Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560580
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Ditefossol Sodium 3 Eye Drops in Patients With Dry Eye
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Efficacy of 3 Diquafosol Sodium Eye Drops in Dry Eye Patients Across Age Groups a Propensity Score-Matched Longitudinal Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aimed to evaluate the efficacy of 3 diquafosol sodium eye drops in treating dry eye disease DED across different age groups using a propensity score-matched longitudinal design
Detailed Description:
1 Participants and Study Design
This prospective clinical trial was conducted following ethical principles and received approval from the Ethics Committee of Tianjin Eye Hospital of China Approval No TJYYLCSYSCLL-2021-25 The study adhered to the tenets of the Declaration of Helsinki and all patients provided written informed consent after receiving a detailed explanation of the study protocols and the potential consequences associated with participation
Inclusion Criteria Patients with Dry Eye Disease DED were eligible if they met one of the following criteria
1 They reported symptoms such as dryness foreign body sensation burning fatigue discomfort redness or fluctuating vision with a Chinese dry eye questionnaire score DEQS 7 Additionally they had either a fluorescein tear breakup time FBUT 5 s a non-invasive tear breakup time NIBUT 10 s or a Schirmer I test without anesthesia 5 mm5 min
2 They had dry eye-related symptoms with a Chinese DEQS 7 Additionally they had either FBUT 5 s and 10 s NIBUT between 10 and 12 s or a Schirmer I test without anesthesia 5 mm5 min and 10 mm5 min Furthermore patients were required to have positive fluorescein staining 5 spots for diagnosis
Exclusion Criteria Excluded were patients with allergies to any component of the drugs or diagnostic agents used those who had used 3 diquafosol sodium eye drops within 2 weeks before enrollment any systemic conditions affecting ocular medication and corneal disorders preventing diagnostic tests such as keratitis and corneal dystrophy The exclusion criteria also included concurrent use of ocular or systemic NSAIDs steroids or immunosuppressants recent use of eye drops recent physical therapy or ocular surgery recent contact lens wear punctual plug treatment independent ocular diseases requiring additional treatment and pregnant or breastfeeding women or those planning to become pregnant All female patients of childbearing age tested negative in a urine pregnancy test before enrollment If both eyes met the inclusion criteria the eye with the shorter FBUT was selected If both eyes had the same FBUT the right eye was selected
Patients were divided into two groups based on age the younger group 40 years and the older group 40 years Propensity Score Matching PSM 11 was used to ensure no significant differences in baseline characteristics between the two groups The study design aimed to evaluate the efficacy of 3 diquafosol eye drops in patients with dry eye across different age groups Patients were followed up at baseline V1 1 month V2 and 3 months V3 with examinations including DEQS visual acuity VA lipid layer thickness tear meniscus height TMH meibomian gland dropout area MGDA FBUT Schirmer I test and intraocular pressure IOP
2 Treatment and Examinations
Each patient was prescribed 3 diquafosol sodium eye drops to be instilled one drop six times daily for 3 months Follow-up examinations were conducted at baseline 1 month and 3 months after treatment initiation
The first visit and follow-up examinations included VA IOP FBUT Schirmer I test TMH MGDA DEQS and lipid layer thickness The following sequence was used to avoid interference between the tests
1 Dry Eye Questionnaire Score DEQS DEQS was administered first to assess subjective symptoms of dry eye Patients completed a questionnaire evaluating discomfort and the impact of dry eyes on daily life with scores calculated using a standardized DEQS scoring system
2 Visual Acuity VA VA was measured using a 5 m standard Snellen chart and recorded in decimal notation VA was converted to the Logarithm of the Minimum Angle of Resolution LogMAR format for statistical analysis
3 Lipid Layer Thickness Lipid layer thickness was evaluated using a LipiView interferometer based on the principle of white-light interference
4 Tear Meniscus Height TMH TMH was measured using an ocular surface analyzer which captured images of the tear meniscus at the lower eyelid margin to assess tear volume
5 Meibomian Gland Dropout Area MGDA MGDA was examined using an ocular surface analyzer Infrared imaging visualized the meibomian glands in the eyelids and the extent of gland dropout was quantified using ImageJ software
6 Fluorescein Tear Breakup Time FBUT FBUT was measured by instilling fluorescein dye into the conjunctival sac and recording the time from the last blink to the first appearance of a dry spot on the corneal surface using a slit-lamp biomicroscope
7 Schirmer I Test Schirmer I test was performed without anesthesia Standardized Schirmer strips were placed at the junction of the middle and lateral thirds of the lower eyelid margins for 5 min Wetting length on the strip was measured in millimeters
8 Intraocular Pressure IOP IOP was measured using a non-contact tonometer which delivered a puff of air to the cornea to calculate the IOP Three measurements were taken for each eye and the average IOP was recorded
