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

NCT ID: NCT02136589

Last Updated: 2014-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2008-12-31

Brief Summary

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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

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Conditions

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Hyperemia Intraocular Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dicrofenac

Group Type EXPERIMENTAL

dicrofenac and travoprost

Intervention Type DRUG

dicrofenac drop 3 times a day travoprost 0.005% once daily

Interventions

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dicrofenac and travoprost

dicrofenac drop 3 times a day travoprost 0.005% once daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tokyo University

OTHER

Sponsor Role lead

Responsible Party

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Makoto Aihara

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CS-097

Identifier Type: -

Identifier Source: org_study_id

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