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

Last updated: November 23, 2020
Sponsor: CHA University
Overall Status: Active - Not Recruiting

Phase

4

Condition

Glaucoma

Treatment

N/A

Clinical Study ID

NCT04647461
BAT
  • Ages > 19
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. Patients with primary closed-angle glaucoma, congenital glaucoma and secondaryglaucoma 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 orwho 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 thetreatment or safety of this clinical trial. Patients that other researchers aredetermined inadequately

Study Design

Total Participants: 61
Study Start date:
March 20, 2019
Estimated Completion Date:
January 29, 2021

Study 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)

Connect with a study center

  • CHA University Bundang Medical Center

    Seongnam, Bundang-gu 13497
    Korea, Republic of

    Site Not Available

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