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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01996709
First Posted: November 27, 2013
Last Update Posted: June 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  Purpose
The purpose of this study is to assess improvement of palpebral roughness and associated symptoms with 3 months use of Clear Care®.

Condition Intervention
Refractive Error Device: Hydrogen peroxide-based contact lens solution Device: Habitual contact lens solution Device: Habitual contact lenses

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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).

  • 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).


Enrollment: 142
Study Start Date: December 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996709


Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Lisa Zoota, MPH Alcon Research
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01996709     History of Changes
Other Study ID Numbers: A01337
First Submitted: November 18, 2013
First Posted: November 27, 2013
Results First Submitted: May 26, 2015
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
Pharmaceutical Solutions
Hydrogen Peroxide
Contact Lens Solutions
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants