Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers

NCT01211535 | Completed Results

• 1 other identifier: SMA-09-59
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to assess the comfort of OPTI-FREE RepleniSH in soft contact lens wearers.

Conditions

Myopia; Astigmatism; Refractive Error

Keywords

Soft contact lenses; Multi-purpose Solution

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14

  Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described, "how your eyes feel right now." A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort.

  Baseline (Day 0), Day 14

Study Arms (2)

OPTI-FREE RepleniSH

EXPERIMENTAL

OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days

Device: OPTI-FREE RepleniSH multipurpose solution; Device: Silicone hydrogel contact lenses

ReNu Biotrue

ACTIVE COMPARATOR

ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days

Device: ReNu Biotrue multipurpose solution; Device: Silicone hydrogel contact lenses

Interventions

OPTI-FREE RepleniSH multipurpose solution DEVICE

FDA-approved, multipurpose solution used as indicated for cleaning, rinsing, conditioning, disinfecting, and storing study contact lenses on a daily wear basis for 14 days

Also known as: OPTI-FREE® RepleniSH®

OPTI-FREE RepleniSH

ReNu Biotrue multipurpose solution DEVICE

FDA-approved, multipurpose solution used as indicated for cleaning, disinfecting, daily protein removing, and storing study contact lenses on a daily wear basis for 14 days

Also known as: ReNu Biotrue™

ReNu Biotrue

Silicone hydrogel contact lenses DEVICE

Silicone hydrogel contact lenses per subject's habitual brand and prescription worn on a daily wear basis for 14 days, with either OPTI-FREE RepleniSH or ReNu Biotrue used for contact lens care

OPTI-FREE RepleniSH; ReNu Biotrue

Eligibility Criteria

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

You may qualify if:

• Currently wearing silicone hydrogel contact lenses on a daily wear basis;
• Currently using OPTI-FREE RepleniSH contact lens solution;
• Generally healthy;
• Normal ocular health;
• Willing to follow study procedures and visit schedule;
• Sign Informed Consent and privacy document;

You may not qualify if:

• Use of additional lens cleaners;
• Known sensitivities to any ingredient in either test article;
• Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study;
• History of ocular surgery/trauma within the last 6 months;
• Any topical ocular or systemic antibiotics within 7 days of enrollment continuing throughout the study;
• Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollent;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Trial Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Myopia; Astigmatism; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Jami Kern, Ph.D.
• Organization: Alcon Global Medical Affairs

1-888-451-3937

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: September 29, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 12, 2012
• Results First Posted: November 12, 2012

Record last verified: 2012-10

Locations

US (1)