By following this sequence and using standardized methods the study ensured a reliable and reproducible assessment of the efficacy of 3 diquafosol eye drops in patients with dry eyes
This prospective clinical trial was conducted following ethical principles and received approval from the Ethics Committee of Tianjin Eye Hospital of China Approval No TJYYLCSYSCLL-2021-25 The study adhered to the tenets of the Declaration of Helsinki and all patients provided written informed consent after receiving a detailed explanation of the study protocols and the potential consequences associated with participation
Inclusion Criteria Patients with Dry Eye Disease DED were eligible if they met one of the following criteria
1 They reported symptoms such as dryness foreign body sensation burning fatigue discomfort redness or fluctuating vision with a Chinese dry eye questionnaire score DEQS 7 Additionally they had either a fluorescein tear breakup time FBUT 5 s a non-invasive tear breakup time NIBUT 10 s or a Schirmer I test without anesthesia 5 mm5 min
2 They had dry eye-related symptoms with a Chinese DEQS 7 Additionally they had either FBUT 5 s and 10 s NIBUT between 10 and 12 s or a Schirmer I test without anesthesia 5 mm5 min and 10 mm5 min Furthermore patients were required to have positive fluorescein staining 5 spots for diagnosis
Exclusion Criteria Excluded were patients with allergies to any component of the drugs or diagnostic agents used those who had used 3 diquafosol sodium eye drops within 2 weeks before enrollment any systemic conditions affecting ocular medication and corneal disorders preventing diagnostic tests such as keratitis and corneal dystrophy The exclusion criteria also included concurrent use of ocular or systemic NSAIDs steroids or immunosuppressants recent use of eye drops recent physical therapy or ocular surgery recent contact lens wear punctual plug treatment independent ocular diseases requiring additional treatment and pregnant or breastfeeding women or those planning to become pregnant All female patients of childbearing age tested negative in a urine pregnancy test before enrollment If both eyes met the inclusion criteria the eye with the shorter FBUT was selected If both eyes had the same FBUT the right eye was selected
Patients were divided into two groups based on age the younger group 40 years and the older group 40 years Propensity Score Matching PSM 11 was used to ensure no significant differences in baseline characteristics between the two groups The study design aimed to evaluate the efficacy of 3 diquafosol eye drops in patients with dry eye across different age groups Patients were followed up at baseline V1 1 month V2 and 3 months V3 with examinations including DEQS visual acuity VA lipid layer thickness tear meniscus height TMH meibomian gland dropout area MGDA FBUT Schirmer I test and intraocular pressure IOP
2 Treatment and Examinations
Each patient was prescribed 3 diquafosol sodium eye drops to be instilled one drop six times daily for 3 months Follow-up examinations were conducted at baseline 1 month and 3 months after treatment initiation
The first visit and follow-up examinations included VA IOP FBUT Schirmer I test TMH MGDA DEQS and lipid layer thickness The following sequence was used to avoid interference between the tests
1 Dry Eye Questionnaire Score DEQS DEQS was administered first to assess subjective symptoms of dry eye Patients completed a questionnaire evaluating discomfort and the impact of dry eyes on daily life with scores calculated using a standardized DEQS scoring system
2 Visual Acuity VA VA was measured using a 5 m standard Snellen chart and recorded in decimal notation VA was converted to the Logarithm of the Minimum Angle of Resolution LogMAR format for statistical analysis
3 Lipid Layer Thickness Lipid layer thickness was evaluated using a LipiView interferometer based on the principle of white-light interference
4 Tear Meniscus Height TMH TMH was measured using an ocular surface analyzer which captured images of the tear meniscus at the lower eyelid margin to assess tear volume
5 Meibomian Gland Dropout Area MGDA MGDA was examined using an ocular surface analyzer Infrared imaging visualized the meibomian glands in the eyelids and the extent of gland dropout was quantified using ImageJ software
6 Fluorescein Tear Breakup Time FBUT FBUT was measured by instilling fluorescein dye into the conjunctival sac and recording the time from the last blink to the first appearance of a dry spot on the corneal surface using a slit-lamp biomicroscope
7 Schirmer I Test Schirmer I test was performed without anesthesia Standardized Schirmer strips were placed at the junction of the middle and lateral thirds of the lower eyelid margins for 5 min Wetting length on the strip was measured in millimeters
8 Intraocular Pressure IOP IOP was measured using a non-contact tonometer which delivered a puff of air to the cornea to calculate the IOP Three measurements were taken for each eye and the average IOP was recorded
By following this sequence and using standardized methods the study ensured a reliable and reproducible assessment of the efficacy of 3 diquafosol eye drops in patients with dry eyes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None