Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye
1 other identifier
interventional
316
1 country
1
Brief Summary
The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2007
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
August 8, 2007
CompletedFirst Posted
Study publicly available on registry
August 10, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedResults Posted
Study results publicly available
December 15, 2009
CompletedDecember 15, 2009
November 1, 2009
3 months
August 8, 2007
May 19, 2009
November 10, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score
Ocular Surface Disease Index© Questionnaire Score is measured on 12 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity)
Change from baseline at Day 30
Secondary Outcomes (7)
Change From Baseline at Day 30 in Schirmer Test, With Anesthesia
Change from baseline at Day 30
Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein
Change from baseline at Day 30
Patient Acceptability Score (Dryness) at Day 30
Day 30
Patient Acceptability Score (Vision) at Day 30
Day 30
Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein
Change from baseline at Day 30
- +2 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALCarboxymethylcellulose and Glycerin based artificial tear
2
ACTIVE COMPARATORCarboxymethylcellulose
Interventions
1 to 2 drops into each eye as needed but at least twice daily
1 to 2 drops into each eye as needed but at least twice daily
Eligibility Criteria
You may qualify if:
- Mild, moderate or Severe Symptoms of Dry Eye
You may not qualify if:
- Uncontrolled systemic disease
- Use of systemic medications affecting dry eye
- Pregnancy or planning a pregnancy
- Contact lens wear
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
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 8, 2007
First Posted
August 10, 2007
Study Start
October 1, 2007
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
December 15, 2009
Results First Posted
December 15, 2009
Record last verified: 2009-11