Safety and Tolerability of Artificial Tears in Dry Eye Subjects

Allergan47 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Dry Eye Syndrome

Interventions

Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tearDRUG

1 to 2 drops into each eye three times per day

Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tearDRUG

1 to 2 drops into each eye three times per day

Glycerin and Polysorbate 80 based artificial tearDRUG

1 to 2 drops into each eye three times per day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Mild, moderate or severe symptoms of dry eye Exclusion Criteria: * Uncontrolled systemic disease * Contact lens wear * Participation in another clinical study

Locations (1)

Unnamed facility

San Diego, California, United States

Outcomes

Primary Outcomes

Tolerability Questionnaire Mean Scores at 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.

Time frame: 1 Week

Secondary Outcomes

Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 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.

Time frame: 1 Week

Best-Corrected Visual Acuity (BCVA) Status at 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.

Time frame: 1 Week

The Number of Ophthalmic Adverse Events at 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

Time frame: 1 Week

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.