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

Primary Purpose

Dry Eye

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Systane Ultra Lubricant Eye Drops
Optive Lubricant Eye Drops
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Documented diagnosis of dry eye
  • Must not have worn contact lenses for 12 hours prior to Day 1

Exclusion Criteria:

  • Age related

Sites / Locations

  • North Andover

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Systane Ultra

Optive

Arm Description

Systane Ultra Lubricant Eye Drops

Optive Lubricant Eye Drops

Outcomes

Primary Outcome Measures

Time at Best Corrected Visual Acuity
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

Functional Blink Rate Time (Time Between Blinks)
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.

Full Information

First Posted
May 2, 2008
Last Updated
January 31, 2012
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00673764
Brief Title
The Effect of Systane Ultra Lubricant Eye Drops (FID 112903) on Visual Performance
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Systane Ultra
Arm Type
Experimental
Arm Description
Systane Ultra Lubricant Eye Drops
Arm Title
Optive
Arm Type
Active Comparator
Arm Description
Optive Lubricant Eye Drops
Intervention Type
Other
Intervention Name(s)
Systane Ultra Lubricant Eye Drops
Intervention Description
Systane Ultra Lubricant Eye Drops 1 drop each eye one time
Intervention Type
Other
Intervention Name(s)
Optive Lubricant Eye Drops
Intervention Description
Optive Lubricant Eye Drops 1 drop each eye one time
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented diagnosis of dry eye Must not have worn contact lenses for 12 hours prior to Day 1 Exclusion Criteria: Age related
Facility Information:
Facility Name
North Andover
City
North Andover
State/Province
Massachusetts
ZIP/Postal Code
01845
Country
United States

12. IPD Sharing Statement

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

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