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An Open Label Comparing the Short Term Efficacy of Lacrisert

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03079271
Recruitment Status : Unknown
Verified March 2017 by Virginia Eye Consultants.
Recruitment status was:  Recruiting
First Posted : March 14, 2017
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Virginia Eye Consultants

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.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Lacrisert, 5 Mg Ophthalmic Insert Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An Open Label Comparing the Short Term Efficacy of Lacrisert
Study Start Date : November 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
open label Drug: Lacrisert, 5 Mg Ophthalmic Insert



Primary Outcome Measures :
  1. Dry Eye disease measured by OSDI questionnaire [ Time Frame: 10 days ]
  2. Dry eye disease measured by Corneal Staining [ Time Frame: 10 days ]
  3. Dry eye disease measured by topographic results [ Time Frame: 10 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079271


Contacts
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Contact: Jireh A 757-961-2950

Locations
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United States, Virginia
Virginia Eye Consultants Recruiting
Norfolk, Virginia, United States, 23502
Contact: jireh A, COA    757-961-2947      
Principal Investigator: John D Sheppard, M.D.         
Sponsors and Collaborators
Virginia Eye Consultants
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Responsible Party: Virginia Eye Consultants
ClinicalTrials.gov Identifier: NCT03079271    
Other Study ID Numbers: VEC-LAC001
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Benzocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents