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

• ClinicalTrials.gov Identifier: NCT01996709
• Recruitment Status: Completed
• First Posted: November 27, 2013
• Results First Posted: June 8, 2015
• Last Update Posted: June 8, 2015
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: December 2013
• Actual Primary Completion Date: May 2014
• Actual Study Completion Date: May 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 Name: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Sponsors and Collaborators

Alcon Research

Investigators

• Study Director: Lisa Zoota, MPH; Alcon Research

More Information

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

Keywords provided by Alcon Research:

Silicone hydrogel contact lenses; Multi-purpose solution; Lid Papillae; Palpebral Roughness

Additional relevant MeSH terms:

Refractive Errors; Eye Diseases; Hydrogen Peroxide; Contact Lens Solutions; Pharmaceutical Solutions; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants