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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01996709
First received: November 18, 2013
Last updated: May 26, 2015
Last verified: May 2015
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01996709

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01996709     History of Changes
Other Study ID Numbers: A01337
Study First Received: November 18, 2013
Results First Received: May 26, 2015
Last Updated: May 26, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Silicone hydrogel contact lenses
Multi-purpose solution
Lid Papillae
Palpebral Roughness

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases
Contact Lens Solutions
Hydrogen Peroxide
Pharmaceutical Solutions
Anti-Infective Agents
Anti-Infective Agents, Local
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2015