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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 19, 2014