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

Intraocular Pressure Clinical Trial

— ENTICHIR  

Official title:

Effect of Non-steroid Anti-inflammatory Drug on Travoprost-induced Conjunctival Hyperemia and Intraocular Pressure Reduction in Normal Eyes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02136589
• Other study ID #: CS-097
• 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

• Endophthalmitis
• Hyperemia
• Intraocular Pressure

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