NCT00383201

Brief Summary

To clinically evaluate the effect of a new multi-purpose disinfecting solution compared to a marketed multi-purpose solution on wettability of soft contact lenses worn for 30 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2005

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2006

Completed
Last Updated

August 16, 2012

Status Verified

September 1, 2006

Enrollment Period

6 months

First QC Date

September 28, 2006

Last Update Submit

August 15, 2012

Conditions

Contact Lens Care

Keywords

Contact Lens Care

Outcome Measures

Primary Outcomes (6)

  • Efficacy:

  • Contact lens wetting angle measured ex-vivo

  • Safety:

  • Slit-lamp Findings: Eyelids and Conjunctiva; Cornea; Iris, Anterior Chamber

  • Visual Acuity (Snellen)

  • Adverse Events

Interventions

OptiFree Multi-Purpose Disinfecting SolutionDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* Successful daily wear of FDA Group I or IV soft contact lenses for at least one week. * 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Fort Worth Site

Fort Worth, Texas, 76134, United States

Location

Study Officials

  • Leslie Napier

    Alcon Research

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 28, 2006

First Posted

October 2, 2006

Study Start

March 1, 2005

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

August 16, 2012

Record last verified: 2006-09

Locations

US(1)