search
Back to results

Effect of NSAID on Travoprost-induced Conjunctival Hyperemia and IOP Reduction in Normal Eyes (ENTICHIR)

Primary Purpose

Hyperemia, Intraocular Pressure

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
dicrofenac and travoprost
Sponsored by
Tokyo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperemia

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. normal healthy eye
  2. not applicable for IOP level
  3. not wearing contact lenses
  4. not applicable for the presence of the ocular surface diseases in case the treatment was not needed

Exclusion Criteria:

  1. the eyes with chronic or recurrent uveitis, scleritis, corneal herpes infection
  2. the eyes with the history of trauma, intraocular surgery, or Laser surgery within 6 months
  3. the eyes with difficulty for the measurement of IOP with the applanation tonometer
  4. the subjects with the allergy for PG-analogues or benzalkonium chloride
  5. the subjects using the eyedrops excluding those in this study
  6. the subjects treated with oral carbonic anhydrase inhibitor
  7. the subject with Sjogren syndrome
  8. the subjects who can not drop periodically
  9. the subjects with the advanced glaucoma or the terminal stage of glaucoma
  10. the subjects with the severe ocular complications

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Dicrofenac

    Arm Description

    Outcomes

    Primary Outcome Measures

    IOP reduction
    effect of NSAID on IOP reduction by travoprost

    Secondary Outcome Measures

    Full Information

    First Posted
    July 20, 2011
    Last Updated
    May 12, 2014
    Sponsor
    Tokyo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02136589
    Brief Title
    Effect of NSAID on Travoprost-induced Conjunctival Hyperemia and IOP Reduction in Normal Eyes
    Acronym
    ENTICHIR
    Official Title
    Effect of Non-steroid Anti-inflammatory Drug on Travoprost-induced Conjunctival Hyperemia and Intraocular Pressure Reduction in Normal Eyes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2008 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tokyo University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    PG-analogues induce hyperemia as one of side effects in addition to IOP reduction. IOP reduction is caused by direct FP receptor stimulation, but the cause of hyperemia is not clarified. Because FP receptor stimulation induce intrinsic production of PGs, hyperemia or IOP reduction may be due to secondary induced PGs. Thus, pretreatment with NSAID may affect the PG-analogue induced hyperemia or IOP reduction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperemia, Intraocular Pressure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dicrofenac
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    dicrofenac and travoprost
    Intervention Description
    dicrofenac drop 3 times a day travoprost 0.005% once daily
    Primary Outcome Measure Information:
    Title
    IOP reduction
    Description
    effect of NSAID on IOP reduction by travoprost
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: normal healthy eye not applicable for IOP level not wearing contact lenses not applicable for the presence of the ocular surface diseases in case the treatment was not needed Exclusion Criteria: the eyes with chronic or recurrent uveitis, scleritis, corneal herpes infection the eyes with the history of trauma, intraocular surgery, or Laser surgery within 6 months the eyes with difficulty for the measurement of IOP with the applanation tonometer the subjects with the allergy for PG-analogues or benzalkonium chloride the subjects using the eyedrops excluding those in this study the subjects treated with oral carbonic anhydrase inhibitor the subject with Sjogren syndrome the subjects who can not drop periodically the subjects with the advanced glaucoma or the terminal stage of glaucoma the subjects with the severe ocular complications

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of NSAID on Travoprost-induced Conjunctival Hyperemia and IOP Reduction in Normal Eyes

    We'll reach out to this number within 24 hrs