Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline

Dry Eye Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01252121
• Other study ID #: RDG-10-275
• Secondary ID: CS-10-01
• Status: Completed
• Phase: N/A
• First received: November 30, 2010
• Last updated: October 26, 2012
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: May 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 evaluate the ocular retention time of Systane Ultra compared to Hialid and saline.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with mild to moderate dry eye as defined in the protocol.

• Able and willing to follow instructions.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any medical condition that may affect the results of the study.

• History or evidence of ocular or intraocular surgery within the past six months.

• History of intolerance or hypersensitivity to any component of the study medications.

• Use of concomitant topical ocular medications during the study period.

• Ocular conditions that may preclude safe administration of the test article.

• Unwilling to discontinue contact lens wear during the study period.

• Participation in an investigational drug or device study within 30 days of enrollment.

• Other protocol-defined exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Other:
• Systane Ultra Lubricant Eye Drops
One drop in study eye, one time, during office visit.
• Hialid 0.1 Artificial Tears Eye Drops
One drop in study eye, one time, during office visit.
• Unisol 4 Saline Solution
One drop in study eye, one time, during office visit.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular surface residence time	Ocular surface residence time is defined as the time for fluorescence intensity to return to baseline value after a drop of ophthalmic dye is instilled in the study eye. Dye retention will be measured with a fluorophotometer.	Time to event	No