Effectiveness of Diquafosol Prophylactic Therapy to Prevent Dry Eye Disease for Cataract Surgery Patients in Indonesia
NCT ID: NCT06146881
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
70 participants
INTERVENTIONAL
2022-10-02
2024-03-15
Brief Summary
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* 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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Diquafosol sodium 3% group
Diquafosol sodium 3% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery
Diquafosol sodium 3%
Diquafosol sodium 3% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery
Sodium hyaluronate 0.1% group
Sodium hyaluronate 0.1% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery
Sodium hyaluronate 0.1%
Sodium hyaluronate 0.1% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery
Interventions
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Diquafosol sodium 3%
Diquafosol sodium 3% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery
Sodium hyaluronate 0.1%
Sodium hyaluronate 0.1% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery
Eligibility Criteria
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Inclusion Criteria
2. Patients with dry eye disease
3. Patients are willing to participate in the study and fill out informed consent
Exclusion Criteria
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
ALL
No
Sponsors
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Santen Pharmaceutical Co., Ltd.
INDUSTRY
Indonesia University
OTHER
Responsible Party
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Prof. Dr. dr. Ratna Sitompul, Sp.M(K)
Prof. Dr. dr. Ratna Sitompul, Sp.M(K)
Locations
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RSUPN Dr. Cipto Mangunkusumo
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Countries
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Central Contacts
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Facility Contacts
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RSUPN Dr. Cipto Mangunkusumo
Role: primary
Other Identifiers
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21050581
Identifier Type: -
Identifier Source: org_study_id