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

NCT04647461 | Unknown Phase 4

• 1 other identifier: BAT
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Conditions

Glaucoma; Ocular Hypertensive

Outcome Measures

Primary Outcomes (4)

• Corneal staining test

  The degree of staining of the cornea after blue fluorescein staining under the slit lamp illumination of a cobalt blue light source using a yellow filter was evaluated on a 6 point scale according to the oxford grading system

  Administered 12 weeks after

• Conjunctival staining test

  After lysamine green staining under slit lamps, the conjunctiva was divided into the nasal side and the lateral side, and the degree of nasal conjunctiva and bilateral conjunctival staining was evaluated on a 6-point scale according to the oxford grading system

  Administered 12 weeks after

• Ocular surface disease index (OSDI)

  The ocular surface disease index was assessed for ocular surface disease, including visual function (five items), eye symptoms (four items), and environmental factors (three items) , 0 point for no symptoms, 1 point for occasional symptoms, 2 points for symptoms of half a day, 3 points for most symptoms, and 4 points for symptoms during the whole day.

  Administered 12 weeks after

• Questionnaire (Evaluation of Satisfaction with Medication, Ocular tolerance)

  The evaluation of satisfaction with medication is conducted with a questionnaire evaluation on the convenience of use, storage of investigational product, and the ocular tolerance. Evaluation is conducted on 8 symptoms of tingling/hot, sticky, itchy, blurred vision, foreign body sensation, dryness, glare, and pain. Assess the severity of symptoms (0-3 points) and duration of symptoms (immediate, continuous)

  Administered 12 weeks after

Secondary Outcomes (6)

• Corneal staining test

  Administered 4 weeks after

• Conjunctival staining test

  Administered 4 weeks after

• Ocular surface disease index (OSDI)

  Administered 4 weeks after

• IOP(Intraocular pressure)

  Administered 4, 12 weeks after

• Tear break up time (TBUT)

  Administered 4, 12 weeks after

Study Arms (2)

BRIDIN-T Eye drops 0.15%(Non preservative)

EXPERIMENTAL

Brimonidine Tartrate 1.5mg : 1 drop 3 times a day for 12 weeks to target eyes

Drug: Brimonidine Tartrate 1.5mg

ALPHAGAN-P Eye drops 0.15%(Preservatives)

ACTIVE COMPARATOR

Brimonidine Tartrate 1.5mg : 1 drop 3 times a day for 12 weeks to target eyes

Drug: Brimonidine Tartrate 1.5mg

Interventions

Brimonidine Tartrate 1.5mg DRUG

1 drop 3 times a day for 12 weeks to target eyes

Also known as: BRIDIN-T Eye drops 0.15%

BRIDIN-T Eye drops 0.15%(Non preservative)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult(Male or Female) over 19 years who were diagnosed with glaucoma or ocular hypertension
• 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.
• Intraocular pressure (IOP) \>/= 15mmHg and \< 40mmHg in each eye using Goldmann applanation tonometry at visit 2
• Written consent voluntarily to participate in this clinical trial

You may not qualify if:

• Patients with primary closed-angle glaucoma, congenital glaucoma and secondary glaucoma caused by steroid drugs, etc.
• BCVA (best-corrected visual acuity) Snellen equivalent of Snellen 20/80(logMar 0.25) or less.
• Those who have ongoing medical history as intraocular inflamation.
• Central corneal thickness is not between 470um and 591um.
• Patients who have received lacrimal passive occlusion within the last three months or who have surgery plans during the clinical trial period.
• Pregnant or nursing women.
• 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

Sponsors & Collaborators

• CHA University: lead
• Hanlim Pharm. Co., Ltd.: collaborator

Study Sites (1)

CHA University Bundang Medical Center

Seongnam, Bundang-gu, 13497, South Korea

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor., M.D., Ph.D.

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 1, 2020
• Study Start: March 20, 2019
• Primary Completion: January 29, 2021
• Study Completion: January 29, 2021
• Last Updated: December 1, 2020

Record last verified: 2020-11

Locations

KR (1)