Diadenosine Polyphosphates and Mucin Associated With Ocular Surface Disorders

NCT03731624 | Unknown

• 1 other identifier: TCRD-TPE-107-07
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Dry eye disease, ocular graft-versus-host disease (GVHD), and superior limbic keratoconjunctivitis (SLK) are all ocular surface disorders which mostly involve the outer surface of the eye. Many of the ocular surface disorders may result from or be aggravated by the mechanical stress from eyelid blinking. Specifically, SLK is an inflammatory ocular surface disorder characterizing by redundant superior bulbar conjunctiva. Since redundant superior bulbar conjunctiva can cause a significant mechanical force during eyelid blinking, we found that conjunctival resection with Tenon's capsule excision is helpful in relieving the symptoms of SLK patients. Therapeutic contact lens, protecting the ocular surface from the microtrauma between eyelid and ocular surface, is also an effective treatment for severe dry eye disease, ocular GVHD, and SLK. Although shearing force/mechanical stress has been studied in many different tissues and disease entities, the impact of shearing force over ocular surface is still unclear. While the importance of mechanical stress in ocular surface disorder has been reported, the specific molecule involving the pathogenesis is still unknown. Diadenosine polyphosphates are a family of dinucleotides. They can enhance tear secretion and increase corneal wound healing rate from previous reports. Shear-stress stimuli was also noted to be able to induce diadenosine polyphosphates releasing from human corneal epithelium. In addition, mucin, one of the three components of tear film, has been greatly emphasized in the pathogenesis of dry eye disease. There are also some reports about the shearing force compensating the mucin contents in the inflammatory lung/bowel diseases. If diadenosine polyphosphates or mucin indeed play a role in mechanical stress-related ocular surface disorders, it will be a promising therapeutic targeting in the future.

Conditions

Superior Limbic Keratoconjunctivitis; Dry Eye Syndromes; Graft Vs Host Disease

Outcome Measures

Primary Outcomes (2)

• adenosine polyphosphate level before treatment

  identify the levels of adenosine polyphosphate via High Performance Liquid Chromatography (HPLC) between groups

  before treatment

• mucin level before treatment

  identify the levels of mucin via ELISA between groups

  before treatment

Secondary Outcomes (2)

• adenosine polyphosphate after treatment

  post-treatment one month, three months and six months

• mucin after treatment

  post-treatment one month, three months and six months

Study Arms (4)

SLK

GVHD

Dry eye

Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will have recruit 40 patients with ocular surface disorders (20 dry eye patients, 10 ocular GVHD patients, and 10 SLK patients) and 10 normal subjects. Tear samples and questionnaires before and after treatment (bandage soft contact lens application) will be collected.

You may qualify if:

• age 18 years or older
• diagnosis of dry eye disease, ocular GVHD, and SLK
• patients who ever received topical medications, including artificial tears and topical steroids, at least 3 months, but refractory to the treatment
• absence of new systemic immunosuppressive medications within 1 month

You may not qualify if:

• pregnancy
• absolute neutrophil count less than 1000/mL
• known hypersensitivity or allergy to contact lens care products
• treatment with scleral lenses within the previous 3 months
• evidence of any active infection in the eyes
• receiving any ocular surgeries within the previous 3 months

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Study Sites (1)

Taipei Tzu Chi Hospital

New Taipei City, 231, Taiwan

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes; Graft vs Host Disease

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Immune System Diseases

Study Officials

• Yi-Chen Sun, MD, PhD

  Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Chen Sun, MD, PhD

CONTACT

+886266289779; yichensun.tzuchi@gmail.com

Chiau-Suong Liau, MD

CONTACT

+886266289779; xdirb@tzuchi.com.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: November 6, 2018
• Study Start: January 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2023
• Last Updated: November 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)