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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02136589
Other study ID # CS-097
Secondary ID
Status Completed
Phase Phase 4
First received July 20, 2011
Last updated May 12, 2014
Start date September 2008
Est. completion date December 2008

Study information

Verified date May 2014
Source Tokyo University
Contact n/a
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
dicrofenac and travoprost
dicrofenac drop 3 times a day travoprost 0.005% once daily

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tokyo University

Outcome

Type Measure Description Time frame Safety issue
Primary IOP reduction effect of NSAID on IOP reduction by travoprost 1 day Yes
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