Acute Comfort and Blurring Profile Evaluation of Marketed Lubricant Eye Drops

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00756093
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 4

Study Details

Study Description

Brief Summary

To evaluate drop comfort, acceptability and blur profile between four marketed artificial tears in dry eye patients

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Other: Systane Ultra Lubricant Eye Drops; Other: Optive Lubricant Eye Drops; Other: Blink Tears; Other: GenTeal Moderate 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: Sep 1, 2008
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Systane Ultra Lubricant Eye Drops Systane Ultra Lubricant Eye Drops 1 drop each one time	Other: Systane Ultra Lubricant Eye Drops; Systane Ultra Lubricant Eye Drops one drop each eye one time
Active Comparator: Optive Lubricant Eye Drops Optive Lubricant Eye Drops 1 drop each eye one time	Other: Optive Lubricant Eye Drops; Optive Lubricant Eye Drops one drop each eye one time
Active Comparator: Blink Tears Blink Tears 1 drop each eye one time	Other: Blink Tears; Blink Tears one drop each eye one time
Active Comparator: GenTeal Moderate Lubricant Eye Drops GenTeal Moderate Lubricant Eye Drops 1 drop each eye one time	Other: GenTeal Moderate Lubricant Eye Drops; GenTeal Moderate Lubricant Eye Drops one 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 topical ocular drops within 2 hours preceding enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Call Center	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: NCT00756093
• Other Study ID Numbers: M-08-10
• First Posted: Sep 19, 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, Then Optive, Then Blink Tears, Then GenTeal Moderate	Optive, Then Blink Tears, Then GenTeal Moderate, Then Systane	Blink Tears, Then GenTeal Moderate, Then Systane, Then Optive	GenTeal Moderate, Then Systane, Then Optive, Then Blink Tears
Arm/Group Description	Pateints received Systane first, then Optive, then Blink Tears, then GenTeal Moderate last.	Patients received Optive first, then Blink Tears, then GenTeal Moderate, then Systane	Patients received Blink Tears first, then GenTeal Moderate, then Systane, then Optive last	Patients received GenTeal Moderate first, then Systane, then Optive, then Blink Tears last
Period Title: First Intervention
STARTED	5	5	5	5
COMPLETED	5	5	5	5
NOT COMPLETED	0	0	0	0
Period Title: First Intervention
STARTED	5	5	5	5
COMPLETED	5	5	5	5
NOT COMPLETED	0	0	0	0
Period Title: First Intervention
STARTED	5	5	5	5
COMPLETED	5	5	5	5
NOT COMPLETED	0	0	0	0
Period Title: First Intervention
STARTED	5	5	5	5
COMPLETED	5	5	5	5
NOT COMPLETED	0	0	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	17 85%
Male	3 15%

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 Lubricant Eye Drops	Optive Lubricant Eye Drops	Blink Tears	GenTeal Moderate Lubricant Eye Drops
Arm/Group Description	Systane Ultra Lubricant Eye Drops	Optive Lubricant Eye Drops	Blink Tears	GenTeal Moderate Lubricant Eye Drops
Measure Participants	20	20	20	20
Mean (Standard Deviation) [units on a scale]	0.7 (1.26)	1.05 (1.10)	1.84 (2.19)	1.1 (1.21)

Adverse Events

Arm/Group Title	Systane Ultra Lubricant Eye Drops		Optive Lubricant Eye Drops		Blink Tears		GenTeal Moderate Lubricant Eye Drops
Arm/Group Description	Systane Ultra Lubricant Eye Drops		Optive Lubricant Eye Drops		Blink Tears		GenTeal Moderate Lubricant Eye Drops
All Cause Mortality
	Systane Ultra Lubricant Eye Drops		Optive Lubricant Eye Drops		Blink Tears		GenTeal Moderate Lubricant Eye Drops
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Systane Ultra Lubricant Eye Drops		Optive Lubricant Eye Drops		Blink Tears		GenTeal Moderate Lubricant Eye Drops
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Systane Ultra Lubricant Eye Drops		Optive Lubricant Eye Drops		Blink Tears		GenTeal Moderate Lubricant Eye Drops
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)		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.