Wireless Micropump in Dry Eye Patients

December 12, 2020 updated by: Tianjin Eye Hospital

Clinical Efficacy of Wireless Micropump in Dry Eye Patients

The purpose of this study is to carry out a trial to get more convincing and valuable results of the wireless micropump in dry eye patients and compare the outcomes before and after eye drops usage. The investigators hope to investigate the micropump comprehensively, including the comparison of tear film break-up time, corneal epithelium defect percentage, and tear film thickness. To meet the demands of a trial, all the examination equipment should be the same for each patient, and this will limit the variations within a study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to carry out a trial to get more convincing and valuable results of the wireless micropump in dry eye patients and compare the outcomes before and after eye drops usage. The investigators hope to investigate the micropump comprehensively, including the comparison of tear film break-up time, corneal epithelium defect percentage, and tear film thickness. To meet the demands of a trial, all the examination equipment and methods should be the same for each patient, and this will limit the variations within a study.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elimination of serious mental and psychological diseases;
  • be accompanied by a parent or guardian who is able to give informed consent as demonstrated by signing a record of informed consent;
  • be willing to comply with the clinical trial visit schedule as directed by the investigator;
  • at baseline, be within the age range of 18 to 80 years old inclusive;
  • BCVA≥1.0 of both eyes for each patient;
  • dry eye test is BUT<5s and or Schimer test<5mm/5min；
  • without other ophthalmic diseases;

Exclusion Criteria:

  • At the same time, patients with other eye diseases (such as glaucoma, corneal opacity, uveitis, etc.) were diagnosed;
  • serious mental and psychological diseases;
  • history of refractive surgery;
  • nystagmus or failure to cooperate;
  • history of intraocular surgery;
  • patients with systemic diseases (such as diabetes, hypertension, heart disease, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sodium hyaluronate
Sodium hyaluronate has become a novel and effective eye drop for the treatment of the dry eye. However, we design a special method of usage of sodium hyaluronate in dry eye patients.
Drug: Sodium Hyaluronate
We usage a special type of anterior eye drug delivery system to conduct the transmission of sodium hyaluronate in dry eye patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tear film break-up time
Time Frame: change from baseline with OCCULUS at 6 months
change before and after sodium hyaluronate with OCCULUS
change from baseline with OCCULUS at 6 months
tear film thickness
Time Frame: change from baseline with OCCULUS at 6 months
change before and after sodium hyaluronate with OCCULUS
change from baseline with OCCULUS at 6 months
corneal epithelium defect percentage
Time Frame: change from baseline with OCCULUS at 6 months
change before and after sodium hyaluronate with OCCULUS
change from baseline with OCCULUS at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Eye Hospital

Collaborators

Tianjin University

Investigators

  • Study Director: Yan Wang, director, Tianjin Eye Hospital
  • Principal Investigator: Xuexin Duan, professor, Tianjin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 12, 2020

First Posted (Actual)

December 16, 2020

Study Record Updates

Last Update Posted (Actual)

December 16, 2020

Last Update Submitted That Met QC Criteria

December 12, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202076

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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