Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers

Myopia Clinical Trial

Official title:

Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211535
• Other study ID #: SMA-09-59
• Status: Completed
• Phase: N/A
• First received: September 28, 2010
• Last updated: October 15, 2012
• Start date: September 2010
• Est. completion date: November 2010

Study information

• Verified date: October 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• 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;

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Astigmatism
• Myopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• OPTI-FREE RepleniSH multipurpose solution
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
• ReNu Biotrue multipurpose solution
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
• Silicone hydrogel contact lenses
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

Locations

Country	Name	City	State
United States	Contact Alcon Trial Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No