Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01211535
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 51.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Myopia; Astigmatism; Refractive Error	Device: OPTI-FREE RepleniSH multipurpose solution; Device: ReNu Biotrue multipurpose solution; Device: Silicone hydrogel contact lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OPTI-FREE RepleniSH OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days	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; Other Names: OPTI-FREE® RepleniSH® ; Device: 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
Active Comparator: ReNu Biotrue ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days	Device: 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; Other Names: ReNu Biotrue™ ; Device: 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

Outcome Measures

Primary Outcome Measures

1. Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14 [Baseline (Day 0), 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Contact Alcon Trial Center for Trial Locations	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01211535
• Other Study ID Numbers: SMA-09-59
• First Posted: Sep 29, 2010
• Last Update Posted: Nov 12, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by Alcon Research: Soft contact lenses; Multi-purpose Solution
• Additional relevant MeSH terms: Astigmatism; Refractive Errors; Pharmaceutical Solutions

Study Results

Participant Flow

Arm/Group Title	OPTI-FREE RepleniSH	ReNu Biotrue
Arm/Group Description	OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days	ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
Period Title: Overall Study
STARTED	52	52
COMPLETED	52	51
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	OPTI-FREE RepleniSH	ReNu Biotrue	Total
Arm/Group Description	OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days	ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days	Total of all reporting groups
Overall Participants	52	52	104
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.3 (10.4)	35.4 (10.96)	34.3 (10.71)
Sex: Female, Male (Count of Participants)
Female	14 26.9%	10 19.2%	24 23.1%
Male	38 73.1%	42 80.8%	80 76.9%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14
Description	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.
Time Frame	Baseline (Day 0), Day 14

Outcome Measure Data

Analysis Population Description

All participants who received regimen, satisfied inclusion/exclusion criteria, and completed the 14-day treatment period (per protocol)

Arm/Group Title	OPTI-FREE RepleniSH	ReNu Biotrue
Arm/Group Description	OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days	ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
Measure Participants	52	51
Baseline (Day 0)	87.40	88.79
Day 14	81.75	83.18
Change from Baseline (Day 0) at Day 14	-5.65	-5.61

Adverse Events

Time Frame	Adverse events were collected for the duration of the study.
Adverse Event Reporting Description	The safety population includes all participants who received study regimen.
Arm/Group Title	OPTI-FREE RepleniSH		ReNu Biotrue
Arm/Group Description	OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days		ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
All Cause Mortality
	OPTI-FREE RepleniSH		ReNu Biotrue
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	OPTI-FREE RepleniSH		ReNu Biotrue
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/52 (0%)
Other (Not Including Serious) Adverse Events
	OPTI-FREE RepleniSH		ReNu Biotrue
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/52 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.