Safety and Tolerability of Artificial Tears in Dry Eye Subjects
Overview
- Phase
- Not Applicable
- Intervention
- Glycerin and Polysorbate 80 based artificial tear
- Conditions
- Dry Eye Syndrome
- Sponsor
- Allergan
- Enrollment
- 47
- Primary Endpoint
- Tolerability Questionnaire Mean Scores at 1 Week
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Mild, moderate or severe symptoms of dry eye
Exclusion Criteria
- •Uncontrolled systemic disease
- •Contact lens wear
- •Participation in another clinical study
Arms & Interventions
Glycerin and Polysorbate 80 based artificial tear
Glycerin and Polysorbate 80 based artificial tear
Intervention: Glycerin and Polysorbate 80 based artificial tear
Outcomes
Primary Outcomes
Tolerability Questionnaire Mean Scores at 1 Week
Time Frame: 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.
Secondary Outcomes
- 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)