The Effect of Systane Ultra Lubricant Eye Drops (FID 112903) on Visual Performance

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00673764
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Duration (Months): 1
• Patients Per Site Per Month: 47.1

Study Details

Study Description

Brief Summary

To evaluate the effect of 2 different lubricant eye drops on visual function of patients with dry eye

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Time at Best Corrected Visual Acuity [15 minutes, 45 minutes, and 90 minutes post-dose]

   Measuring length of time patient can maintain their best vision while completing a computer task. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Corrected visual acuity means the patient can wear glasses or contacts if needed such that the measure is performed with the patient seeing the best that they can.

Secondary Outcome Measures

1. Functional Blink Rate Time (Time Between Blinks) [15 minutes, 45 minutes, and 90 minutes post-dose]

   Measures time in seconds between normal blinks. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Longer blink rate time correlates with improved visual performance.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Documented diagnosis of dry eye

• Must not have worn contact lenses for 12 hours prior to Day 1

Exclusion Criteria:

• Age related

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Andover	North Andover	Massachusetts	United States	01845

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: NCT00673764
• Other Study ID Numbers: C-07-24
• First Posted: May 7, 2008
• Last Update Posted: Feb 2, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Dry Eye Syndromes; Ophthalmic Solutions; Lubricant Eye Drops

Study Results

Participant Flow

Recruitment Details	48 Dry Eye Subjects
Pre-assignment Detail	Randomized, double-masked, crossover

Arm/Group Title	Systane Ultra, Then Optive	Optive, Then Systane Ultra
Arm/Group Description	Systane Ultra Lubricant Eye Drops first, then cross-over to Optive.	Optive Lubricant Eye Drops first, then cross-over to Systane Ultra.
Period Title: Overall Study
STARTED	24	24
COMPLETED	24	24
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Overall Study
Overall Participants	48
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	26 54.2%
>=65 years	22 45.8%
Sex: Female, Male (Count of Participants)
Female	38 79.2%
Male	10 20.8%

Outcome Measures

1. Primary Outcome

Title	Time at Best Corrected Visual Acuity
Description	Measuring length of time patient can maintain their best vision while completing a computer task. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Corrected visual acuity means the patient can wear glasses or contacts if needed such that the measure is performed with the patient seeing the best that they can.
Time Frame	15 minutes, 45 minutes, and 90 minutes post-dose

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Systane Ultra	Optive
Arm/Group Description	Systane Ultra Lubricant Eye Drops.	Optive Lubricant Eye Drops
Measure Participants	48	48
15 minutes post-dose	7.75 (0.6545)	6.42 (.6545)
45 minutes post-dose	6.46 (0.4003)	5.51 (0.4003)
90 minutes post-dose	9.17 (0.0365)	6.84 (0.0365)

2. Secondary Outcome

Title	Functional Blink Rate Time (Time Between Blinks)
Description	Measures time in seconds between normal blinks. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Longer blink rate time correlates with improved visual performance.
Time Frame	15 minutes, 45 minutes, and 90 minutes post-dose

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Systane Ultra	Optive
Arm/Group Description	Systane Ultra Lubricant Eye Drops.	Optive Lubricant Eye Drops
Measure Participants	48	48
15 minutes post-dose	5.9 (5.5)	5.8 (4.7)
45 minutes post-dose	5.9 (5.4)	6.7 (4.9)
90 minutes post-dose	6.5 (5.8)	7.3 (6.0)

Adverse Events

Arm/Group Title	Systane Ultra		Optive
Arm/Group Description	Systane Ultra Lubricant Eye Drops.		Optive Lubricant Eye Drops
All Cause Mortality
	Systane Ultra		Optive
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Systane Ultra		Optive
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/48 (0%)
Other (Not Including Serious) Adverse Events
	Systane Ultra		Optive
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/48 (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.