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
About this trial
This is an interventional treatment trial for Hyperemia
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
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
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
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