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OpenTrials
Completed

NCT Number: NCT00382603

Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Soft Contact Lenses in Symptomatic Patients

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.

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Key information

Conditions

Contact Lens Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Highlands Ranch

Highlands Ranch, Colorado, 80126, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

OptiFree Multi-Purpose Disinfecting Solution

Device

Primary outcomes

  1. Efficacy:

  2. Ocular Comfort and Symptom Scales

  3. Subject Questions/Subject Likert Questionnaire

  4. Safety:

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

  6. Adverse Events

Secondary outcomes

  1. Corneal Fluorescein Staining (Type and Area)

  2. Lens Surface Evaluation (Lens Deposit and Lens Wettability)

  3. Lens Replacement Incidence and Causality

  4. Corrected Visual Acuity with Study Lenses (Snellen)

  5. Rewetting Drop Frequency

  6. Lens Removal Frequency

  7. Average Lens Wearing Time

  8. Average Uncomfortable Lens Wearing Time

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Clinical Evaluation of the Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution Compared to a Marketed Multi-Purpose Solution for Care of Soft Contact Lenses in Symptomatic Patients

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 29, 2006
Registry last updated
Aug 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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