Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01341977
• Collaborator: (none)
• Enrollment: 573
• Location: 1
• Arms: 2
• Duration (Months): 5.9
• Patients Per Site Per Month: 96.4

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if Alcon MPDS is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.

Condition or Disease	Intervention/Treatment	Phase
Healthy Contact Lens Wearers	Device: Alcon MPDS; Device: ReNu Fresh MPS	N/A

Detailed Description

The purpose of this study is to determine if Alcon Multi-Purpose Disinfecting Solution (MPDS) is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.

Study Design

• Study Type: Interventional
• Actual Enrollment: 573 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution (MPDS)
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alcon MPDS Alcon Multi-Purpose Disinfecting Solution (MPDS)	Device: Alcon MPDS; Multi-Purpose Solution intended for use with silicone hydrogel and soft contact lenses; Other Names: Alcon Multi-Purpose Disinfecting Solution (MPDS)
Active Comparator: ReNu Fresh Multi-Purpose Solution ReNu Fresh Multi-Purpose Solution	Device: ReNu Fresh MPS; ReNu Fresh MPS is a marketed product indicated for cleaning, removing protein deposits, rinsing, disinfecting and storage of soft contact lenses.; Other Names: ReNu Fresh Multi-Purpose Solution (MPS)

Outcome Measures

Primary Outcome Measures

1. Subjective Acceptance [Day 90]

   Lens Moisture Subject Rated Likert Item (1-Strongly Agree to 5-Strongly Disagree)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Silicone hydrogel or soft contact lens wearers who wear their lenses daily wear (i.e. disinfect lenses every night).

• Patient must be able to read.

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

Exclusion Criteria:

• Sensitivity to multi-purpose solutions.

• Using any topical ocular OTC or prescribed topical ocular medications.

• History or current ocular infections or ocular inflammatory events.

• Ocular surgery within the past year.

• With a medical condition or using medications that cause ocular side effects.

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

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: Jessie M Lemp, MS, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01341977
• Other Study ID Numbers: C-09-026
• First Posted: Apr 26, 2011
• Last Update Posted: Sep 23, 2020
• Last Verified: Sep 1, 2011

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

Study Results

Participant Flow

Arm/Group Title	Alcon MPDS	ReNu Fresh Multi-Purpose Solution
Arm/Group Description	Alcon Multi-Purpose Disinfecting Solution (MPDS)	ReNu Fresh Multi-Purpose Solution (MPS)
Period Title: Overall Study
STARTED	288	285
COMPLETED	274	270
NOT COMPLETED	14	15

Baseline Characteristics

Arm/Group Title	Alcon MPDS	ReNu Fresh Multi-Purpose Solution	Total
Arm/Group Description	Alcon Multi-Purpose Disinfecting Solution (MPDS)	ReNu Fresh Multi-Purpose Solution (MPS)	Total of all reporting groups
Overall Participants	288	285	573
Age (Count of Participants)
<=18 years	8 2.8%	23 8.1%	31 5.4%
Between 18 and 65 years	279 96.9%	257 90.2%	536 93.5%
>=65 years	1 0.3%	5 1.8%	6 1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34 (10.7)	33.9 (11.4)	33.9 (11.0)
Sex: Female, Male (Count of Participants)
Female	214 74.3%	197 69.1%	411 71.7%
Male	74 25.7%	88 30.9%	162 28.3%
Region of Enrollment (participants) [Number]
United States	288 100%	285 100%	573 100%

Outcome Measures

1. Primary Outcome

Title	Subjective Acceptance
Description	Lens Moisture Subject Rated Likert Item (1-Strongly Agree to 5-Strongly Disagree)
Time Frame	Day 90

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alcon MPDS	ReNu Fresh Multi-Purpose Solution
Arm/Group Description	Alcon Multi-Purpose Disinfecting Solution (MPDS)	ReNu Fresh Multi-Purpose Solution (MPS)
Measure Participants	288	285
Mean (Standard Deviation) [units on a scale]	1.9 (.8)	2.1 (1.0)

Adverse Events

Time Frame	AE Forms document adverse events during study(occurring after exposure to test article), causality assessment performed by investigator/sponsor. A SAE Form completed & forwarded to Alcon/IRB/EC 24 hours of investigator's knowledge of event
Adverse Event Reporting Description	AE Forms document all AEs that occur during study (occurring after exposure to test article), causality assessment performed by investigator/sponsor. A SAE Form completed for all SAEs, forwarded to Alcon/IRB/EC within 24 hours of the investigator's knowledge of the event according to their requirements.
Arm/Group Title	Alcon MPDS		ReNu Fresh Multi-Purpose Solution
Arm/Group Description	Alcon Multi-Purpose Disinfecting Solution (MPDS)		ReNu Fresh Multi-Purpose Solution (MPS)
All Cause Mortality
	Alcon MPDS		ReNu Fresh Multi-Purpose Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Alcon MPDS		ReNu Fresh Multi-Purpose Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/288 (0%)		1/285 (0.4%)
Gastrointestinal disorders
Gastrointestinal Haemorrhage	0/288 (0%)	0	1/285 (0.4%)	1
Other (Not Including Serious) Adverse Events
	Alcon MPDS		ReNu Fresh Multi-Purpose Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/288 (0%)		0/285 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

All data and discoveries arising out of the Study shall be the sole property of Alcon or its designated affiliate. Alcon reserves the right of prior review of any publication or presentation of the information related to the Study.