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Primary Open-angle GlaucomaNCT04609345

Prevalence of Ocular Surface Disease in Malaysian Glaucoma Patients

An observational study of Primary Open-angle Glaucoma and Primary Angle-Closure Glaucoma, run by Santen Pharma Malaysia Sdn Bhd.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
How many people
400 participants
Where
No sites listed yet
Study dates
Nov 2020to May 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet.

Dr. Gan contact

603-22848989

ganenghui@yahoo.com.my

Veni contact

603-22763333

veni.venusha.sakti@santen.com

About this study

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.

Read the 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.

Medical subject headings
Glaucoma, Open-Angle, Glaucoma, Angle-Closure, Exfoliation Syndrome, Ocular Hypertension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fluorescein staining score (NEI/I)

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

    Measured: 1 day

  2. Tear Break-Up Time (TBUT)

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

    Measured: 1 day

  3. Hyperemia score

    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.

    Measured: 1 day

  4. Schirmer's score

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

    Measured: 1 day

Secondary outcomes (2)

  1. Symptom Evaluation

    Subjects will be evaluated for the presence of symptoms such as irritation/burning/stinging, foreign body sensation, tearing, itching and dry eye sensation.

    Measured: 1 day

  2. Questionnaire feedback

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

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2020
  2. Study startNov 2020 (estimated)
  3. Primary completionApr 2021 (estimated)
  4. Study completionMay 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04609345
Sponsor's protocol ID
CT20-004
Status last verified
Oct 2020
First submitted
20 Oct 2020
Last updated
30 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: To be confirmed

Publications

  • Harasymowycz P, Birt C, Gooi P, Heckler L, Hutnik C, Jinapriya D, Shuba L, Yan D, Day R. Medical Management of Glaucoma in the 21st Century from a Canadian Perspective. J Ophthalmol. 2016;2016:6509809. doi: 10.1155/2016/6509809. Epub 2016 Nov 8.

    PubMed 27895937

  • Jonas JB, Aung T, Bourne RR, Bron AM, Ritch R, Panda-Jonas S. Glaucoma. Lancet. 2017 Nov 11;390(10108):2183-2193. doi: 10.1016/S0140-6736(17)31469-1. Epub 2017 May 31.

    PubMed 28577860

  • Perez-Bartolome F, Martinez-de-la-Casa JM, Arriola-Villalobos P, Fernandez-Perez C, Polo V, Garcia-Feijoo J. Ocular Surface Disease in Patients under Topical Treatment for Glaucoma. Eur J Ophthalmol. 2017 Nov 8;27(6):694-704. doi: 10.5301/ejo.5000977.

    PubMed 28497458

  • Mathews PM, Ramulu PY, Friedman DS, Utine CA, Akpek EK. Evaluation of ocular surface disease in patients with glaucoma. Ophthalmology. 2013 Nov;120(11):2241-8. doi: 10.1016/j.ophtha.2013.03.045. Epub 2013 May 25.

    PubMed 23714318

  • Saade CE, Lari HB, Berezina TL, Fechtner RD, Khouri AS. Topical glaucoma therapy and ocular surface disease: a prospective, controlled cohort study. Can J Ophthalmol. 2015 Apr;50(2):132-6. doi: 10.1016/j.jcjo.2014.11.006.

    PubMed 25863853

  • Inoue K. Managing adverse effects of glaucoma medications. Clin Ophthalmol. 2014 May 12;8:903-13. doi: 10.2147/OPTH.S44708. eCollection 2014.

    PubMed 24872675

  • Ramli N, Supramaniam G, Samsudin A, Juana A, Zahari M, Choo MM. Ocular Surface Disease in Glaucoma: Effect of Polypharmacy and Preservatives. Optom Vis Sci. 2015 Sep;92(9):e222-6. doi: 10.1097/OPX.0000000000000542.

    PubMed 25730335

  • Garcia-Feijoo J, Sampaolesi JR. A multicenter evaluation of ocular surface disease prevalence in patients with glaucoma. Clin Ophthalmol. 2012;6:441-6. doi: 10.2147/OPTH.S29158. Epub 2012 Mar 22.

    PubMed 22536034

  • Ogawa Y, Kim SK, Dana R, Clayton J, Jain S, Rosenblatt MI, Perez VL, Shikari H, Riemens A, Tsubota K. International Chronic Ocular Graft-vs-Host-Disease (GVHD) Consensus Group: proposed diagnostic criteria for chronic GVHD (Part I). Sci Rep. 2013 Dec 5;3:3419. doi: 10.1038/srep03419.

    PubMed 24305504

  • Sencanic I, Gazibara T, Dotlic J, Stamenkovic M, Jaksic V, Bozic M, Grgurevic A. Validation of the Glaucoma Quality of Life-15 Questionnaire in Serbian language. Int J Ophthalmol. 2018 Oct 18;11(10):1674-1684. doi: 10.18240/ijo.2018.10.16. eCollection 2018.

    PubMed 30364180

  • Takamura E, Uchio E, Ebihara N, Ohno S, Ohashi Y, Okamoto S, Kumagai N, Satake Y, Shoji J, Nakagawa Y, Namba K, Fukagawa K, Fukushima A, Fujishima H; Japanese Society of Allergology. Japanese guideline for allergic conjunctival diseases. Allergol Int. 2011 Mar;60(2):191-203. doi: 10.2332/allergolint.11-RAI-0335.

    PubMed 21636966

  • Masumoto H, Tabuchi H, Yoneda T, Nakakura S, Ohsugi H, Sumi T, Fukushima A. Severity Classification of Conjunctival Hyperaemia by Deep Neural Network Ensembles. J Ophthalmol. 2019 Jun 2;2019:7820971. doi: 10.1155/2019/7820971. eCollection 2019.

    PubMed 31275636

  • Chan EW, Li X, Tham YC, Liao J, Wong TY, Aung T, Cheng CY. Glaucoma in Asia: regional prevalence variations and future projections. Br J Ophthalmol. 2016 Jan;100(1):78-85. doi: 10.1136/bjophthalmol-2014-306102. Epub 2015 Jun 25.

    PubMed 26112871

  • Holly FJ, Lamberts DW, Esquivel ED. Kinetics of capillary tear flow in the Schirmer strip. Curr Eye Res. 1982;2(1):57-70. doi: 10.3109/02713688208998380.

    PubMed 7128183

  • Miyake H, Kawano Y, Tanaka H, Iwata A, Imanaka T, Nakamura M. Tear volume estimation using a modified Schirmer test: a randomized, multicenter, double-blind trial comparing 3% diquafosol ophthalmic solution and artificial tears in dry eye patients. Clin Ophthalmol. 2016 May 13;10:879-86. doi: 10.2147/OPTH.S105275. eCollection 2016.

    PubMed 27257372

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Open-angle Glaucoma and Primary Angle-Closure Glaucoma, run by Santen Pharma Malaysia Sdn Bhd.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dr. Gan (603-22848989, ganenghui@yahoo.com.my), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fluorescein staining score (NEI/I) (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04609345, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.

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