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OpenTrials
Completed

NCT Number: NCT00932477

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.

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Diego, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mild, moderate or severe symptoms of dry eye

Exclusion criteria

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

Treatment and study plan

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

Drug

1 to 2 drops into each eye three times per day

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

Drug

1 to 2 drops into each eye three times per day

Glycerin and Polysorbate 80 based artificial tear

Drug

1 to 2 drops into each eye three times per day

Other names: Refresh Dry Eye Therapy®

Primary outcomes

  1. 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

  1. Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week

    Time frame: 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.

  2. Best-Corrected Visual Acuity (BCVA) Status at 1 Week

    Time frame: 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.

  3. The Number of Ophthalmic Adverse Events at 1 Week

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 3, 2009
Registry last updated
Aug 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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