Effect of an Investigational Multi-Purpose Solution on Lens Moisture

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01341990
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 33.9

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the effect of an investigational multi-purpose disinfecting solution (MPDS) compared to a marketed multi-purpose solution on the moisture of silicone hydrogel contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Contact Lens Moisture	Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS); Device: ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS); Device: Silicone Hydrogel Contact Lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Effect of SiH MPDS FID 114675A vs. a Marketed Multi-Purpose Solution on Lens Moisture
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FID 114675A Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses	Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS); Investigational solution intended for use as a cleaning, rinsing, reconditioning, disinfecting, and storage solution for silicone hydrogel and soft contact lenses; Device: Silicone Hydrogel Contact Lenses; Commercially marketed silicone hydrogel contact lenses per habitual prescription for daily wear use, at least 8 hours/day. New pair dispensed at Day 0 (Baseline Visit) and at the conclusion of Day 1 (Visit 2).; Other Names: Acuvue® Oasys™ PureVision®
Active Comparator: ReNu MultiPlus Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses	Device: ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS); Commercially marketed prodouct indicated for cleaning, removing protein deposits, rinsing, disinfecting, and storing soft contact lenses; Other Names: ReNu MultiPlus® Multi-Purpose Solution Fresh Lens Comfort™ ; Device: Silicone Hydrogel Contact Lenses; Commercially marketed silicone hydrogel contact lenses per habitual prescription for daily wear use, at least 8 hours/day. New pair dispensed at Day 0 (Baseline Visit) and at the conclusion of Day 1 (Visit 2).; Other Names: Acuvue® Oasys™ PureVision®

Outcome Measures

Primary Outcome Measures

1. Mean Ex-Vivo Advancing Contact Angle [Day 1, 8 hours]

   Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.

2. Mean Ex-Vivo Advancing Contact Angle [Day 8, 16 hours]

   Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• 18 years of age or older.

• Wears silicone hydrogel contact lenses on a daily wear basis i.e. disinfects lenses every night).

• Has successfully worn contact lenses for 5 days, 8 hours per day, prior to baseline visit.

• Vision is correctable to 20/30 or better in each eye at distance with study lenses at baseline visit.

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Known sensitivity or intolerance to contact lens multi-purpose solutions.

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

• History or current ocular infections or ocular inflammatory events.

• Ocular surgery within the past year.

• Medical condition or use of medication 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

• Study Director: Justin R Webb, OD, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01341990
• Other Study ID Numbers: C-09-031
• First Posted: Apr 26, 2011
• Last Update Posted: Apr 13, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by Alcon Research: Contact Lenses; Contact Lens Care; Multi-Purpose Solution
• Additional relevant MeSH terms: Pharmaceutical Solutions

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 1 US study center.

Arm/Group Title	FID 114675A	ReNu MultiPlus
Arm/Group Description	Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses	Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
Period Title: Overall Study
STARTED	35	33
COMPLETED	32	32
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	FID 114675A	ReNu MultiPlus	Total
Arm/Group Description	Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses	Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses	Total of all reporting groups
Overall Participants	35	33	68
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.9 (9.2)	42.8 (11.2)	43.4 (10.2)
Sex: Female, Male (Count of Participants)
Female	23 65.7%	22 66.7%	45 66.2%
Male	12 34.3%	11 33.3%	23 33.8%
Region of Enrollment (participants) [Number]
United States	35 100%	33 100%	68 100%

Outcome Measures

1. Primary Outcome

Title	Mean Ex-Vivo Advancing Contact Angle
Description	Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.
Time Frame	Day 1, 8 hours

Outcome Measure Data

Analysis Population Description

Intent to Treat.

Arm/Group Title	FID 114675A	ReNu MultiPlus
Arm/Group Description	Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses	Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
Measure Participants	34	32
Mean (Standard Deviation) [Degrees]	56.7 (21.2)	59.2 (23.7)

2. Primary Outcome

Title	Mean Ex-Vivo Advancing Contact Angle
Description	Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.
Time Frame	Day 8, 16 hours

Outcome Measure Data

Analysis Population Description

Intent to treat.

Arm/Group Title	FID 114675A	ReNu MultiPlus
Arm/Group Description	Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses	Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
Measure Participants	31	32
Mean (Standard Deviation) [Degrees]	59.5 (21.2)	63.4 (17.5)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study: 23 Nov 2009 to 27 Jan 2010.
Arm/Group Title	FID 114675A		ReNu MultiPlus
Arm/Group Description	Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses		Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
All Cause Mortality
	FID 114675A		ReNu MultiPlus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	FID 114675A		ReNu MultiPlus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	FID 114675A		ReNu MultiPlus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/33 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.