Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diadenosine Polyphosphates and Mucin Associated With Ocular Surface Disorders

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03731624
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
yichensun, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

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.


Condition or disease
Superior Limbic Keratoconjunctivitis Dry Eye Syndromes Graft Vs Host Disease

Show Show detailed description

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: The Expression Levels of Diadenosine Polyphosphates and Mucin in Mechanical Stress-related Ocular Surface Disorders
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2023


Group/Cohort
SLK
GVHD
Dry eye
Control



Primary Outcome Measures :
  1. adenosine polyphosphate level before treatment [ Time Frame: before treatment ]
    identify the levels of adenosine polyphosphate via High Performance Liquid Chromatography (HPLC) between groups

  2. mucin level before treatment [ Time Frame: before treatment ]
    identify the levels of mucin via ELISA between groups


Secondary Outcome Measures :
  1. adenosine polyphosphate after treatment [ Time Frame: post-treatment one month, three months and six months ]
    identify the levels of adenosine polyphosphate via HPLC between groups

  2. mucin after treatment [ Time Frame: post-treatment one month, three months and six months ]
    identify the levels of mucin via ELISA between groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT03731624


Contacts
Layout table for location contacts
Contact: Yi-Chen Sun, MD, PhD +886266289779 ext 1220 yichensun.tzuchi@gmail.com
Contact: Chiau-Suong Liau, MD +886266289779 ext 5706 xdirb@tzuchi.com.tw

Locations
Layout table for location information
Taiwan
Taipei Tzu Chi Hospital Recruiting
New Taipei City, Taiwan, 231
Contact: Yi-Chen Sun, MD, PhD    +886266289779 ext 1220    yichensun.tzuchi@gmail.com   
Sponsors and Collaborators
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Investigators
Layout table for investigator information
Principal Investigator: Yi-Chen Sun, MD, PhD Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Additional Information:

Layout table for additonal information
Responsible Party: yichensun, Principal Investigator, Assistant Professor, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
ClinicalTrials.gov Identifier: NCT03731624    
Other Study ID Numbers: TCRD-TPE-107-07
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dry Eye Syndromes
Keratoconjunctivitis
Graft vs Host Disease
Lacrimal Apparatus Diseases
Eye Diseases
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Immune System Diseases