CClinicalTrials.gg
CompletedNCT01223040Updated Apr 10, 2012

An Open-Label, Single-Center Study Evaluating the Effect of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in Patients Diagnosed With Dry Eye

An interventional study of SYSTANE® Balance Lubricant Eye Drops in Dry Eye Syndrome, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-04-10.

Sponsored by Alcon Research · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the effect of acute and repeat dosing of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in a population of dry eye patients.

02

Conditions studied

03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients must have history of mild-moderate dry eye with use of (or desire to use) eye drops in past 6 months

Exclusion criteria

Exclusion Criteria:

  • Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Balance.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    SYSTANE® Balance Lubricant Eye Drops

    SYSTANE Balance Lubricant Eye Drops dosed (bilaterally) in the office during each visit. Between visits 2 and 3, patients will dose 4 times per day for the 7 day period.

    Other: SYSTANE® Balance Lubricant Eye Drops

Interventions

  • OtherSYSTANE® Balance Lubricant Eye Drops

    Subjects will be dosed (bilaterally) in the office during each visit. Between visits 2 and 3, patients will dose 4 times per day for the 7 day period.

06

What researchers measure

Primary outcomes

  1. Changes in video Ocular Protection Index 10 and 55 minutes following Systane Balance instillation at Days 1 and 7.

    Time frame: 8 days

Secondary outcomes

  1. Changes in blink pattern in subjects with mean Interblink Interval (IBI) < 3 seconds at Days 2 and 8

    Time frame: 9 days

  2. Fluorescein staining at Visits 1 & 3 on the Ora staining scale

    Time frame: 9 days

  3. Ocular Symptomology at each visit

    Time frame: 9 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01223040
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Oct 18, 2010
Start date
Aug 2010
Primary completion
Sep 2010
Last update
Apr 10, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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