Care, Right Eye | Clear Care, Left Eye | Habitual MPS, Right Eye | Habitual MPS, Left Eye |
|---|---|---|---|---|
| Baseline (Day 0) | 2.3 ± 0.54 | 2.3 ± 0.62 | 2.2 ± 0.54 | 2.2 ± 0.54 |
| Change from baseline at Day 90 (n=61, 61, 67, 67) | 0.9 ± 0.74 | 0.9 ± 0.81 | 0.5 ± 0.56 | 0.3 ± 0.69 |
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.
| percentage of subjects | Clear Care | Habitual MPS |
|---|---|---|
| Top 2 Box Percentage Agreement for "My Lenses Feel Like New" at Day 90 | 52.5 | 37.3 |
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).
| units on a scale | Clear Care | Habitual MPS |
|---|---|---|
| Mean Frequency Score for Symptoms of Grittiness at Day 90 | 1.7 ± 0.90 | 2.3 ± 0.95 |
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).
| units on a scale | Clear Care | Habitual MPS |
|---|---|---|
| Mean Frequency Score for Symptoms of Dryness at Day 90 | 1.2 ± 0.87 | 1.8 ± 0.99 |
Collected over Adverse events (AEs) were collected for the duration of the study (DEC 2013 - MAY 2014). This analysis group includes all subjects who were exposed to a study regimen.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Clear Care | — | 0/66 (0%) | 0/66 (0%) |
| Habitual MPS | — | 0/68 (0%) | 0/68 (0%) |
This analysis group includes all subjects who were exposed to a study regimen.
| Age, Continuous(years) | Clear Care | Habitual MPS | Total |
|---|---|---|---|
| Mean | 33.1 ± 11.55 | 31.4 ± 7.65 | 32.2 ± 9.76 |
| Sex: Female, Male(Participants) | Clear Care | Habitual MPS | Total |
|---|---|---|---|
| Female | 49 | 55 | 104 |
| Male | 17 | 13 | 30 |
No study locations are listed for this record.
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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