Back to resultsSafety and Acceptability of Using a Rewetting Drop With Contact Lens Wear
Primary Purpose
Ametropia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Carboxymethylcellulose sodium and Glycerin
Carboxymethylcellulose sodium
Sponsored by
About this trial
This is an interventional treatment trial for Ametropia
Eligibility Criteria
Inclusion Criteria:
- Adapted contact lens wearer
Exclusion Criteria:
- Monovision lens wearer, ocular or systemic disease, pregnant or planning to become pregnant
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Carboxymethylcellulose sodium and Glycerin
Carboxymethylcellulose sodium
Arm Description
Carboxymethylcellulose sodium and Glycerin based rewetting drop
Carboxymethylcellulose sodium based rewetting drop
Outcomes
Primary Outcome Measures
Best Corrected Visual Acuity
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 Outcome Measures
Corneal Staining
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00691197
Brief Title
Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear
Official Title
Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Testing the Safety and Acceptability of Using a Rewetting Drop with Contact Lenses
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ametropia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
246 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carboxymethylcellulose sodium and Glycerin
Arm Type
Experimental
Arm Description
Carboxymethylcellulose sodium and Glycerin based rewetting drop
Arm Title
Carboxymethylcellulose sodium
Arm Type
Active Comparator
Arm Description
Carboxymethylcellulose sodium based rewetting drop
Intervention Type
Device
Intervention Name(s)
Carboxymethylcellulose sodium and Glycerin
Other Intervention Name(s)
Optive™
Intervention Description
Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.
Intervention Type
Device
Intervention Name(s)
Carboxymethylcellulose sodium
Other Intervention Name(s)
Refresh Contacts®
Intervention Description
Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity
Description
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.
Time Frame
Change from Baseline at Day 90
Secondary Outcome Measure Information:
Title
Corneal Staining
Description
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
Time Frame
Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adapted contact lens wearer
Exclusion Criteria:
Monovision lens wearer, ocular or systemic disease, pregnant or planning to become pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Chair
Facility Information:
City
San Diego
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear
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