CClinicalTrials.gg
CompletedNCT01252121Updated Oct 30, 2012

Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline

An interventional study of Systane Ultra Lubricant Eye Drops and Hialid 0.1 Artificial Tears Eye Drops in Dry Eye Syndrome, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-30.

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

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the ocular retention time of Systane Ultra compared to Hialid and saline.

02

Conditions studied

  • Dry Eye Syndrome

Browse trials for

Keywords

  • Dry Eye
  • Ocular Retention Time
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 27 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

  • Diagnosed with mild to moderate dry eye as defined in the protocol.
  • Able and willing to follow instructions.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Exclusion Criteria:

  • Any medical condition that may affect the results of the study.
  • History or evidence of ocular or intraocular surgery within the past six months.
  • History of intolerance or hypersensitivity to any component of the study medications.
  • Use of concomitant topical ocular medications during the study period.
  • Ocular conditions that may preclude safe administration of the test article.
  • Unwilling to discontinue contact lens wear during the study period.
  • Participation in an investigational drug or device study within 30 days of enrollment.
  • Other protocol-defined exclusion criteria may apply.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
27 participants (actual)

Study arms

  • Other
    Systane, Hialid, Unisol

    1 drop Systane in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit.

    Other: Systane Ultra Lubricant Eye Drops · Other: Hialid 0.1 Artificial Tears Eye Drops · Other: Unisol 4 Saline Solution

  • Other
    Systane, Unisol, Hialid

    1 drop Systane in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit.

    Other: Systane Ultra Lubricant Eye Drops · Other: Hialid 0.1 Artificial Tears Eye Drops · Other: Unisol 4 Saline Solution

  • Other
    Hialid, Systane, Unisol

    1 drop Hialid in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit.

    Other: Systane Ultra Lubricant Eye Drops · Other: Hialid 0.1 Artificial Tears Eye Drops · Other: Unisol 4 Saline Solution

  • Other
    Hialid, Unisol, Systane

    1 drop Hialid in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit.

    Other: Systane Ultra Lubricant Eye Drops · Other: Hialid 0.1 Artificial Tears Eye Drops · Other: Unisol 4 Saline Solution

  • Other
    Unisol, Systane, Hialid

    1 drop Unisol in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit.

    Other: Systane Ultra Lubricant Eye Drops · Other: Hialid 0.1 Artificial Tears Eye Drops · Other: Unisol 4 Saline Solution

  • Other
    Unisol, Hialid, Systane

    1 drop Unisol in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit.

    Other: Systane Ultra Lubricant Eye Drops · Other: Hialid 0.1 Artificial Tears Eye Drops · Other: Unisol 4 Saline Solution

Interventions

  • OtherSystane Ultra Lubricant Eye Drops

    One drop in study eye, one time, during office visit.

  • OtherHialid 0.1 Artificial Tears Eye Drops

    One drop in study eye, one time, during office visit.

  • OtherUnisol 4 Saline Solution

    One drop in study eye, one time, during office visit.

06

What researchers measure

Primary outcomes

  1. Ocular surface residence time

    Ocular surface residence time is defined as the time for fluorescence intensity to return to baseline value after a drop of ophthalmic dye is instilled in the study eye. Dye retention will be measured with a fluorophotometer.

    Time frame: Time to event

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 Oct 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01252121
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Dec 2, 2010
Start date
Oct 2010
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Oct 30, 2012

Oversight

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

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

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