Alcon Multi-Purpose Disinfecting Solution Versus Renu Fresh Multi-Purpose Solution in Symptomatic Contact Lens Wearers

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01187355
• Collaborator: (none)
• Enrollment: 591
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 97.8

Study Details

Study Description

Brief Summary

The purpose of this study is to compare two contact lens care solutions in symptomatic wearers of silicone hydrogel contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Symptomatic Contact Lens Wearers	Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS); Device: renu fresh Multi-Purpose Solution (MPS); Device: Contact lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 591 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: SiH MPDS FID 114675A Compared to Renu Fresh MPS in Symptomatic Contact Lens Wearers
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alcon MPDS MPDS used for 30 days as specified in protocol for contact lens care.	Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS); Investigational multi-purpose disinfecting solution used by subjects as specified in use instructions provided for the care of study contact lenses, 30 days.; Device: Contact lenses; Contact lenses per subject's habitual brand and power worn for 30 days on a daily wear basis.
Active Comparator: renu fresh MPS MPS used for 30 days as indicated for contact lens care.	Device: renu fresh Multi-Purpose Solution (MPS); Commercially available multi-purpose solution used by subjects as indicated for care of study contact lenses, 30 days.; Other Names: renu® fresh™ Multi-Purpose Solution ; Device: Contact lenses; Contact lenses per subject's habitual brand and power worn for 30 days on a daily wear basis.

Outcome Measures

Primary Outcome Measures

1. Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses. [Day 30]

   As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.

Secondary Outcome Measures

1. Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening. [Day 30]

   As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.

2. Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses. [Day 30]

   As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Symptomatic silicone hydrogel contact lens wearers who wear their lenses daily wear (i.e., disinfect lenses every night).

• Vision correctable to 20/30 or better with contact lenses.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Sensitivity to multi-purpose solutions.

• Use of any topical ocular OTC or prescribed topical ocular medications.

• History (6 months) or current ocular infections or ocular inflammatory events.

• Ocular surgery within the past year.

• Medical condition or use of medications that cause ocular side effects.

• Participation in any investigational study within the past 30 days.

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Contact 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: NCT01187355
• Other Study ID Numbers: C-09-074
• First Posted: Aug 24, 2010
• Last Update Posted: Jul 30, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by Alcon Research: Symptomatic, Contact lens care; Multi-purpose solution
• Additional relevant MeSH terms: Pharmaceutical Solutions

Study Results

Participant Flow

Recruitment Details	Subjects were recruited and enrolled from 42 US study centers.
Pre-assignment Detail	The Participant Flow Chart includes all randomized patients: 591. Baseline characteristics are presented for all subjects who received test article and had at least one on-regimen study visit: 578.

Arm/Group Title	Alcon MPDS	Renu Fresh MPS
Arm/Group Description	Multi-purpose disinfecting contact lens solution	Multi-purpose contact lens solution
Period Title: Overall Study
STARTED	294	297
COMPLETED	276	277
NOT COMPLETED	18	20

Baseline Characteristics

Arm/Group Title	Alcon MPDS	Renu Fresh MPS	Total
Arm/Group Description	Multi-purpose disinfecting contact lens solution	Multi-purpose contact lens solution	Total of all reporting groups
Overall Participants	288	290	578
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.5 (11.43)	34.0 (11.24)	34.3 (11.33)
Sex: Female, Male (Count of Participants)
Female	209 72.6%	212 73.1%	421 72.8%
Male	79 27.4%	78 26.9%	157 27.2%

Outcome Measures

1. Primary Outcome

Title	Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses.
Description	As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed subjects with an on-regimen follow-up visit.

Arm/Group Title	Alcon MPDS	Renu Fresh MPS
Arm/Group Description	Multi-purpose disinfecting contact lens solution	Multi-purpose contact lens solution
Measure Participants	276	277
Mean (Standard Deviation) [Units on a scale]	3.9 (0.92)	3.8 (1.05)

2. Secondary Outcome

Title	Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening.
Description	As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed subjects with an on-regimen follow-up visit.

Arm/Group Title	Alcon MPDS	Renu Fresh MPS
Arm/Group Description	Multi-purpose disinfecting contact lens solution	Multi-purpose contact lens solution
Measure Participants	276	276
Mean (Standard Deviation) [Units on a scale]	3.3 (1.12)	3.2 (1.21)

3. Secondary Outcome

Title	Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses.
Description	As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed subjects with an on-regimen follow-up visit.

Arm/Group Title	Alcon MPDS	Renu Fresh MPS
Arm/Group Description	Multi-purpose disinfecting contact lens solution	Multi-purpose contact lens solution
Measure Participants	276	277
Mean (Standard Deviation) [Units on a scale]	3.2 (1.13)	3.1 (1.15)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study: 5 months, 2 weeks, 1 day.
Adverse Event Reporting Description	This reporting group includes all subjects enrolled and dispensed test article.
Arm/Group Title	Alcon MPDS		Renu Fresh MPS
Arm/Group Description	Multi-purpose disinfecting contact lens solution		Multi-purpose contact lens solution
All Cause Mortality
	Alcon MPDS		Renu Fresh MPS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Alcon MPDS		Renu Fresh MPS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/292 (0.3%)		1/297 (0.3%)
Psychiatric disorders
Schizoaffective Disorder Bipolar Type	1/292 (0.3%)	1	0/297 (0%)	0
Reproductive system and breast disorders
Abortion Spontaneous	0/292 (0%)	0	1/297 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Alcon MPDS		Renu Fresh MPS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/292 (0%)		0/297 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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