Recruiting

Lacrisert

Sponsor:

Virginia Eye Consultants

Code:

NCT03079271

Conditions

Dry Eye

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lacrisert, 5 Mg Ophthalmic Insert

Study Details

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.

Conditions

Dry Eye

Study ID

NCT03079271

Start date

Nov, 2016

Status verified date

Mar, 2017

Completion date

Dec, 2017

Anticipated

Primary completion date

Jun, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: open label

Interventions

Lacrisert, 5 Mg Ophthalmic Insert

Primary outcome measure

  • Dry Eye disease measured by OSDI questionnaire [ Time Frame: 10 days ]
  • Dry eye disease measured by Corneal Staining [ Time Frame: 10 days ]
  • Dry eye disease measured by topographic results [ Time Frame: 10 days ]

Central Contacts and Locations

Central contacts

Jireh A

757-961-2950

Locations

Virginia Eye Consultants

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

jireh A, COA

757-961-2947

Principal Investigator:

John D Sheppard, M.D.

More Information

Sponsor

Virginia Eye Consultants

Last update posted

Mar 14, 2017

Last verified

Mar, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Virginia Eye Consultants on 2017-03-14.