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CompletedNCT01294956Updated Nov 18, 2016

A Clinical Evaluation of an Investigational Lubricant Eye Gel (FID 115958D)

An interventional study of Lubricant Eye Drop and Refresh Liquigel in Dry Eye, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-18.

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

Phase
Not applicable
Study type
Interventional
Enrollment
147
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to estimate the change in sodium fluorescein staining, as a sign of dry eye, during six weeks of treatment with FID 115958D or Refresh Liquigel.

02

Conditions studied

  • Dry Eye

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Keywords

  • Dry eye
  • artificial tears
  • corneal staining
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 147 is above 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.

Browse Alcon Research studies →All Alcon studies →

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

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

  • Documented diagnosis of dry eye
  • NaFl Corneal staining sum score ≥ 3 in either eye
  • Current use of a lubricant eye gel or ointment at least once per week (over the previous month)

Exclusion criteria

Exclusion Criteria:

  • No contact lenses wear throughout the study period
  • Must not have had punctal plugs inserted within 30 days preceding enrollment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
147 participants (actual)

Study arms

  • Experimental
    FID 115958D

    Lubricant Eye Drop

    Other: Lubricant Eye Drop

  • Active comparator
    Refresh Liquigel

    Lubricant Eye Drop

    Other: Refresh Liquigel

Interventions

  • OtherLubricant Eye Drop

    1 drop in each eye, four times a day for 42 days

  • OtherRefresh Liquigel

    1 drop in each eye, four times a day for 42 days

06

What researchers measure

Primary outcomes

  1. Corneal Staining

    Time frame: Day 42

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Cohen S, Martin A, Sall K. Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose. Clin Ophthalmol. 2014;8:157-64. doi: 10.2147/OPTH.S53822. Epub 2013 Dec 31. PubMed 24403819 ↗
09

Timeline

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

The record gives a start of Jan 2011, a primary completion of Apr 2011 and a completion of Apr 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
Feb 10, 2011
First posted
Feb 14, 2011
Start
Jan 2011
Primary completionActual
Apr 2011
CompletionActual
Apr 2011
Last update
Nov 18, 2016
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 Nov 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01294956
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Feb 14, 2011
Start date
Jan 2011
Primary completion
Apr 2011
Completion
Apr 2011
Last update
Nov 18, 2016

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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Discussion

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