ClinicalTrials.gg
CompletedNCT01368198Updated Feb 2, 2012

Evaluation of Extended Tear Film Break Up Time (TFBUT) With an Ocular Emulsion

An interventional study of Systane Balance Lubricating Eye Drops and OPTIVE™ in Dry Eye, sponsored by Alcon Research. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-02.

Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary objective of this investigation will be to quantify the increase in tear film break-up time (TFBUT) associated with the instillation of a single eyedrop of an Ocular Emulsion in dry eye sufferers.

Read the detailed description

The secondary objective of this investigation will be to compare the tear film break up time measured with two different techniques.

02

Conditions studied

  • Dry Eye

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Keywords

  • Ocular Emulsion
  • OPTIVE™ Lubricant
  • Tear Film Break Up Time
03

In context

Dry Eye Syndromes

1,325 studies on the registry are indexed under Dry Eye Syndromes; 193 are open to participants now.

This study's enrollment of 50 is below the median of 60 across 1,103 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 100 (90%) 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
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The subject must be 18 years of age or older;
  2. The subject must have a best corrected visual acuity of 0.6 LogMAR (\~6/24) or better in each eye
  3. The subject must not have used any topical ocular drops for approximately 24 hours prior to the enrolment/screening visit
  4. The subject must be classified as dry eye at enrolment/screening visit according to the following criteria:

    • Subjects' self-assessment of dry eye status (answer of at least "some of the time" to the question, "How often have your eyes felt dry enough to want to use eye drops?");
    • TFBUT measured with DET ≤ 5 seconds in at least one eye;
    • Grade 1 for meibomian gland expression in both eyes;
    • Evidence of missing meibomian glands in both eyes.

Exclusion criteria

Exclusion Criteria:

  1. History or evidence of ocular or intraocular surgery in either eye within the past six months.
  2. History or evidence of serious ocular trauma in either eye within the past six months.
  3. Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).
  4. History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
  5. Use of any concomitant topical ocular medications during the study period.
  6. Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation.
  7. Participation in an investigational drug or device study within 30 days of entering this study.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Ocular Emulsion

    An Ocular Emulsion

    Other: Systane Balance Lubricating Eye Drops

  • Active comparator
    OPTIVE™

    An OPTIVE™

    Other: OPTIVE™

Interventions

  • OtherSystane Balance Lubricating Eye Drops

    One instillation of the eye drop in each eye

    Also known as: Ocular Emulsion

  • OtherOPTIVE™

    One instillation of the eye drop in each eye

    Also known as: Optive

06

What researchers measure

Primary outcomes

  1. Measurement of the tear film break-up time using DET sodium fluorescein strips.

    Time frame: Enrollment Test visit 1

Secondary outcomes

  1. Measurement of the tear film break-up time in a non invasive manner using the Tearscope®. Measurement of the tear film break-up time in a non invasive manner using the Tearscope®.

    Time frame: Enrollment Test visit 2

07

Study locations

2 sites
  • Contact Alcon Call Center for Trial Locations
    Fort Worth, Texas 76134, United States
  • OTG Research & Consultancy
    London, England SW1E 6AU, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2011, a primary completion of Jun 2011 and a completion of Jun 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 6, 2011
First posted
Jun 7, 2011
Start
Mar 2011
Primary completionActual
Jun 2011
CompletionActual
Jun 2011
Last update
Feb 2, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01368198
Lead sponsor
Alcon Research
Collaborators
Optometric Technology Group Ltd
Responsible party
Sponsor
First posted
Jun 7, 2011
Start date
Mar 2011
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Feb 2, 2012

Oversight

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

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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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