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OpenTrials
Completed

NCT Number: NCT01996709

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

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

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Key information

Conditions

Refractive Error Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydrogen peroxide-based contact lens solution

Device

Other names: Clear Care®

Habitual contact lens solution

Device

Biguanide-preserved

Habitual Contact Lenses

Device

Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 27, 2013
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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