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

NCT01187355 | Completed Results

• 1 other identifier: C-09-074
• Study Type: interventional
• Target: 591
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Symptomatic Contact Lens Wearers

Keywords

Symptomatic, Contact lens care; Multi-purpose solution

Outcome Measures

Primary Outcomes (1)

• Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses.

  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.

  Day 30

Secondary Outcomes (2)

• Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening.

  Day 30

• Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses.

  Day 30

Study Arms (2)

Alcon MPDS

EXPERIMENTAL

MPDS used for 30 days as specified in protocol for contact lens care.

Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS); Device: Contact lenses

renu fresh MPS

ACTIVE COMPARATOR

MPS used for 30 days as indicated for contact lens care.

Device: renu fresh Multi-Purpose Solution (MPS); Device: Contact lenses

Interventions

FID 114675A Multi-Purpose Disinfecting Solution (MPDS) DEVICE

Investigational multi-purpose disinfecting solution used by subjects as specified in use instructions provided for the care of study contact lenses, 30 days.

Alcon MPDS

renu fresh Multi-Purpose Solution (MPS) DEVICE

Commercially available multi-purpose solution used by subjects as indicated for care of study contact lenses, 30 days.

Also known as: renu® fresh™ Multi-Purpose Solution

renu fresh MPS

Contact lenses DEVICE

Contact lenses per subject's habitual brand and power worn for 30 days on a daily wear basis.

Alcon MPDS; renu fresh MPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Interventions

Contact Lenses

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Director of Alcon Clinical
• Organization: Alcon Research, Ltd.

medinfo@alconlabs.com

1-888-451-3937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2010
• First Posted: August 24, 2010
• Study Start: July 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: July 30, 2012
• Results First Posted: July 30, 2012

Record last verified: 2012-06

Locations

US (1)