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

The purpose of this study is to evaluate the ocular retention time of Systane Ultra compared to Hialid and saline.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Other: Systane Ultra Lubricant Eye Drops; Other: Hialid 0.1 Artificial Tears Eye Drops; Other: Unisol 4 Saline Solution

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Systane, Hialid, Unisol; 1 drop Systane in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit.	Other: Systane Ultra Lubricant Eye Drops; One drop in study eye, one time, during office visit.; Other: Hialid 0.1 Artificial Tears Eye Drops; One drop in study eye, one time, during office visit.; Other: Unisol 4 Saline Solution; One drop in study eye, one time, during office visit.
Other: Systane, Unisol, Hialid; 1 drop Systane in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit.	Other: Systane Ultra Lubricant Eye Drops; One drop in study eye, one time, during office visit.; Other: Hialid 0.1 Artificial Tears Eye Drops; One drop in study eye, one time, during office visit.; Other: Unisol 4 Saline Solution; One drop in study eye, one time, during office visit.
Other: Hialid, Systane, Unisol; 1 drop Hialid in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit.	Other: Systane Ultra Lubricant Eye Drops; One drop in study eye, one time, during office visit.; Other: Hialid 0.1 Artificial Tears Eye Drops; One drop in study eye, one time, during office visit.; Other: Unisol 4 Saline Solution; One drop in study eye, one time, during office visit.
Other: Hialid, Unisol, Systane; 1 drop Hialid in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit.	Other: Systane Ultra Lubricant Eye Drops; One drop in study eye, one time, during office visit.; Other: Hialid 0.1 Artificial Tears Eye Drops; One drop in study eye, one time, during office visit.; Other: Unisol 4 Saline Solution; One drop in study eye, one time, during office visit.
Other: Unisol, Systane, Hialid; 1 drop Unisol in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit.	Other: Systane Ultra Lubricant Eye Drops; One drop in study eye, one time, during office visit.; Other: Hialid 0.1 Artificial Tears Eye Drops; One drop in study eye, one time, during office visit.; Other: Unisol 4 Saline Solution; One drop in study eye, one time, during office visit.
Other: Unisol, Hialid, Systane; 1 drop Unisol in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit.	Other: Systane Ultra Lubricant Eye Drops; One drop in study eye, one time, during office visit.; Other: Hialid 0.1 Artificial Tears Eye Drops; One drop in study eye, one time, during office visit.; Other: Unisol 4 Saline Solution; One drop in study eye, one time, during office visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: November 30, 2010
• First Submitted That Met QC Criteria: December 1, 2010
• First Posted (Estimate): December 2, 2010

Study Record Updates

• Last Update Posted (Estimate): October 30, 2012
• Last Update Submitted That Met QC Criteria: October 26, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Dry Eye; Ocular Retention Time
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Pharmaceutical Solutions; Ophthalmic Solutions; Lubricant Eye Drops
• Other Study ID Numbers: RDG-10-275; CS-10-01 (Other Identifier: Xiamen University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No