Skip to main content
OpenTrials
Completed

NCT Number: NCT00514852

Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye

The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear

Completed

Looking for future studies?

Notify Me

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
  • Use of systemic medications affecting dry eye
  • Pregnancy or planning a pregnancy
  • Contact lens wear

Treatment and study plan

Carboxymethylcellulose and Glycerin based artificial tear

Drug

1 to 2 drops into each eye as needed but at least twice daily

Carboxymethylcellulose

Drug

1 to 2 drops into each eye as needed but at least twice daily

Other names: Refresh Plus

Primary outcomes

  1. Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score

    Time frame: Change from baseline at Day 30

    Ocular Surface Disease Index© Questionnaire Score is measured on 12 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity)

Secondary outcomes

  1. Change From Baseline at Day 30 in Schirmer Test, With Anesthesia

    Time frame: Change from baseline at Day 30

    Schirmer Test measures the rate of the secretion of tears

  2. Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein

    Time frame: Change from baseline at Day 30

    Measures the stability of tear film. The average of 3 measures.

  3. Patient Acceptability Score (Dryness) at Day 30

    Time frame: Day 30

    Dryness Severity Visual Analog Scale is measured on a 0-100 point scale (0 = could not be worse, 100 = none at all).

  4. Patient Acceptability Score (Vision) at Day 30

    Time frame: Day 30

    Vision Quality Visual Analog Scale is measured on a 0-100 point scale (0 = very poor, has never been worse, 100 = excellent, has never been better).

  5. Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein

    Time frame: Change from baseline at Day 30

    Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-25 (0= no staining, 25 = most severe staining)

  6. Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein

    Time frame: Change from baseline at Day 30

    Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-30 (0=no staining, 30=most severe staining)

  7. Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score

    Time frame: Change from baseline at Day 30

    Measures dry eye severity on a scale of 0-4 (0 = none, 4 = severe)

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 10, 2007
Registry last updated
Dec 15, 2009

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.