Acute Comfort and Blur of Systane Ultra and Systane

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00748865
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 1
• Patients Per Site Per Month: 19.6

Study Details

Study Description

Brief Summary

To evaluate drop comfort, acceptability, preference and blue profile between two marketed artificial tears in both dry eyes and non-dry eye patient population.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Other: Systane Ultra Lubricant Eye Drops; Other: Systane Lubricant Eye Drops	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Systane Ultra Systane Ultra 1 drop each eye one time	Other: Systane Ultra Lubricant Eye Drops; Systane Ultra Lubricant Eye Drops 1 drop each eye one time
Active Comparator: Systane Systane 1 drop each eye one time	Other: Systane Lubricant Eye Drops; Systane Lubricant Eye Drops 1 drop each eye one time

Outcome Measures

Primary Outcome Measures

1. Drop Comfort [once upon instillation]

   Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable,

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Documented diagnosis of dry eye

Exclusion Criteria:

• Use of contact lens within 7 days preceding enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Contact Alcon Call Center for Trial Location	Fort Worth	Texas	United States	76134

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: NCT00748865
• Other Study ID Numbers: M-08-09
• First Posted: Sep 9, 2008
• Last Update Posted: Feb 2, 2012
• Last Verified: Jan 1, 2012

• Keywords provided by Alcon Research: Dry Eye; Artificial Tears
• Additional relevant MeSH terms: Dry Eye Syndromes; Ophthalmic Solutions; Lubricant Eye Drops

Study Results

Participant Flow

Recruitment Details	20 dry eye subjects
Pre-assignment Detail	Randomized, double-masked, cross-over design

Arm/Group Title	Systane Ultra Drops, Then Systane Drops	Systane Drops, Then Systane Ultra Drops
Arm/Group Description	Patients received Systane Ultra Drops first, then received Systane Drops.	Patients first received Systane Drops, then received Systane Ultra Drops
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	18 90%
>=65 years	2 10%
Sex: Female, Male (Count of Participants)
Female	19 95%
Male	1 5%

Outcome Measures

1. Primary Outcome

Title	Drop Comfort
Description	Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable,
Time Frame	once upon instillation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Systane Ultra	Systane
Arm/Group Description	Systane Ultra	Systane
Measure Participants	20	20
Median (Standard Deviation) [Units on a scale]	0.55 (0.69)	0.60 (0.68)

Adverse Events

Arm/Group Title	Systane Ultra		Systane
Arm/Group Description	Systane Ultra		Systane
All Cause Mortality
	Systane Ultra		Systane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Systane Ultra		Systane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Systane Ultra		Systane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The PI should hold confidential, and not disclose directly or indirectly to any third party other than Contractors, the data arising out of the study. Alcon reserves the right of prior review of any publication or presentation of information related to the study.