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

Not Applicable

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Other: Systane Ultra Lubricant Eye Drops; Other: Hialid 0.1 Artificial Tears Eye Drops; Other: Unisol 4 Saline Solution

• Registration Number: NCT01252121
• Lead Sponsor: Alcon Research

Brief Summary

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-30
• Study First Submitted QC: 2010-12-01
• Study First Posted: 2010-12-02
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-05
• Last Update Submitted: 2012-10-26
• Last Update Posted: 2012-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Systane, Hialid, Unisol	Systane Ultra Lubricant Eye Drops	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.
Systane, Hialid, Unisol	Hialid 0.1 Artificial Tears Eye Drops	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.
Systane, Hialid, Unisol	Unisol 4 Saline Solution	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.
Systane, Unisol, Hialid	Systane Ultra Lubricant Eye Drops	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.
Systane, Unisol, Hialid	Hialid 0.1 Artificial Tears Eye Drops	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.
Systane, Unisol, Hialid	Unisol 4 Saline Solution	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.
Hialid, Systane, Unisol	Systane Ultra Lubricant Eye Drops	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.
Hialid, Systane, Unisol	Hialid 0.1 Artificial Tears Eye Drops	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.
Hialid, Systane, Unisol	Unisol 4 Saline Solution	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.
Hialid, Unisol, Systane	Systane Ultra Lubricant Eye Drops	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.
Hialid, Unisol, Systane	Hialid 0.1 Artificial Tears Eye Drops	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.
Hialid, Unisol, Systane	Unisol 4 Saline Solution	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.
Unisol, Systane, Hialid	Systane Ultra Lubricant Eye Drops	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.
Unisol, Systane, Hialid	Hialid 0.1 Artificial Tears Eye Drops	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.
Unisol, Systane, Hialid	Unisol 4 Saline Solution	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.
Unisol, Hialid, Systane	Systane Ultra Lubricant Eye Drops	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.
Unisol, Hialid, Systane	Hialid 0.1 Artificial Tears Eye Drops	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.
Unisol, Hialid, Systane	Unisol 4 Saline Solution	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.

Primary Outcome Measures

Name	Time	Method
Ocular surface residence time	Time to event	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.