NCT02160327

Brief Summary

The specific aims of the the investigators studies are as follows:

  • To collect the tear samples from patients with different ocular surface disorders, including SLK, conjunctivochalasis, and keratoconjunctivitis sicca (KCS).
  • To evaluate the differential expression of tear cytokines and pH values between different ocular surface disorders.
  • To collect the surgical conjunctival specimens from the patients with SLK and conjunctivochalasis.
  • To evaluate the factors inducing mast cell migration and how mast cell is activated in SLK via surgical specimens and cultivated fibroblast.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

3.8 years

First QC Date

May 27, 2014

Last Update Submit

June 23, 2014

Conditions

Superior Limbic KeratoconjunctivitisConjunctivochalasisDry Eye

Outcome Measures

Primary Outcomes (1)

  • Tear cytokines change measured by ELISA

    Tear will be collected before treatment, one month and six months follow-up visits

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Part I. Tear sample diagnosed as a patients of superior limbic keratoconjunctivitis (SLK) or conjunctivochalasis or keratoconjunctivitis sicca (KCS) Part II. Surgical conjunctiva specimen disease group: SLK or conjunctivochalasis patients refractory to medical treatment and receiving conjunctival resection surgery

You may qualify if:

  • age 20-85 years old
  • diagnosed as a patients of superior limbic keratoconjunctivitis (SLK) or conjunctivochalasis or keratoconjunctivitis sicca (KCS)

You may not qualify if:

  • pregnancy
  • any ocular surgery within 3 months
  • Part II. Surgical conjunctiva specimen
  • age 20-85 years old
  • disease group: SLK or conjunctivochalasis patients refractory to medical treatment and receiving conjunctival resection surgery
  • control group: patients receiving retinal or cataract surgery with redundant conjunctiva after peritomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng Dist, 100, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

* tear * conjunctival tissue

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Fung-Rong Hu, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2014

First Posted

June 10, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

June 24, 2014

Record last verified: 2014-06

Locations

TW(1)