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

Refractive Error Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01996709
• Other study ID #: A01337
• Status: Completed
• Phase: N/A
• First received: November 18, 2013
• Last updated: May 26, 2015
• Start date: December 2013
• Est. completion date: May 2014

Study information

• Verified date: May 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Hydrogen peroxide-based contact lens solution

• Habitual contact lens solution
Biguanide-preserved
• Habitual contact lenses
Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline (Day 0), Day 90	No
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.	Day 90	No
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).	Day 90	No
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).	Day 90	No