Prevalence of Ocular Surface Disease in Malaysian Glaucoma Patients

October 25, 2020 updated by: Dr. Gan Eng Hui, Santen Pharma Malaysia Sdn Bhd
This is a prospective, multi-centre, cross sectional observational study to determine the prevalence of ocular surface disease (OSD) in glaucoma patients, nationwide. The study also analyses sub group of OSD prevalence, stratified according to the treatment types (i.e. preserved, preservative-free, and combination of preservative-free and preserved eyedrops), and illustrates the patient perspective on OSD.

Study Overview

Status

Unknown

Conditions

Detailed Description

For this prospective, multi-centre, cross sectional observational study, patients who attend routine eye examination at the medical institutions and who have been diagnosed with primary open-angle glaucoma, primary angle-closure glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma or ocular hypertension will be studied. The medical institutions are selected across different regions of Malaysia to assess the nationwide prevalence of OSD in glaucoma patients. The routine assessments include Corneal Evaluation, Tear Break-Up Time (TBUT), Hyperemia and Schirmer's test whereby the data from these assessments will be collected and analyzed. The study will also includes Symptom Evaluation and Questionnaire feedback.

Study Type

Observational

Enrollment (Anticipated)

400

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 Contact Backup

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

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who attend routine eye examination at the medical institutions will be studied. The medical institutions are selected across different regions of Malaysia to assess the nationwide prevalence of OSD in glaucoma patients.

Description

Inclusion Criteria:

  • 1) Age of 21 years or older and those who can provide informed consent.
  • 2) On anti-glaucoma medications for >6 months
  • 3) IOP ≤ 21 mm Hg in the study eye at the screening examination (under treatment)
  • 4) If only one eye is eligible, it is to be evaluated. If both eyes are eligible, then the eye with a higher NEI score will be selected for evaluation.
  • 5) A best-corrected visual acuity score of 6/36 on the Snellen Chart, or better in each eye.

Exclusion Criteria:

  • 1) Those with secondary ocular hypertension or glaucoma
  • 2) Those with severe visual field disorder (mean deviation of 20 dB or worse)
  • 3) Those with a history of ocular surgeries (intraocular surgery including ocular laser treatment which may affect the patient's ocular surface condition) within 6 months prior to the study initiation.
  • 4) Those with a history of glaucoma surgery
  • 5) Those with a history of corneal refractive surgery
  • 6) Those with severe dry eye associated with systemic disorders, or in need of drugs to treat dry eye
  • 7) Those with ocular allergy, ocular infection or ocular inflammation
  • 8) Those using eye drops for other ocular comorbidities
  • 9) Those who need to use systemic or ophthalmic steroids (excluding topical skin steroidal ointment)
  • 10) Female patients who are pregnant, nursing or lactating
  • 11) Those who use contact lenses
  • 12) Any corneal abnormality or other corneal comorbidity condition preventing reliable applanation tonometry
  • 13) Those on oral antihistamine, antipsychotic or anti-depressant drugs.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluorescein staining score (NEI/I)
Time Frame: 1 day
The fluorescein stained area of the cornea and conjunctiva will be measured according to the National Eye Institute/Industry (NEI/I) method.
1 day
Tear Break-Up Time (TBUT)
Time Frame: 1 day
The time (in seconds) until the tear film breaks and the corneal surface is exposed will be measured using a slitlamp microscope.
1 day
Hyperemia score
Time Frame: 1 day
Bulbar and palpebral conjunctiva will be examined using the reference photographs and a 4-step scale. This 4-step scale is cited from the clinical evaluation criteria of Japanese Guideline for Allergic Conjunctival Diseases.
1 day
Schirmer's score
Time Frame: 1 day
The test allows the water in tears to travel along the length of a paper test strip.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom Evaluation
Time Frame: 1 day
Subjects will be evaluated for the presence of symptoms such as irritation/burning/stinging, foreign body sensation, tearing, itching and dry eye sensation.
1 day
Questionnaire feedback
Time Frame: 1 day
Ocular Surface Disease Index (OSDI) patient questionnaire, Glaucoma QOL-15 questionnaire and Patient Experience Questionnaire (PEQ)
1 day

Collaborators and Investigators

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

Sponsor

Santen Pharma Malaysia Sdn Bhd

Investigators

  • Principal Investigator: Eng Hui Gan, Specialist, International Specialist Eye Centre (ISEC)

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

Helpful Links

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)

November 1, 2020

Primary Completion (ANTICIPATED)

April 1, 2021

Study Completion (ANTICIPATED)

May 1, 2021

Study Registration Dates

First Submitted

October 20, 2020

First Submitted That Met QC Criteria

October 25, 2020

First Posted (ACTUAL)

October 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 30, 2020

Last Update Submitted That Met QC Criteria

October 25, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT20-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

To be confirmed

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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