Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline - Full Text View

Purpose

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

Condition	Intervention
Dry Eye Syndrome	Other: Systane Ultra Lubricant Eye Drops Other: Hialid 0.1 Artificial Tears Eye Drops Other: Unisol 4 Saline Solution

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

Resource links provided by NLM:

Genetics Home Reference related topics: keratitis-ichthyosis-deafness syndrome

Drug Information available for: Tetrahydrozoline hydrochloride Boric acid

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Ocular surface residence time [ Time Frame: Time to event ] [ Designated as safety issue: No ]
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.

Enrollment:	27
Study Start Date:	October 2010
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.
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.
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.
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.
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.
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT01252121 History of Changes
Other Study ID Numbers:	RDG-10-275, CS-10-01
Study First Received:	November 30, 2010
Last Updated:	October 26, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Alcon Research:

Dry Eye
Ocular Retention Time

Additional relevant MeSH terms:

Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Tetrahydrozoline

Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013