A Multi-Center Investigation of Patient Acceptability of OPTI-FREE RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00772707
• Collaborator: (none)
• Enrollment: 114
• Location: 1
• Arm: 1
• Duration (Days): 30
• Patients Per Site Per Month: 115.7

Study Details

Study Description

Brief Summary

The purpose of this study was to demonstrate that current successful fulltime daily wear soft contact lens wearers using competitive multi-purpose solutions will note improved comfort when using OPTI-FREE RepleniSH®.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH); Device: Contact Lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 114 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A 30 Day, Multi-Centered, Open Label Study To Determine Comfort and Overall Contact Lens Wearing Experience Using OPTI-FREE RepleniSH® MPDS as Compared to COMPLETE®MPS Easy Rub™ or ReNu MultiPlus® in Daily Wear Soft Contact Lens Patients
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Opti-Free Replenish Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.	Device: Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH); OPTI-FREE RepleniSH® used according to product labeled instructions for cleaning and disinfecting study contact lenses, 30 days.; Other Names: OPTI-FREE RepleniSH® ; Device: Contact Lenses; Contact lenses per participant's habitual prescription removed nightly for cleaning and disinfecting.

Outcome Measures

Primary Outcome Measures

1. Comfort Ratings at Baseline [Baseline (Day 0)]

   Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with "Strongly Agree" or "Agree" for each question is presented.

2. Comfort Ratings at 30 Days [30 days]

   Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with "Strongly Agree" or "Agree" for each question is presented.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Participants must be between 18 and 65 years of age.

2. Must wear daily wear soft contact lenses a minimum of 8 hours per day,7 days a week.

3. Must be wearing a planned replacement soft lens in a 2 week or monthly replacement modality.

4. Must be using either COMPLETE Multi-Purpose Solution (MPS) Easy Rub or ReNu MultiPlus brand solution for at least 30 continuous days prior to enrollment.

5. Must be free of any contact lens-related symptoms with regard to comfort and vision throughout their wearing hours prior to enrollment, with the exception of end-of-day dryness not limiting all day wear.

6. Must have best corrected distance visual acuity, with contact lenses, of 20/30 or better in each eye.

7. Must be willing to maintain pre-enrollment systemic medication regimens during the study.

8. Must be willing to not use any topical medications or rewetting drops during the 30 day clinical trial duration.

9. Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

1. Has used any topical medication or rewetting drops for 7 days prior to enrollment.

2. Achieves best visual correction by monovision.

3. Has modified their systemic medications within 30 days prior to enrollment.

4. Has switched brands of cosmetics during the 30 days prior to the study.

5. Has a history of allergy to any study product ingredients.

6. Is unwilling or unable to meet the study visit timeline.

7. Has any active corneal, eyelid or other anterior segment inflammation or infection, which, in the opinion of the Investigator, would adversely affect successful contact lens wear.

8. Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Call 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: NCT00772707
• Other Study ID Numbers: SMA-08-14
• First Posted: Oct 15, 2008
• Last Update Posted: Sep 7, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by Alcon Research: contact lens solution; OPTI-FREE RepleniSH; contact lenses
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 6 US study sites.

Arm/Group Title	Opti-Free Replenish
Arm/Group Description	Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
Period Title: Overall Study
STARTED	114
COMPLETED	111
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Opti-Free Replenish
Arm/Group Description	Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
Overall Participants	114
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	36
Sex: Female, Male (Count of Participants)
Female	81 71.1%
Male	33 28.9%
Region of Enrollment (participants) [Number]
United States	114 100%

Outcome Measures

1. Primary Outcome

Title	Comfort Ratings at Baseline
Description	Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with "Strongly Agree" or "Agree" for each question is presented.
Time Frame	Baseline (Day 0)

Outcome Measure Data

Analysis Population Description

6 participants were excluded from analysis due to discontinuation of contact lens wear (1), treatment during study that might interfere with study outcome (1), withdrawal (3), and missing responses (1).

Arm/Group Title	Opti-Free Replenish
Arm/Group Description	Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
Measure Participants	108
My lens is comfortable upon instillation	86 75.4%
My lenses feel comfortable at the end of the day	59 51.8%
My vision is clear at the end of the day	57 50%
I am satisfied with my overall lens experience	81 71.1%

2. Primary Outcome

Title	Comfort Ratings at 30 Days
Description	Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with "Strongly Agree" or "Agree" for each question is presented.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

5 participants were excluded from analysis due to discontinuation of contact lens wear (1), treatment during study that might interfere with study outcome (1), and withdrawal (3).

Arm/Group Title	Opti-Free Replenish
Arm/Group Description	Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
Measure Participants	109
My lens is comfortable upon instillation	92 80.7%
My lenses feel comfortable at the end of the day	88 77.2%
My vision is clear at the end of the day	91 79.8%
I am satisfied with my overall lens experience	91 79.8%
Study product enhances wearing experience more	71 62.3%
I will continue to use the study solution after	81 71.1%

Adverse Events

Time Frame	Adverse events were collected for the duration of the study: 1 month, 12 days.
Adverse Event Reporting Description	The safety population included all enrolled and exposed participants.
Arm/Group Title	Opti-Free Replenish
Arm/Group Description	Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
All Cause Mortality
	Opti-Free Replenish
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Opti-Free Replenish
	Affected / at Risk (%)	# Events
Total	0/114 (0%)
Other (Not Including Serious) Adverse Events
	Opti-Free Replenish
	Affected / at Risk (%)	# Events
Total	0/114 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Alcon reserves the right of prior review of any publication or presentation of information related to the study.