An Evaluation of the Nighttime Retention of Effect of an Investigational Lubricant Eye Drop (FID 115958D)

Dry Eye Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01165164
• Other study ID #: C-10-014
• Status: Completed
• Phase: N/A
• First received: July 16, 2010
• Last updated: January 31, 2012
• Start date: June 2010
• Est. completion date: July 2010

Study information

• Verified date: January 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to describe the night-time use of an investigational lubricant eye drop.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Documented diagnosis of dry eye

2. Current use of an eye ointment or tube gel

Exclusion Criteria:

1. No nighttime contact lenses wear throughout the study period

2. Must not have had punctal plugs inserted within 30 days preceding enrollment

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye

Intervention

Other:
• FID 115958D (lubricant eye drop)
1 drop in each eye at bedtime

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nighttime Use Assessment	Nighttime Use Assessment: "I would use this product at bedtime for my dry eye symptoms" Likert scale (i.e. strongly disagree, disagree, neither disagree nor agree, agree, strongly agree)	Day 7	No