A randomized multicenter clinical evaluation of sequential application of 0.3% and 0.15% hyaluronic acid for treatment of dry eye

Ocular surface changes after combination therapy of hyaluronate 0.15% and hyaluronate 0.3% in dry eye patients.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0004214

Enrollment

Registered

2019-08-19

Start date

2017-10-01

Completion date

Unknown

Last updated

2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Ninety patients were randomly assigned to the 0.15&#37

HA group (n=30), 0.3&#37

HA group (n=30), or combination group (n=30). Each group applied two drops of 0.15&#37

or 0.3&#37

HA, or a single drop of both 0.3&#37

and 0.15&#37

HA. Patients were evaluated using the ocular surface disease index (OSDI), CFS and conjunctival fluorescein stain score, TBUT, and blurring/discomfort after application at baseline, 4 weeks, and 8 wee

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Corneal staining score	—

Secondary

Measure	Time frame
tear break-up time	—

Countries

Korea, Republic of

Contacts

Public ContactJONG HWA JUN

Keimyung University Dongsan Medical Center

junjonghwa@gmail.com@junjonghwa@gmail.com+82-53-258-4545

Outcome results