Trial Outcomes & Findings for Acute Comfort and Blur of Systane and Optive (NCT NCT00568386)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

3 minutes post dose

Results posted on

2012-02-02

Participant Flow

Medical Clinic Nov. 2007

24 hr. wash out between treatment periods

Participant milestones

Participant milestones
Measure	Systane Drops Then Optive Drops Systane Drops then Optive Drops	Optive Drops Then Systane Drops Optive Drops then Systane Drops
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acute Comfort and Blur of Systane and Optive

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Systane Drops Then Optive Drops n=20 Participants Systane Drops then Optive Drops	Optive Drops Then Systane Drops n=20 Participants Optive Drops then Systane Drops	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Systane Lubricant Eye Drops n=40 Participants Systane lubricant eye drops	Optive Lubricant Eye Drops n=40 Participants Optive Lubricant eye drops
Visual Blur	27.7 Units on a scale Interval 0.0 to 49.0	33.55 Units on a scale Interval 10.0 to 50.0

Adverse Events

Systane Lubricant Eye Drops

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Optive Lubricant Eye Drops

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alcon Clinical

Alcon Research

Phone: 888.451.3937; 817.568.6725

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place