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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02136589
Recruitment Status : Completed
First Posted : May 13, 2014
Last Update Posted : May 13, 2014
Information provided by (Responsible Party):
Makoto Aihara, Tokyo University

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.

Condition or disease Intervention/treatment Phase
Hyperemia Intraocular Pressure Drug: dicrofenac and travoprost Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Non-steroid Anti-inflammatory Drug on Travoprost-induced Conjunctival Hyperemia and Intraocular Pressure Reduction in Normal Eyes
Study Start Date : September 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Travoprost

Arm Intervention/treatment
Experimental: Dicrofenac Drug: dicrofenac and travoprost
dicrofenac drop 3 times a day travoprost 0.005% once daily

Primary Outcome Measures :
  1. IOP reduction [ Time Frame: 1 day ]
    effect of NSAID on IOP reduction by travoprost

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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Responsible Party: Makoto Aihara, Associate Professor, Tokyo University Identifier: NCT02136589     History of Changes
Other Study ID Numbers: CS-097
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: May 13, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents