Effect of Multi-Purpose Solutions on Ex-Vivo Wetting Angles
Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00383201
Collaborator
(none)
80
1
6
13.2
Study Details
Study Description
Brief Summary
To clinically evaluate the effect of a new multi-purpose disinfecting solution compared to a marketed multi-purpose solution on wettability of soft contact lenses worn for 30 days.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Long-Term Effect of Multi-Purpose Solutions on Ex-Vivo Wetting Angles of Soft Contact Lenses
Study Start Date
:
Mar 1, 2005
Actual Primary Completion Date
:
Sep 1, 2005
Actual Study Completion Date
:
Sep 1, 2005
Outcome Measures
Primary Outcome Measures
- Efficacy: []
- Contact lens wetting angle measured ex-vivo []
- Safety: []
- Slit-lamp Findings: Eyelids and Conjunctiva; Cornea; Iris, Anterior Chamber []
- Visual Acuity (Snellen) []
- Adverse Events []
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
-
Successful daily wear of FDA Group I or IV soft contact lenses for at least one week.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fort Worth Site | Fort Worth | Texas | United States | 76134 |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Leslie Napier, Alcon Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00383201
Other Study ID Numbers:
- C-05-01
First Posted:
Oct 2, 2006
Last Update Posted:
Aug 16, 2012
Last Verified:
Sep 1, 2006
Keywords provided by Alcon Research