NCT01294956

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

November 18, 2016

Status Verified

January 1, 2012

Enrollment Period

3 months

First QC Date

February 10, 2011

Last Update Submit

November 17, 2016

Conditions

Dry Eye

Keywords

Dry eyeartificial tearscorneal staining

Outcome Measures

Primary Outcomes (1)

  • Corneal Staining

    Day 42

Study Arms (2)

FID 115958D

EXPERIMENTAL

Lubricant Eye Drop

Other: Lubricant Eye Drop

Refresh Liquigel

ACTIVE COMPARATOR

Lubricant Eye Drop

Other: Refresh Liquigel

Interventions

Lubricant Eye DropOTHER

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

FID 115958D
Refresh LiquigelOTHER

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

Refresh Liquigel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 24403819RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Lubricant Eye DropsCarboxymethylcellulose Sodium

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic SolutionsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of ChemicalsMethylcelluloseCelluloseGlucansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 14, 2011

Study Start

January 1, 2011

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

November 18, 2016

Record last verified: 2012-01