Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01996709
• Collaborator: (none)
• Enrollment: 142
• Arms: 2
• Duration (Months): 5

Study Details

Study Description

Brief Summary

The purpose of this study is to assess improvement of palpebral roughness and associated symptoms with 3 months use of Clear Care®.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error	Device: Hydrogen peroxide-based contact lens solution; Device: Habitual contact lens solution; Device: Habitual contact lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 142 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Supportive Care
• Official Title: Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Clear Care Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days	Device: Hydrogen peroxide-based contact lens solution; Other Names: Clear Care® ; Device: Habitual contact lenses; Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule
Active Comparator: Habitual MPS Habitual contact lens solution used with habitual contact lenses for 90 days	Device: Habitual contact lens solution; Biguanide-preserved; Device: Habitual contact lenses; Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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).

3. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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 exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Lisa Zoota, MPH, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01996709
• Other Study ID Numbers: A01337
• First Posted: Nov 27, 2013
• Last Update Posted: Jun 8, 2015
• Last Verified: May 1, 2015

• Keywords provided by Alcon Research: Silicone hydrogel contact lenses; Multi-purpose solution; Lid Papillae; Palpebral Roughness
• Additional relevant MeSH terms: Refractive Errors; Hydrogen Peroxide; Contact Lens Solutions; Pharmaceutical Solutions

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 12 study centers located in the US.
Pre-assignment Detail	Of the 142 enrolled, 8 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (134).

Arm/Group Title	Clear Care	Habitual MPS
Arm/Group Description	Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days	Habitual contact lens solution used with habitual contact lenses for 90 days
Period Title: Overall Study
STARTED	66	68
COMPLETED	61	67
NOT COMPLETED	5	1

Baseline Characteristics

Arm/Group Title	Clear Care	Habitual MPS	Total
Arm/Group Description	Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days	Habitual contact lens solution used with habitual contact lenses for 90 days	Total of all reporting groups
Overall Participants	66	68	134
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.1 (11.55)	31.4 (7.65)	32.2 (9.76)
Sex: Female, Male (Count of Participants)
Female	49 74.2%	55 80.9%	104 77.6%
Male	17 25.8%	13 19.1%	30 22.4%

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Clear Care, Right Eye	Clear Care, Left Eye	Habitual MPS, Right Eye	Habitual MPS, Left Eye
Arm/Group Description	Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days	Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days	Habitual contact lens solution used with habitual contact lenses for 90 days	Habitual contact lens solution used with habitual contact lenses for 90 days
Measure Participants	64	64	67	67
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)

2. Secondary Outcome

Title	Top 2 Box Percentage Agreement for "My Lenses Feel Like New" at Day 90
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Clear Care	Habitual MPS
Arm/Group Description	Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days	Habitual contact lens solution used with habitual contact lenses for 90 days
Measure Participants	61	67
Number [percentage of subjects]	52.5	37.3

3. Secondary Outcome

Title	Mean Frequency Score for Symptoms of Grittiness at Day 90
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Clear Care	Habitual MPS
Arm/Group Description	Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days	Habitual contact lens solution used with habitual contact lenses for 90 days
Measure Participants	61	67
Mean (Standard Deviation) [units on a scale]	1.7 (0.90)	2.3 (0.95)

4. Secondary Outcome

Title	Mean Frequency Score for Symptoms of Dryness at Day 90
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Clear Care	Habitual MPS
Arm/Group Description	Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days	Habitual contact lens solution used with habitual contact lenses for 90 days
Measure Participants	61	67
Mean (Standard Deviation) [units on a scale]	1.2 (0.87)	1.8 (0.99)

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	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 medical device.
Arm/Group Title	Clear Care		Habitual MPS
Arm/Group Description	Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days		Habitual contact lens solution used with habitual contact lenses for 90 days
All Cause Mortality
	Clear Care		Habitual MPS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Clear Care		Habitual MPS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		0/68 (0%)
Other (Not Including Serious) Adverse Events
	Clear Care		Habitual MPS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		0/68 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.