Safety and Tolerability of Artificial Tears in Dry Eye Subjects

Not Applicable

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: Glycerin and Polysorbate 80 based artificial tear

• Registration Number: NCT00932477
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-01
• Study First Submitted QC: 2009-07-02
• Study First Posted: 2009-07-03
• Study Start: 2009-08
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2011-11-09
• Results First Submitted QC: 2011-11-09
• Results First Posted: 2011-12-13
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Mild, moderate or severe symptoms of dry eye

Exclusion Criteria

• Uncontrolled systemic disease
• Contact lens wear
• Participation in another clinical study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glycerin and Polysorbate 80 based artificial tear	Glycerin and Polysorbate 80 based artificial tear	Glycerin and Polysorbate 80 based artificial tear

Primary Outcome Measures

Name	Time	Method
Tolerability Questionnaire Mean Scores at 1 Week	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 Outcome Measures

Name	Time	Method
Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week	1 Week	Number of patients with at least one severity grade increase in biomicroscopy findings at 1 week. Eyes are examined with a special microscope (biomicroscopy), and findings scored using a 5-point scale (0=none, +0.5=trace, +1=mild, +2=moderate, +3=severe). An increase in severity grade indicates worsening.
Best-Corrected Visual Acuity (BCVA) Status at 1 Week	1 Week	BCVA status at 1 week reported as the number of patients whose scores were either "Better", "No Change", or "Worse" than their scores at baseline. The status was tabulated as number of lines read correctly at 1 week minus the number of lines read correctly at baseline. "Better" equals increase of 2 lines or more in at least 1 eye; "No Change" equals change between -2 to +2 lines in either eye; "Worse" equals decrease of 2 lines or more in at least 1 eye. BCVA is measured using a special eye chart and is reported as the number of lines (5 letters per line) read correctly.
The Number of Ophthalmic Adverse Events at 1 Week	1 Week	The number of ophthalmic adverse events (AE) at 1 week. An ophthalmic AE is any unfavorable and unintended sign, symptom, or disease related to the eye which occurs during the use of the study investigational product