Completed
Randomized Controlled Trial of the Effects of Sodium Hyaluronate on Wavefront Aberrations in Dry Eye Patients
What is being tested
0.18% sodium hyaluronate
+ 0.9% sodium chloride solution
Drug
Who is being recruted
Eye Diseases
+ Lacrimal Apparatus Diseases
+ Dry Eye Syndromes
+16 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-Controlled
Interventional
Study Start: January 2007
Summary
Principal SponsorRamathibodi Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2007
Actual date on which the first participant was enrolled.Parameters used to determine treatment outcomes included ocular aberrations and severity of dry eye symptoms.
Official TitleRandomized Controlled Trial of the Effects of Sodium Hyaluronate on Wavefront Aberrations in Dry Eye Patients
Principal SponsorRamathibodi Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Eye DiseasesLacrimal Apparatus DiseasesDry Eye Syndromes
Criteria
5 inclusion criteria required to participate
Male or female patients aged 18 years or over.
Documented history of bilateral dry eye for at least 3 months.
Schirmer's I test (without anesthesia) less than 10 mm wetting/5 minutes for each eye.
Tear film break-up time (TBUT) less than 10 seconds for each eye.
Show More Criteria
11 exclusion criteria prevent from participating
Pregnant or lactating women.
Contact lens wear.
Non-mydriatic pupil size less than 5.0 mm.
Other ocular surface pathologies or coexisting ocular diseases.
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalOne drop of preservative-free, hypotonic 0.18% sodium hyaluronate in one eye
Group II
Placeboone drop of sterile 0.9% sodium chloride solution in the other eye
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center