Investigator-initiated Clinical Trial to Observe Conjunctival Goblet Cell Using an Anterior Segment Imaging Device

June 18, 2024 updated by: Chang Ho Yoon, Seoul National University Hospital

Investigator-initiated Exploratory Clinical Trial to Observe Conjunctival Goblet Cell Density Using an Anterior Segment Imaging Device in Patients With Ocular Surface Disease (ODS) and Patients Scheduled for Ocular Surgery Without OSD

Conjunctival goblet cells secrete mucin, vital for tear film stability. Dysfunction can cause tear film issues and lead to diseases like dry eye. Imaging these cells is crucial for diagnosis and treatment. 0.5% moxifloxacin eye drops, an FDA-approved antibiotic, are used to treat bacterial eye infections and prevent infections before surgeries. The investigators developed a non-invasive imaging method for goblet cells, validated in animals, and now plan to test it in humans for diagnosing and treating ocular surface diseases.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Conjunctival goblet cells secrete mucin on the ocular surface, playing a role in forming the mucin layer of the tear film. The mucin layer is crucial for maintaining tear film stability, and dysfunction of conjunctival goblet cells can lead to instability of the mucin layer, causing problems in the tear film. Because various ocular surface diseases stem from tear film instability, imaging of conjunctival goblet cells is essential for diagnosing and treating conditions such as dry eye.

0.5% moxifloxacin eye drops are FDA-approved antibiotics belonging to the quinolone class, widely used to treat bacterial infections in various ocular diseases. Clinically, 0.5% moxifloxacin eye drops are commonly used for purposes such as secondary infection prevention in cases of corneal epithelial defects or perforations caused by ocular surface diseases, as well as for prophylaxis prior to various ophthalmic surgeries, including cataract surgery.

The investigators have previously pioneered non-invasive, high-speed, high-contrast imaging of conjunctival goblet cells. Previous studies have validated the performance and safety of this method by imaging conjunctival goblet cells in mice and rabbit animal models after the instillation of moxifloxacin and illuminating with a 405nm light source using confocal fluorescence microscopy. Furthermore, in this study, the investigators plan to conduct a study involving human subjects to apply our developed conjunctival goblet cell imaging technique for the diagnosis and evaluation of treatment outcomes in ocular surface diseases.

Study Type

Interventional

Enrollment (Estimated)

148

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 Contact

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult patients aged 19 years or older.
  • Patients who are currently using or scheduled to use 0.5% moxifloxacin eye drops for ophthalmic surgery (control group) or for ocular surface diseases (patient group: dry eye, Sjogren's syndrome, Stevens-Johnson syndrome, graft versus host disease).
  • Patients who have agreed to understand and comply with the clinical trial protocol's plans for medical examinations and follow-up observations.

Exclusion Criteria:

  • Pregnant or planning to become pregnant, and lactating women.
  • Patients with intellectual disabilities and other psychiatric disorders who, at the discretion of the investigator, are deemed ineligible for participation in the clinical trial.
  • Patients with hypersensitivity reactions to 0.5% moxifloxacin eye drops, or patients for whom administration is contraindicated.
  • Patients for whom participation in the study is deemed impractical based on the judgment of other medical staff and neutral observers (excluding specified selection/exclusion criteria, based on medical reasons, ethical considerations, low compliance, and understanding of the study).

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with ocular surface disease
Patients diagnosed with dry eye disease, sjogren syndrome, stevens-johnson syndrome, ocular graft versus host disease.
Device: Imaging of conjunctival goblet cell
After instillation of moxifloxacin and illuminating with a 405nm light source using confocal fluorescence microscopy, conjunctival goblet cell imaging will be performed in patients with ocular surface disease and patients scheduled for ocular surgery without ocular surface disease
Other: Patients scheduled for ocular surgery without ocular surface disease
Patients without ocular surface disease and scheduled for cataract surgery which requires moxifloxacin administration
Device: Imaging of conjunctival goblet cell
After instillation of moxifloxacin and illuminating with a 405nm light source using confocal fluorescence microscopy, conjunctival goblet cell imaging will be performed in patients with ocular surface disease and patients scheduled for ocular surgery without ocular surface disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between conjunctival goblet cell density and severity of dry eye
Time Frame: At the time of imaging
Severity of dry eye will be assessed based on tear break up time and corneal punctate erosion score
At the time of imaging

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of conjunctival goblet cell density according to disease and additional parameters related with ocular surface disease
Time Frame: At the time of imaging
Conjunctival punctate erosion score (NEI scale, 0-15), schirmer test (mm), matrix metalloproteinase 9 assay (negative/trace/positive/strong positive), ocular surface disease index (0-100 score) will be assessed as additional parameters.
At the time of imaging

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Chang Ho Yoon, MD PhD, Seoul National University Hospital

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 (Actual)

June 12, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

May 2, 2024

First Submitted That Met QC Criteria

May 19, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 20, 2024

Last Update Submitted That Met QC Criteria

June 18, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2311-108-1485

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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