Clinical trial NCT04647461: Comparison of Efficacy and Ocular Surface Disease Assessment Between BRIDIN-T Eye Drops 0.15% and ALPHAGAN-P Eye Drops 0.15% in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial
Official title: Comparison of Efficacy and Ocular Surface Disease Assessment Between BRIDIN-T Eye Drops 0.15% and ALPHAGAN-P Eye Drops 0.15% in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertensive
Lead sponsor: CHA University
Sponsor class: OTHER
Collaborators: name: Hanlim Pharm. Co., Ltd.
First posted: 2020-12-01
Enrollment: 61
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-T Eye drops 0.15% and ALPHAGAN-P Eye drops 0.15% in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial

Detailed description: Following 12 weeks of administration of BRIDIN-T Eye drops 0.15%(non preservative) or ALPHAGAN-P Eye drops 0.15%(preservatives) for patients with glaucoma or Ocular Hypertensive Patients. The use of BRIDIN-T Eye drops(non preservative) is less harmful to external ophthalmicus diseases and increase of medication compliance for ophthalmic drugs than the ALPHAGAN-P Eye drops 0.15%(preservatives)

Eligibility criteria: Inclusion Criteria:

1. Adult(Male or Female) over 19 years who were diagnosed with glaucoma or ocular hypertension
2. In the case of a person receiving a glaucoma treatment drug, a person who has completed the appropriate in wash-out period for the existing glaucoma drug before the investigational product is administered.
3. Intraocular pressure (IOP) \>/= 15mmHg and \< 40mmHg in each eye using Goldmann applanation tonometry at visit 2
4. Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

1. Patients with primary closed-angle glaucoma, congenital glaucoma and secondary glaucoma caused by steroid drugs, etc.
2. BCVA (best-corrected visual acuity) Snellen equivalent of Snellen 20/80(logMar 0.25) or less.
3. Those who have ongoing medical history as intraocular inflamation.
4. Central corneal thickness is not between 470um and 591um.
5. Patients who have received lacrimal passive occlusion within the last three months or who have surgery plans during the clinical trial period.
6. Pregnant or nursing women.
7. Patients judged coexisting disease that could interfere with the completion of the treatment or safety of this clinical trial. Patients that other researchers are determined inadequately

Primary outcomes:
measure: Corneal staining test
timeFrame: Administered 12 weeks after
measure: Conjunctival staining test
timeFrame: Administered 12 weeks after
measure: Ocular surface disease index (OSDI)
timeFrame: Administered 12 weeks after
measure: Questionnaire (Evaluation of Satisfaction with Medication, Ocular tolerance)
timeFrame: Administered 12 weeks after
Secondary outcomes:
measure: Corneal staining test
timeFrame: Administered 4 weeks after
measure: Conjunctival staining test
timeFrame: Administered 4 weeks after
measure: Ocular surface disease index (OSDI)
timeFrame: Administered 4 weeks after
measure: IOP(Intraocular pressure)
timeFrame: Administered 4, 12 weeks after
measure: Tear break up time (TBUT)
timeFrame: Administered 4, 12 weeks after
measure: Slit Lamp Biomicroscopy Findings - Limbal Redness
timeFrame: Administered 4, 12 weeks after
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: CHA University Bundang Medical Center
state: Bundang-gu
Study officials:
References: