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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01252121
• Collaborator: (none)
• Enrollment: 27
• Arms: 6
• Duration (Months): 8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Other: Systane Ultra Lubricant Eye Drops; Other: Hialid 0.1 Artificial Tears Eye Drops; Other: Unisol 4 Saline Solution	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01252121
• Other Study ID Numbers: RDG-10-275; CS-10-01
• First Posted: Dec 2, 2010
• Last Update Posted: Oct 30, 2012
• Last Verified: May 1, 2012

• Keywords provided by Alcon Research: Dry Eye; Ocular Retention Time
• Additional relevant MeSH terms: Dry Eye Syndromes; Ophthalmic Solutions; Lubricant Eye Drops

Study Results

No Results Posted as of Oct 30, 2012