Effect of an Investigational Multi-Purpose Solution on Lens Moisture

NCT01341990 | Completed Results

• 1 other identifier: C-09-031
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Contact Lens Moisture

Keywords

Contact Lenses; Contact Lens Care; Multi-Purpose Solution

Outcome Measures

Primary Outcomes (2)

• Mean Ex-Vivo Advancing Contact Angle

  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.

  Day 1, 8 hours

• Mean Ex-Vivo Advancing Contact Angle

  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.

  Day 8, 16 hours

Study Arms (2)

FID 114675A

EXPERIMENTAL

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); Device: Silicone Hydrogel Contact Lenses

ReNu MultiPlus

ACTIVE COMPARATOR

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); Device: Silicone Hydrogel Contact Lenses

Interventions

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

Investigational solution intended for use as a cleaning, rinsing, reconditioning, disinfecting, and storage solution for silicone hydrogel and soft contact lenses

FID 114675A

ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS) DEVICE

Commercially marketed prodouct indicated for cleaning, removing protein deposits, rinsing, disinfecting, and storing soft contact lenses

Also known as: ReNu MultiPlus® Multi-Purpose Solution Fresh Lens Comfort™

ReNu MultiPlus

Silicone Hydrogel Contact Lenses DEVICE

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).

Also known as: Acuvue® Oasys™, PureVision®

FID 114675A; ReNu MultiPlus

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

Results Point of Contact

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

medinfo@alconlabs.com

1-888-451-3937

Study Officials

• Justin R Webb, OD

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: April 26, 2011
• Study Start: November 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: April 13, 2012
• Results First Posted: April 13, 2012

Record last verified: 2012-03

Locations

US (1)