NCT00382681

Brief Summary

The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2004

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
Last Updated

February 2, 2012

Status Verified

February 1, 2012

Enrollment Period

4 months

First QC Date

September 28, 2006

Last Update Submit

February 1, 2012

Conditions

Contact Lens Care

Keywords

Contact Lens Care

Outcome Measures

Primary Outcomes (1)

  • Lens Cleanliness - Residual lens lysozyme (HPLC) at Day 90 on Group IV lenses

    Day 90

Secondary Outcomes (1)

  • Average Lens Wearing Time

    Day 90

Study Arms (2)

FID 107027

EXPERIMENTAL

Contact lens solution used as instructed for 90 days.

Device: FID 107027 Multi-Purpose Disinfecting Solution

ReNu MultiPlus

ACTIVE COMPARATOR

Contact lens solution used as instructed for 90 days.

Device: ReNu MultiPlus Multi-Purpose Solution No Rub Formula

Interventions

FID 107027 Multi-Purpose Disinfecting SolutionDEVICE

Investigational, multi-purpose disinfecting solution intended for use in cleaning, rinsing, conditioning, disinfecting, and storing soft contact lenses.

FID 107027
ReNu MultiPlus Multi-Purpose Solution No Rub FormulaDEVICE

Commercially marketed product indicated for cleaning, rinsing, disinfecting, and storing soft contact lenses.

ReNu MultiPlus

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Successful daily wear of FDA Group I or IV lenses on a two-week or longer replacement schedule for at least one month.
  • Use of a multi-purpose solution only as the pre-study care regimen for at least one month (rewetting drops use is also acceptable).
  • Successful lens wear for at least 8 hours per day.
  • Vision correctable to 20/30.
  • Normal eyes - no current ocular abnormalities that prevent successful contact lens wear.
  • No corneal surgery within the past 12 months.
  • No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions.
  • No over-the-counter or prescription ocular medication.
  • No enrollment in another clinical study within 30 days prior to enrollment.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elkin

Elkin, North Carolina, 28621, United States

Location

Study Officials

  • Leslie Napier

    Alcon Research

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 28, 2006

First Posted

September 29, 2006

Study Start

July 1, 2004

Primary Completion

November 1, 2004

Study Completion

November 1, 2004

Last Updated

February 2, 2012

Record last verified: 2012-02

Locations

US(1)