Effectiveness of Diquafosol Prophylactic Therapy to Prevent Dry Eye Disease for Cataract Surgery Patients in Indonesia

The Indonesian Research on Survey and Treatment for Dry Eye Disease (ThIRST DED): Effectiveness of Diquafosol Prophylactic Therapy to Prevent Dry Eye Disease for Cataract Surgery Patients in Indonesia

The goal of this clinical trial is to determine the effectiveness of preventive therapy with diquafosol sodium 3% compared to sodium hyaluronate 0.1% to prevent dry eye disease in patient who will undergo cataract surgery. The main questions it aims to answer are:

• The percentage reduction in subjective symptoms and signs of dry eye disease after cataract surgery.
• The differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs in patients objectively.
• The tear osmolarity and matix metalloproteinase-9 (MMP-9) after the treatment.
• The difference in visual quality improvement assessed from higher order aberrations (HOA) and contrast sensitivity after administration of diquafosol sodium 3% compared to sodium hyaluronate 0.1%.

Participants will receive diquafosol sodium 3% or sodium hyaluronate 0.1% for 4 weeks before the cataract surgery and 21 days after the surgery, and will be:

• Interviewed regarding their identity, history of illness, and symptoms of dry eye disease.
• Examined by researchers: eye condition, contrast sensitivity using the Pelli-Robson diagram, keratograph, HOA, tear osmolarity, MMP-9, corneal sensitivity, tear break up time (TBUT) , fluorescein break up pattern (FBUP).

This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: Diquafosol sodium 3%; Drug: Sodium hyaluronate 0.1%

Detailed Description

The general objective of this study is to determine the effectiveness of preventive therapy with diquafosol sodium 3% compared to sodium hyaluronate 0.1% for patient who will undergo cataract surgery. The objective is being measure by the reducing symptoms and milder signs of dry eye disease and improving vision quality in post-cataract surgery patients.

1. Evaluate the percentage reduction in subjective symptoms and signs of dry eye disease after cataract surgery with diquafosol sodium 3% compared to sodium hyaluronate 0.1% in patients who want to undergo cataract surgery.
2. Evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs in patients objectively by examining the value of break up time, corneal sensibility, keratograph and FBUP
3. Evaluate tear osmolarity and MMP-9 after administration of diquafosol sodium 3% compared to sodium hyaluronate 0.1%
4. Evaluate the difference in visual quality improvement assessed from HOA and contrast sensitivity after administration of diquafosol sodium 3% compared to sodium hyaluronate 0.1%

Participants will receive diquafosol sodium 3% or sodium hyaluronate 0.1% for 4 weeks before the cataract surgery and 21 days after the surgery.

The steps of the research examination are as follows:

A) History

• Comorbid dry eye disease and screening exclusion criteria (history of smoking, previous medical history, history of hypertension, history of diabetes mellitus, history of routine medication and history of recent surgery)
• Ocular Surface Disease Index (OSDI) Questionnaire

B) Physical Examination

The examination is carried out with sufficient lighting, to see if the patient's eye has other eye surface disorders that can affect dry eye syndrome. Examination of disorders of the surface of the eyeball is carried out by inspection to see the patient's ability to blink, the eyelids, eyelashes and interpalpebral surface, performing an examination by lifting the upper upper eyelid superiorly, examination by pulling the eyelid to see if the eyelid looks drooping and checking In the fornix of the eye, emphasis is placed on the expression of the meibomian glands. The existence of a positive examination, describes the patient has a disorder of the eyeball surface. This examination determines whether the patient can undergo cataract surgery for research.

C) Supporting Examination

- Contrast sensitivity using the Pelli-Robson diagram, keratograph, HOA, tear osmolarity, MMP-9, corneal sensitivity, tear break up time, fluorescein break up pattern.

This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Natasya Claudia Santoso; Phone Number: +6282132348778; Email: thristded@gmail.com

Study Locations

• Indonesia
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia, 10430
      • Recruiting
      • RSUPN Dr. Cipto Mangunkusumo
      • Contact: RSUPN Dr. Cipto Mangunkusumo; Phone Number: +213148991

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Cataract patients who will undergo phacoemulsification procedures and intraocular lens (IOL) implants
2. Patients with dry eye disease
3. Patients are willing to participate in the study and fill out informed consent

Exclusion Criteria:

1. Subjects with lacrimal gland or eyelid disorders (ptosis, blepharospasm, lagophthalmos, entropion, ectropion, and blepharitis)
2. There are complications after cataract surgery
3. Patients with a history of using topical medications / eye drops that are used routinely
4. History of eye surgery in the last 6 months
5. Serious ocular surface disorders (Sjögren syndrome, pemphigoid, chemical trauma)
6. Using regular medication that trigger dry eye conditions (eg antihistamines, antidepressants, decongestants, anticholinergics) / allergy to diquafosol drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diquafosol sodium 3% group; Diquafosol sodium 3% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery	Drug: Diquafosol sodium 3%; Diquafosol sodium 3% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery
Active Comparator: Sodium hyaluronate 0.1% group; Sodium hyaluronate 0.1% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery	Drug: Sodium hyaluronate 0.1%; Sodium hyaluronate 0.1% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OSDI questionnaire score	This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients subjectively with OSDI questionnaire. The OSDI score results will be assessed. Lower scores mean a better outcome. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.	4 months
Tear break up time value	This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the value of tear break up time. Higher value in tear break up time mean a better outcome. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.	4 months
Fluorescein break up pattern	This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the fluorescein break up pattern. The fluorescein break up pattern results will be categorized and analyzed descriptively. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.	4 months
Corneal sensibility using Cochet Bonnet esthesiometer	This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the value of corneal sensibility using cochet bonnet esthesiometer. Any changes to the value will be assessed. Higher value mean a better outcome. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.	4 months
Tear osmolarity using TearLab device	This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients subjectively objectively by examining the value of tear osmolarity using TearLab device. Lower value mean a better outcome. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.	4 months
Higher Order Aberrations (HOA) value using oculyzer device	This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the value of Higher Order Aberrations (HOA) using oculyzer device to assess the corneal aberrations. Lower value mean a better outcome. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.	4 months
Contrast sensitivity value using Pelli-Robson Contrast Sensitivity Chart	This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the value of contrast sensitivity using Pelli-Robson Contrast Sensitivity Chart. Higher value mean a better outcome. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.	4 months
Matrix metalloproteinase-9 value using Human MMP-9 ELISA Kit	This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the value of matrix metalloproteinase-9 using Human MMP-9 ELISA Kit. Lower value mean a better outcome. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.	4 months
Keratograph device to assess tear meniscus height, noninvasive keratograph tear break up time (NIKBUT), and redness	This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients subjectively objectively by examining the patients using keratograph device to assess the tear meniscus height, noninvasive keratograph tear break up time (NIKBUT), and redness. The results will be categorized and analyzed descriptively. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.	4 months

Collaborators and Investigators

• Sponsor: Indonesia University
• Collaborators: Santen Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2022
• Primary Completion (Estimated): December 15, 2023
• Study Completion (Estimated): March 15, 2024

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 24, 2023
• First Posted (Actual): November 27, 2023

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Dry eye disease
• Additional Relevant MeSH Terms: Lens Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Cataract; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 21050581

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No