Acute Comfort and Blur of Systane and Optive

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00568386
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Duration (Days): 30

Study Details

Study Description

Brief Summary

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

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Acute Comfort and Blurring Profile Evaluation Comparing Systane Lubricant Eye Drops to Optive Lubricant Eye Drops
• Study Start Date: Nov 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Visual Blur [3 minutes post dose]

   Visual blur profile is a visual scale ranging from 0 (no blur) to 50 (most blurry). Patients were asked to rate there vision on a specific focal point (an object in the room) through 3 minutes.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy, normal eyes OR documented diagnosis of dry eye

Exclusion Criteria:

• Must not have worn contact lenses for 7 days preceding enrollment

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Principal Investigator: Mike Christensen, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00568386
• Other Study ID Numbers: M-07-02
• First Posted: Dec 6, 2007
• Last Update Posted: Feb 2, 2012
• Last Verified: Jan 1, 2012

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

Study Results

Participant Flow

Recruitment Details	Medical Clinic Nov. 2007
Pre-assignment Detail	24 hr. wash out between treatment periods

Arm/Group Title	Systane Drops Then Optive Drops	Optive Drops Then Systane Drops
Arm/Group Description	Systane Drops then Optive Drops	Optive Drops then Systane Drops
Period Title: Overall Study
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Systane Drops Then Optive Drops	Optive Drops Then Systane Drops	Total
Arm/Group Description	Systane Drops then Optive Drops	Optive Drops then Systane Drops	Total of all reporting groups
Overall Participants	20	20	40
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	20 100%	20 100%	40 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	17 85%	17 85%	34 85%
Male	3 15%	3 15%	6 15%
Region of Enrollment (participants) [Number]
United States	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Visual Blur
Description	Visual blur profile is a visual scale ranging from 0 (no blur) to 50 (most blurry). Patients were asked to rate there vision on a specific focal point (an object in the room) through 3 minutes.
Time Frame	3 minutes post dose

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Systane Lubricant Eye Drops	Optive Lubricant Eye Drops
Arm/Group Description	Systane lubricant eye drops	Optive Lubricant eye drops
Measure Participants	40	40
Mean (Full Range) [Units on a scale]	27.7	33.55

Adverse Events

Arm/Group Title	Systane Lubricant Eye Drops		Optive Lubricant Eye Drops
Arm/Group Description	Systane lubricant eye drops		Optive Lubricant eye drops
All Cause Mortality
	Systane Lubricant Eye Drops		Optive Lubricant Eye Drops
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Systane Lubricant Eye Drops		Optive Lubricant Eye Drops
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Systane Lubricant Eye Drops		Optive Lubricant Eye Drops
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.