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Comparison of Efficacy and Ocular Surface Disease Assessment Between Monoprost and BAK-preserved Latanoprost

Sponsor
CHA University (Other)
Overall Status
Completed
CT.gov ID
NCT04743622
Collaborator
Samil Pharmaceutical Co., Ltd. (Industry)
57
Enrollment
1
Location
2
Arms
16.5
Actual Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparison of Efficacy and Ocular Surface Disease Assessment Between Monoprost and BAK-preserved Latanoprost in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Study

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Not provided

Study Design

Study Type:
Interventional
Actual Enrollment :
57 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Comparison of Efficacy and Ocular Surface Disease Assessment Between Monoprost and BAK-preserved Latanoprost in Glaucoma or Ocular Hypertensive Patients
Actual Study Start Date :
Apr 30, 2019
Actual Primary Completion Date :
Jun 23, 2020
Actual Study Completion Date :
Sep 13, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Monoprost (preservative-free latanoprost eye drop)

latanoprost : 1 drop once a day for 12 weeks to target eyes

Drug: Monoprost
preservative-free latanoprost 1 drop once a day for 12 weeks to target eyes
Other Names:
  • Preservative-free latanoprost

    		•
    Active Comparator: Xalatan (preserved latanoprost eye drop)

    latanoprost : 1 drop once a day for 12 weeks to target eyes

    Drug: Xalatan
    preserved latanoprost 1 drop once a day for 12 weeks to target eyes
    Other Names:
  • Preserved latanoprost

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Corneal staining test [(12-week-point)]

      The degree of staining of the cornea after blue fluorescein staining under the light of cobalt blue using a yellow filter was evaluated according to the Oxford grading system (0 to 5, the higher the worse)

    2. Conjunctival staining test [(12-week-point)]

      The conjunctiva was divided into 6 areas and evaluated after the same staining method according to the Oxford grading system (0 to 3, the higher the worse)

    3. Ocular surface disease index (OSDI) [(12-week-point)]

      The ocular surface was assessed using OSDI scoring questionnaire (0 to 100, the higher the worse)

    4. Compliance check [(12-week-point)]

      Compliance of the drug administration has been check through the subject's self description (0 to 100, the higher the better)

    Secondary Outcome Measures

    1. Corneal staining test [(4-week-point)]

      The degree of staining of the cornea after blue fluorescein staining under the light of cobalt blue using a yellow filter was evaluated according to the Oxford grading system(0 to 5, the higher the worse)

    2. Conjunctival staining test [(4-week-point)]

      The conjunctiva was divided into 6 areas and evaluated after the same staining method according to the Oxford grading system (0 to 3, the higher the worse)

    3. Ocular surface disease indext (OSDI) [(4-week-point)]

      The ocular surface was assessed using OSDI scoring questionnaire(0 to 100, the higher the worse)

    4. IOP (intraocular pressure) [(4- / 12-week-point)]

      IOP was measured using Goldmann applanation tonometry and measured in mmHg. (numerical)

    5. Tear break up time (TBUT) [(4- / 12-week-point)]

      The time taken from the last blink to the appearance of a black spot on the cornea after fluorescein dye staining. (second, numerical)

    6. Limbal and bulbar hyperemia [(4- / 12-week-point)]

      The conjunctival hyperemia was assessed using Efron grading scales (0 to 4, the higher the worse)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • IOP >/= 15mmHg and < 40 mmHg in each eye using Goldmann applanation tonometry at visit 2

    • Written consent voluntarily to participate in this clinical trial

    Exclusion Criteria:

    • Patients with closed-angle, congenital glaucoma or secondary glaucoma caused by steroid drugs, etc.

    • best-corrected visual acuity 20/80 or less

    • Patients who have ongoing medical history of ocular inflammation

    • central corneal thickness is not in between 470um and 591um.

    • Patients who have received lacrimal duct procedure within the last 3 months or who have plans to have it.

    • pregnant or nursing women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHA University Bundang Medical Center Seongnam Bundang-gu Korea, Republic of 13497

    Sponsors and Collaborators

    • CHA University
    • Samil Pharmaceutical Co., Ltd.

    Investigators

    • Principal Investigator: Seungsoo Rho, MD, PhD, CHA Bundang Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CHA University
    ClinicalTrials.gov Identifier:
    NCT04743622
    Other Study ID Numbers:
    • MIT 2019-02-020
    First Posted:
    Feb 8, 2021
    Last Update Posted:
    Feb 8, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Glaucoma
    Ocular Hypertension
    Latanoprost

    Study Results

    No Results Posted as of Feb 8, 2021