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

T

Tokyo University

Status and phase

Completed
Phase 4

Conditions

Intraocular Pressure
Hyperemia

Treatments

Drug: dicrofenac and travoprost

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

20 to 60 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

40 participants in 1 patient group

Dicrofenac
Experimental group
Treatment:
Drug: dicrofenac and travoprost

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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