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

Dry Eye Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00514852
• Other study ID #: AG9818-002
• Status: Completed
• Phase: N/A
• First received: August 8, 2007
• Last updated: November 10, 2009
• Start date: October 2007
• Est. completion date: January 2008

Study information

• Verified date: November 2009
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• 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

• Use of systemic medications affecting dry eye

• Pregnancy or planning a pregnancy

• Contact lens wear

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Carboxymethylcellulose and Glycerin based artificial tear
1 to 2 drops into each eye as needed but at least twice daily
• Carboxymethylcellulose
1 to 2 drops into each eye as needed but at least twice daily

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	Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score		Change from baseline at Day 30	No
Secondary	Change From Baseline at Day 30 in Schirmer Test, With Anesthesia		Change from baseline at Day 30	No
Secondary	Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein		Change from baseline at Day 30	No
Secondary	Patient Acceptability Score (Dryness) at Day 30		Day 30	No
Secondary	Patient Acceptability Score (Vision) at Day 30		Day 30	No
Secondary	Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein		Change from baseline at Day 30	No
Secondary	Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein		Change from baseline at Day 30	No
Secondary	Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score		Change from baseline at Day 30	No