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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01294956

Enrollment

147

Registered

2011-02-14

Start date

2011-01-31

Completion date

2011-04-30

Last updated

2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

Keywords

Dry eye, artificial tears, corneal staining

Brief 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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

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

Design outcomes

Primary

Measure	Time frame
Corneal Staining	Day 42

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026