NCT00382902

Brief Summary

The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution in patients wearing silicone hydrogel soft contact lenses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
233

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 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

August 1, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
1.7 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 (12)

  • Corneal Fluorescein Staining (Type and Area)

  • Conjunctival Staining

  • Lens Deposits

  • Subject Questions/Subject Likert Questionnaire

  • Ocular Comfort and Symptom Scales

  • Lens Replacement Incidence and Causality

  • Corrected Visual Acuity with Study Lenses (Snellen)

  • Average Lens Wearing Time

  • Average Uncomfortable Lens Wearing Time

  • Safety:

  • Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications

  • 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 Night \& Day® or Acuvue® Advance™ silicone hydrogel contact for at least two weeks. * Use of AOSEPT® ClearCare™ only as the pre-study care regimen for at least two weeks (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.

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

Sponsors & Collaborators

Study Sites (1)

Portland Site

Portland, Maine, 04101, 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

August 1, 2004

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

August 16, 2012

Record last verified: 2006-09

Locations

US(1)