Acute Comfort and Blur Profile of a Lubricant Eye Drop Versus a Marketed Lubricant Eye Gel

Dry Eye Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01077011
• Other study ID #: C-09-060
• Status: Completed
• Phase: N/A
• First received: February 18, 2010
• Last updated: November 18, 2016
• Start date: January 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 compare the comfort and blurriness of an investigational lubricant eye drop with a marketed lubricant eye gel.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented diagnosis of dry eye

Exclusion Criteria:

• Must not have worn contact lenses within 12 hours preceding enrollment

• Must not have used any topical ocular drops or ointment within 24 hours preceding enrollment

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye

Intervention

Other:
• Lubricant eye drop FID 115958D
1 drop in each eye, one time
• GenTeal Gel
1 drop in each eye, one time

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

References & Publications (1)

http://www.aaopt.org/evaluation-efficacy-and-patient-acceptance-new-lubricant-eye-gel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Three-minute visual blur profile		Through 3 minutes (post-instillation)	No
Primary	Overall Acceptability		Immediately upon instillation	No
Secondary	Drop Comfort Upon Instillation		Immediately upon installation	No