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CompletedNCT04830956Updated Nov 16, 2021

Evaluation of Comfort in Subjects With Moderate Dry Eye Disease

An interventional study of FID123238 and Systane Hydration in Dry Eye, sponsored by Alcon Research. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-16.

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

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the comfort of an ocular lubricant in dry eye subjects. This study will be conducted in Canada and Australia.

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 40 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

Eligibility criteria

Key Inclusion Criteria:

  • Able to understand and sign an information consent letter
  • Willing and able to follow instructions and maintain the appointment schedule
  • Has dry eye symptoms

Key Exclusion Criteria:

  • Has suffered any ocular injury to either eye in the past 12 weeks
  • Is pregnant or lactating at the time of enrollment

Other protocol-specified inclusion/exclusion criteria may apply.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Sequence 1

    FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.

    Other: FID123238 · Other: Systane Hydration

  • Experimental
    Sequence 2

    FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.

    Other: FID123238 · Other: Systane Hydration

  • Experimental
    Sequence 3

    FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.

    Other: FID123238 · Other: Systane Hydration

  • Experimental
    Sequence 4

    FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.

    Other: FID123238 · Other: Systane Hydration

  • Experimental
    Sequence 5

    FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.

    Other: FID123238 · Other: Systane Hydration

Interventions

  • OtherFID123238

    Lubricant applied to the ocular surface

  • OtherSystane Hydration

    Drops applied to the ocular surface

06

What researchers measure

Primary outcomes

  1. Change from baseline in comfort rating

    A visual analogue scale will be used

    Time frame: Baseline, up to 12 Hours (Day 1, each product)

07

Study locations

1 site
  • Alcon Investigator 8169
    Carlton, Victoria 3053, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04830956
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Apr 5, 2021
Start date
Jun 30, 2021
Primary completion
Nov 10, 2021
Completion
Nov 10, 2021
Last update
Nov 16, 2021

Study contacts

Clinical Trial Lead, Dry Eye
study director · Alcon Research, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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