Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Soft Contact Lenses in Symptomatic Patients
This study has been completed.
Information provided by (Responsible Party):
First received: September 28, 2006
Last updated: August 15, 2012
Last verified: September 2006
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.
Contact Lens Care
Device: OptiFree Multi-Purpose Disinfecting Solution
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Ocular Comfort and Symptom Scales
- Subject Questions/Subject Likert Questionnaire
- Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications
- Adverse Events
Secondary Outcome Measures:
- 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
- Lens Removal Frequency
- Average Lens Wearing Time
- Average Uncomfortable Lens Wearing Time
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2005 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382603
|Highlands Ranch, Colorado, United States, 80126 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 28, 2006
||August 15, 2012
||United States: Institutional Review Board
Keywords provided by Alcon Research:
ClinicalTrials.gov processed this record on December 05, 2013