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Prevalence of Ocular Surface Disease in Malaysian Glaucoma Patients

Sponsor
Santen Pharma Malaysia Sdn Bhd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04609345
Collaborator
(none)
400
Enrollment
5.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Prevalence of Ocular Surface Disease in Malaysian Glaucoma Patients
    Anticipated Study Start Date :
    Nov 1, 2020
    Anticipated Primary Completion Date :
    Apr 1, 2021
    Anticipated Study Completion Date :
    May 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Fluorescein staining score (NEI/I) [1 day]

      The fluorescein stained area of the cornea and conjunctiva will be measured according to the National Eye Institute/Industry (NEI/I) method.

    2. Tear Break-Up Time (TBUT) [1 day]

      The time (in seconds) until the tear film breaks and the corneal surface is exposed will be measured using a slitlamp microscope.

    3. Hyperemia score [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.

    4. Schirmer's score [1 day]

      The test allows the water in tears to travel along the length of a paper test strip.

    Secondary Outcome Measures

    1. Symptom Evaluation [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.

    2. Questionnaire feedback [1 day]

      Ocular Surface Disease Index (OSDI) patient questionnaire, Glaucoma QOL-15 questionnaire and Patient Experience Questionnaire (PEQ)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. Age of 21 years or older and those who can provide informed consent.
      1. On anti-glaucoma medications for >6 months
      1. IOP ≤ 21 mm Hg in the study eye at the screening examination (under treatment)
      1. 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.
      1. 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
      1. Those with severe visual field disorder (mean deviation of 20 dB or worse)
      1. 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.
      1. Those with a history of glaucoma surgery
      1. Those with a history of corneal refractive surgery
      1. Those with severe dry eye associated with systemic disorders, or in need of drugs to treat dry eye
      1. Those with ocular allergy, ocular infection or ocular inflammation
      1. Those using eye drops for other ocular comorbidities
      1. Those who need to use systemic or ophthalmic steroids (excluding topical skin steroidal ointment)
      1. Female patients who are pregnant, nursing or lactating
      1. Those who use contact lenses
      1. Any corneal abnormality or other corneal comorbidity condition preventing reliable applanation tonometry
      1. Those on oral antihistamine, antipsychotic or anti-depressant drugs.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Santen Pharma Malaysia Sdn Bhd

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Dr. Gan Eng Hui, Principal Investigator, International Specialist Eye Centre
    ClinicalTrials.gov Identifier:
    NCT04609345
    Other Study ID Numbers:
    • CT20-004
    First Posted:
    Oct 30, 2020
    Last Update Posted:
    Oct 30, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Glaucoma
    Glaucoma, Open-Angle
    Ocular Hypertension
    Glaucoma, Angle-Closure
    Exfoliation Syndrome

    Study Results

    No Results Posted as of Oct 30, 2020