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OpenTrials
Completed

NCT Number: NCT00382902

Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Silicone Hydrogel Soft Contact Lenses

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.

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Key information

Conditions

Contact Lens Care

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Portland Site

Portland, Maine, 04101, United States

Who can participate

Healthy volunteers accepted: Yes

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

  • 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.

Treatment and study plan

OptiFree Multi-Purpose Disinfecting Solution

Device

Primary outcomes

  1. Corneal Fluorescein Staining (Type and Area)

  2. Conjunctival Staining

  3. Lens Deposits

  4. Subject Questions/Subject Likert Questionnaire

  5. Ocular Comfort and Symptom Scales

  6. Lens Replacement Incidence and Causality

  7. Corrected Visual Acuity with Study Lenses (Snellen)

  8. Average Lens Wearing Time

  9. Average Uncomfortable Lens Wearing Time

  10. Safety:

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

  12. Adverse Events

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 Two Marketed Multi-Purpose Solutions for Care of Silicone Hydrogel Soft Contact Lenses

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Oct 2, 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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