Effect of NSAID on Travoprost-induced Conjunctival Hypere... | NCT02136589

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

NCT02136589

Sponsor

Tokyo University

Status

Completed

Last Update Posted

May 13, 2014Estimated

Enrollment

40Actual

Phase

Phase 4

Conditions

Hyperemia
Intraocular Pressure

Interventions

dicrofenac and travoprost

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jul 20, 2011

First Submission Date that Met QC Criteria

May 12, 2014

First Posted Date

May 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2014

Last Update Posted Date

May 13, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dicrofenac	Experimental		Drug: dicrofenac and travoprost

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dicrofenac and travoprost	Drug	dicrofenac drop 3 times a day travoprost 0.005% once daily	Dicrofenac

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IOP reduction	effect of NSAID on IOP reduction by travoprost	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006940	Hyperemia

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004008	Diclofenac
D000069557	Travoprost

Ancestor Terms

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided