NCT04609345

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

October 20, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

5 months

First QC Date

October 20, 2020

Last Update Submit

October 25, 2020

Conditions

Primary Open-angle GlaucomaPrimary Angle-Closure GlaucomaPseudoexfoliation GlaucomaPigment Dispersion GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (4)

  • 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.

    1 day

  • 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.

    1 day

  • 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.

    1 day

  • Schirmer's score

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

    1 day

Secondary Outcomes (2)

  • Symptom Evaluation

    1 day

  • Questionnaire feedback

    1 day

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \) Age of 21 years or older and those who can provide informed consent.
  • \) On anti-glaucoma medications for \>6 months
  • \) IOP ≤ 21 mm Hg in the study eye at the screening examination (under treatment)
  • \) 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.
  • \) A best-corrected visual acuity score of 6/36 on the Snellen Chart, or better in each eye.

You may not qualify if:

  • \) Those with secondary ocular hypertension or glaucoma
  • \) Those with severe visual field disorder (mean deviation of 20 dB or worse)
  • \) 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.
  • \) Those with a history of glaucoma surgery
  • \) Those with a history of corneal refractive surgery
  • \) Those with severe dry eye associated with systemic disorders, or in need of drugs to treat dry eye
  • \) Those with ocular allergy, ocular infection or ocular inflammation
  • \) Those using eye drops for other ocular comorbidities
  • \) Those who need to use systemic or ophthalmic steroids (excluding topical skin steroidal ointment)
  • \) Female patients who are pregnant, nursing or lactating
  • \) Those who use contact lenses
  • \) Any corneal abnormality or other corneal comorbidity condition preventing reliable applanation tonometry
  • \) Those on oral antihistamine, antipsychotic or anti-depressant drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (16)

  • 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.

    PMID: 27895937BACKGROUND

  • 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.

    PMID: 28577860BACKGROUND

  • 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.

    PMID: 28497458BACKGROUND

  • 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.

    PMID: 23714318BACKGROUND

  • 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.

    PMID: 25863853BACKGROUND

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

    PMID: 24872675BACKGROUND

  • 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.

    PMID: 25730335BACKGROUND

  • 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.

    PMID: 22536034BACKGROUND

  • 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.

    PMID: 24305504BACKGROUND

  • 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.

    PMID: 30364180BACKGROUND

  • 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.

    PMID: 21636966BACKGROUND

  • 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.

    PMID: 31275636BACKGROUND

  • 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.

    PMID: 26112871BACKGROUND

  • 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.

    PMID: 7128183BACKGROUND

  • 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.

    PMID: 27257372BACKGROUND

  • Bourne RRA, Kaarniranta K, Lorenz K, Traverso CE, Vuorinen J, Ropo A. Changes in ocular signs and symptoms in patients switching from bimatoprost-timolol to tafluprost-timolol eye drops: an open-label phase IV study. BMJ Open. 2019 Apr 2;9(4):e024129. doi: 10.1136/bmjopen-2018-024129.

    PMID: 30944129BACKGROUND

Related Links

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma, Angle-ClosureExfoliation SyndromeOcular Hypertension

Condition Hierarchy (Ancestors)

GlaucomaEye DiseasesIris DiseasesUveal Diseases

Study Officials

  • Eng Hui Gan, Specialist

    International Specialist Eye Centre (ISEC)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Gan

CONTACT

603-22848989ganenghui@yahoo.com.my

Veni

CONTACT

603-22763333veni.venusha.sakti@santen.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 20, 2020

First Posted

October 30, 2020

Study Start

November 1, 2020

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

October 30, 2020

Record last verified: 2020-10