Safety and Tolerability of Artificial Tears in Dry Eye Subjects

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 Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Drug: Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear; Drug: Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear; Drug: Glycerin and Polysorbate 80 based artificial tear

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Mild, moderate or severe symptoms of dry eye

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glycerin and Polysorbate 80 based artificial tear	Drug: Glycerin and Polysorbate 80 based artificial tear; 1 to 2 drops into each eye three times per day; Other Names: Refresh Dry Eye Therapy®
Experimental: Artificial Tear Formulation 1; Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear	Drug: Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear; 1 to 2 drops into each eye three times per day
Experimental: Artificial Tear Formulation 2; Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear	Drug: Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear; 1 to 2 drops into each eye three times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 Week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	1 Week

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: July 1, 2009
• First Submitted That Met QC Criteria: July 2, 2009
• First Posted (Estimate): July 3, 2009

Study Record Updates

• Last Update Posted (Estimate): August 26, 2015
• Last Update Submitted That Met QC Criteria: August 17, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Gastrointestinal Agents; Protective Agents; Pharmaceutical Solutions; Laxatives; Cryoprotective Agents; Ophthalmic Solutions; Glycerol; Lubricant Eye Drops; Carboxymethylcellulose Sodium
• Other Study ID Numbers: AG9965-001