NCT00382603

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 in patients who experience discomfort with their contact lenses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
362

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
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 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:

  • Ocular Comfort and Symptom Scales

  • Subject Questions/Subject Likert Questionnaire

  • Safety:

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

  • Adverse Events

Secondary Outcomes (8)

  • Corneal Fluorescein Staining (Type and Area)

  • Lens Surface Evaluation (Lens Deposit and Lens Wettability)

  • Lens Replacement Incidence and Causality

  • Corrected Visual Acuity with Study Lenses (Snellen)

  • Rewetting Drop Frequency

  • +3 more secondary outcomes

Interventions

OptiFree Multi-Purpose Disinfecting SolutionDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic for contact lens related discomfort at the end of the lens wearing day.
  • Successful daily wear of FDA Group IV lenses on a two-week or longer replacement schedule for at least two weeks.
  • 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 4 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 confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Highlands Ranch

Highlands Ranch, Colorado, 80126, 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

September 29, 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)