NCT03079271

Brief Summary

To evaluate the short term effects of LACRISERT®. upon fluorescein corneal staining, tear osmolarity and surface topography in human subjects with dry eye disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 14, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

November 23, 2016

Last Update Submit

March 7, 2017

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (3)

  • Dry Eye disease measured by OSDI questionnaire

    10 days

  • Dry eye disease measured by Corneal Staining

    10 days

  • Dry eye disease measured by topographic results

    10 days

Study Arms (1)

open label

OTHER
Drug: Lacrisert, 5 Mg Ophthalmic Insert

Interventions

Lacrisert, 5 Mg Ophthalmic InsertDRUG
open label

Eligibility Criteria

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

You may qualify if:

  • Has Dry Eye disease indicated by a staining score of ≥ 4 and Speed score of \>6

You may not qualify if:

  • Concurrent involvement in any other clinical trial
  • Anticipated contact lens wear during the study and 14hours prior to Day -History of corneal transplant
  • Active ocular infection, uveitis or non-KCS inflammation
  • History of recurrent herpes keratitis or active disease within the last six months
  • Topical ophthalmic medications during the study
  • Temporary collagen punctal plugs within one week prior to study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

hydroxypropylcellulose

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Central Study Contacts

Jireh A

CONTACT

757-961-2950

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2016

First Posted

March 14, 2017

Study Start

November 1, 2016

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

March 14, 2017

Record last verified: 2017-03

Locations

US(1)