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

NCT01996709 | Completed Results

• 1 other identifier: A01337
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Refractive Error

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Top 2 Box Percentage Agreement for "My Lenses Feel Like New" at Day 90

  Day 90

• Mean Frequency Score for Symptoms of Grittiness at Day 90

  Day 90

• Mean Frequency Score for Symptoms of Dryness at Day 90

  Day 90

Study Arms (2)

Clear Care

EXPERIMENTAL

Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days

Device: Hydrogen peroxide-based contact lens solution; Device: Habitual contact lenses

Habitual MPS

ACTIVE COMPARATOR

Habitual contact lens solution used with habitual contact lenses for 90 days

Device: Habitual contact lens solution; Device: Habitual contact lenses

Interventions

Hydrogen peroxide-based contact lens solution DEVICE

Also known as: Clear Care®

Clear Care

Habitual contact lens solution DEVICE

Biguanide-preserved

Habitual MPS

Habitual contact lenses DEVICE

Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule

Clear Care; Habitual MPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Jessie Lemp, DrPH, GMA Brand Lead
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Lisa Zoota, MPH

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 27, 2013
• Study Start: December 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 8, 2015
• Results First Posted: June 8, 2015

Record last verified: 2015-05