Safety and Tolerability of Artificial Tears in Dry Eye Subjects
1 other identifier
interventional
47
1 country
1
Brief Summary
The safety and tolerability of two new artificial tears will be compared to a currently-available artificial tear in subjects with dry eye. Each subject will receive all three products in a randomly assigned order. The subject will use one product at a time for a duration of one week before switching to the next assigned product.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2009
CompletedFirst Posted
Study publicly available on registry
July 3, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
December 13, 2011
CompletedAugust 26, 2015
August 1, 2015
1 month
July 1, 2009
November 9, 2011
August 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Tolerability Questionnaire Mean Scores at 1 Week
Tolerability Questionnaire mean scores at 1 week. The Tolerability Questionnaire includes 8 tolerability questions on selected performance measures. All questions are scored based on continuous visual analog scale from 0-100. The first 4 questions presented measure increasing tolerability where 0=worst and 100=best. The second set of 4 questions presented measure decreasing tolerability where 0=best and 100=worst.
1 Week
Secondary Outcomes (3)
Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week
1 Week
Best-Corrected Visual Acuity (BCVA) Status at 1 Week
1 Week
The Number of Ophthalmic Adverse Events at 1 Week
1 Week
Study Arms (3)
Artificial Tear Formulation 1
EXPERIMENTALFormulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
Artificial Tear Formulation 2
EXPERIMENTALFormulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
Glycerin and Polysorbate 80 based artificial tear
ACTIVE COMPARATORGlycerin and Polysorbate 80 based artificial tear
Interventions
1 to 2 drops into each eye three times per day
1 to 2 drops into each eye three times per day
1 to 2 drops into each eye three times per day
Eligibility Criteria
You may qualify if:
- Mild, moderate or severe symptoms of dry eye
You may not qualify if:
- Uncontrolled systemic disease
- Contact lens wear
- Participation in another clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
San Diego, California, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2009
First Posted
July 3, 2009
Study Start
August 1, 2009
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
August 26, 2015
Results First Posted
December 13, 2011
Record last verified: 2015-08