A randomized multicenter clinical evaluation of sequential application of 0.3% and 0.15% hyaluronic acid for treatment of dry eye
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0004214
- Lead Sponsor
- Keimyung University Dongsan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
Individuals aged 19 or over who presented with the following criteria after usage of 0.15% HA in the run-in period were enrolled: bilateral DED no less than level 2, tear break-up time (TBUT) less than 10 seconds, corneal fluorescein staining (CFS) score of at least 1 or more by the National Eye Institute (NEI/Industry) grading system, and 33 or more ocular surface disease index (ODSI) severity scale.
At the baseline examination, patients with mild DED (level 1), TBUT >10 seconds, CFS score <1, and ODSI score <33 (at end of run-in period) were excluded. Patients with previous ocular pathologies requiring treatment, previous corneal or intraocular surgery within 6 months of the screening visit, a punctal occlusion procedure within 1 month of the screening visit, use of soft contact lenses during the study, measured intraocular pressure over 25 mmHg at the screening visit, and a significant hypersensitivity reaction to HA, as well as patients who were pregnant, breastfeeding, or planning to become pregnant were also excluded.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Corneal staining score
- Secondary Outcome Measures
Name Time Method tear break-up time