Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects
1 other identifier
interventional
288
1 country
1
Brief Summary
This study will evaluate the safety, efficacy, and acceptability of two artificial tears compared to a currently available artificial tear in subjects with dry eye.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 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
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 6, 2009
CompletedFirst Posted
Study publicly available on registry
November 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
December 13, 2011
CompletedAugust 17, 2015
July 1, 2015
5 months
November 6, 2009
November 9, 2011
July 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90
Change from baseline in SESoD score at day 90. The SESoD is a 5-point scale where 0 equals no dryness, 1 equals trace dryness, 2 equals mild dryness, 3 equals moderate dryness, and 4 equals severe dryness. A negative number change from baseline indicates a decrease (improvement) in the symptom of dryness.
Baseline (Day 1), Day 90
Secondary Outcomes (4)
Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90
Baseline (Day 1), Day 90
Change From Baseline in Tear Break-up Time (TBUT) at Day 90
Baseline (Day 1), Day 90
Change From Baseline in Corneal Staining at Day 90
Baseline (Day 1), Day 90
Change From Baseline in Conjunctival Staining Severity Score at Day 90
Baseline (Day 1), Day 90
Study Arms (3)
Glycerin and Polysorbate 80 based artificial tear
ACTIVE COMPARATORGlycerin and Polysorbate 80 based artificial tear
Artificial Tears Formulation 1
EXPERIMENTALFormulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear
Artificial Tears Formulation 2
EXPERIMENTALFormulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear
Interventions
1-2 drops in each eye, as needed, but at least twice daily
1-2 drops in each eye, as needed, but at least twice daily
1-2 drops in each eye, as needed, but at least twice daily
Eligibility Criteria
You may qualify if:
- Current use of an artificial tear at least twice daily, for at least three months prior to Day 1, on average
- Ability/agreement to wear habitual correction (glasses) during study period
You may not qualify if:
- Known allergy or sensitivity to the study product(s) or its components
- Anticipate contact lens wear during the study, or subject has worn contact lenses in the last six months
- Chronic use of systemic medications which may affect a dry eye condition
- Active ocular allergy or infection
- Use of Restasis® or other topical cyclosporine products within 3 months prior to Day 1
- Current use of any topical ophthalmic medications, have used within 2 weeks prior to Day 1, or are likely to use during study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
San Diego, California, United States
Related Publications (1)
Simmons PA, Carlisle-Wilcox C, Chen R, Liu H, Vehige JG. Efficacy, safety, and acceptability of a lipid-based artificial tear formulation: a randomized, controlled, multicenter clinical trial. Clin Ther. 2015 Apr 1;37(4):858-68. doi: 10.1016/j.clinthera.2015.01.001. Epub 2015 Feb 4.
PMID: 25659956DERIVED
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
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2009
First Posted
November 10, 2009
Study Start
November 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
August 17, 2015
Results First Posted
December 13, 2011
Record last verified: 2015-07