NCT02136589

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2011

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
Last Updated

May 13, 2014

Status Verified

May 1, 2014

Enrollment Period

3 months

First QC Date

July 20, 2011

Last Update Submit

May 12, 2014

Conditions

HyperemiaIntraocular Pressure

Outcome Measures

Primary Outcomes (1)

  • IOP reduction

    effect of NSAID on IOP reduction by travoprost

    1 day

Study Arms (1)

Dicrofenac

EXPERIMENTAL
Drug: dicrofenac and travoprost

Interventions

dicrofenac and travoprostDRUG

dicrofenac drop 3 times a day travoprost 0.005% once daily

Dicrofenac

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyperemia

Interventions

DiclofenacTravoprost

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 20, 2011

First Posted

May 13, 2014

Study Start

September 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

May 13, 2014

Record last verified: 2014-05