At a glance
ClinicalIndex Comparison RecordN/ACompleted· 288 enrolled
Drug / intervention
Glycerin and Polysorbate 80 based artificial tear +2 moredrug
Likely dose
1-2 drops in each eye, as needed, but at least twice dailyAI-extracted
Key inclusion· 2
- ✓Current use of artificial tear at least twice daily for at least 3 months prior to enrollment
- ✓Ability and agreement to wear habitual glasses during study period
Key exclusion· 6
- ✕Known allergy or sensitivity to study product components
- ✕Contact lens wear anticipated during study or worn within 6 months
- ✕Chronic systemic medications that may affect dry eye condition
- ✕Active ocular allergy or infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects
In Brief
A clinical study evaluating Glycerin and Polysorbate 80 based artificial tear, Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear, and 1 other intervention for Dry Eye Syndrome. Completed, enrolled 288 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndrome
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2009
First PostedNov 2009
Primary CompletionApr 2010
TodayJul 2026
First PostedNov 10, 2009
Enrollment StartNov 1, 2009
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.6 years ago
Interventions
Glycerin and Polysorbate 80 based artificial teardrug
1-2 drops in each eye, as needed, but at least twice daily
Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial teardrug
1-2 drops in each eye, as needed, but at least twice daily
Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial teardrug
1-2 drops in each eye, as needed, but at least twice daily