San Diego, California, United States
NCT Number: NCT00691197
Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear
Testing the Safety and Acceptability of Using a Rewetting Drop with Contact Lenses
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2 / Phase 3
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Adapted contact lens wearer
Exclusion criteria
- Monovision lens wearer, ocular or systemic disease, pregnant or planning to become pregnant
Treatment and study plan
Carboxymethylcellulose sodium and Glycerin
DeviceEye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.
Other names: Optive™
Carboxymethylcellulose sodium
DeviceEye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.
Other names: Refresh Contacts®
Primary outcomes
-
Best Corrected Visual Acuity
Time frame: Change from Baseline at Day 90
Percentage of Subjects Tabulated by Changes in Line Number at Day 90 from Baseline; Visual Acuity measured by LogMar reported as Snellen equivalents. Better: an increase of 2 lines or more in at least one eye; No Change: a change less than +/- 2 lines in both eyes; Worse: a decrease of 2 lines or more in at least one eye.
Secondary outcomes
-
Corneal Staining
Time frame: Day 90
Corneal staining of greater or equal to grade 2 at day 90. Grading scale: 0 = None Present; 1 = Trace Finding; 2 = Mild Finding; 3 = Moderate Finding; 4 = Severe Finding
Sponsors and collaborators
Lead sponsor
Allergan
Industry
Registry information
Important dates
- Study start
- 2008
- Primary completion
- 2008
- Study completion
- 2008
- First posted
- Jun 5, 2008
- Registry last updated
- Jul 22, 2015
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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