Clinical trial NCT06078592: Comparison of Efficacy and Ocular Surface Assessment Between BRIDIN-plus and Combigan in Glaucoma or Ocular Hypertensive
Official title: Comparison of Efficacy and Ocular Surface Disease Assessment Between BRIDIN- PLUS® Eye Drops and COMBIGAN® Eye Drops in Glaucoma or Ocular Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertensive
Lead sponsor: CHA University
Sponsor class: OTHER
Collaborators: name: Hanlim Pharm. Co., Ltd.
First posted: 2023-10-12
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of Efficacy and Ocular Surface Disease Assessment between BRIDIN-plus Eye drops and Combigan Eye drops in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial

Detailed description: The purpose of this clinical trial is to prove lower negative effects on ocular surface disease and higher patient compliance of a single-use formula BRIDIN-PLUS® eye drops group, comparing to a multi-use formula COMBIGAN® eye drops after 12 weeks of administration to glaucoma or ocular hypertensive patients.

Eligibility criteria: Inclusion Criteria

1. Male or female adults who are 19 years or older with a diagnosis of glaucoma or intraocular hypertension
2. A person who has completed an appropriate washout period if glaucoma treatment medication has been used
3. Intraocular pressure measured by Goldman applanation tonometer at visit 2 is 15mmHg or above and less than 40mmHg
4. A person who has signed the written consent form by himself/herself or by a legal representative

Exclusion Criteria:

1. A patient with primary close angle glaucoma, congenital glaucoma, secondary glaucoma caused by steroids
2. Best corrected visual acuity of both eyes measured by Snellen acuity charts is 20/80 (decimal 0.25) or less
3. A patient with progressive intraocular inflammation
4. Central corneal thickness is less than 470um or greater than 591ums
5. A patient who has had lacrimal punctual occlusion done within the last 3 monthds or who has eye surgery plan during the clinical study
6. Pregnant or lactating women
7. Other cases if investigators judge the patient is difficult to participate the clinical trial

Primary outcomes:
measure: Corneal staining test
timeFrame: 12 weeks after administration
measure: Conjunctival staining test
timeFrame: 12 weeks after administration
measure: Ocular surface disease index (OSDI)
timeFrame: 12 weeks after administration
measure: Questionnaire (Evaluation of Satisfaction with Medication, Ocular tolerance)
timeFrame: 12 weeks after administration
Secondary outcomes:
measure: Corneal staining test
timeFrame: 4 weeks after administration
measure: Conjunctival staining test
timeFrame: 4 weeks after administration
measure: Ocular surface disease index (OSDI)
timeFrame: 4 weeks after administration
measure: IOP(Intraocular pressure)
timeFrame: 4, 12 weeks after administration
measure: Tear break up time (TBUT)
timeFrame: 4, 12 weeks after administration
measure: Hyperemia score
timeFrame: 4, 12 weeks after administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seungsoo Rho
state: Seongnam, Bundang-gu
Study officials:
affiliation: CHA Bundang Medical Center
name: Seungsoo Rho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: