Safety and Tolerability of Artificial Tears in Dry Eye Subjects

Dry Eye Syndrome Clinical Trial

Official title:

Safety and Tolerability of Artificial Tears in Dry Eye Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932477
• Other study ID #: AG9965-001
• Status: Completed
• Phase: N/A
• First received: July 1, 2009
• Last updated: August 17, 2015
• Start date: August 2009
• Est. completion date: September 2009

Study information

• Verified date: August 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
1 to 2 drops into each eye three times per day
• Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
1 to 2 drops into each eye three times per day
• Glycerin and Polysorbate 80 based artificial tear
1 to 2 drops into each eye three times per day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No