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

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

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.

Study Overview

• Status: Completed
• Conditions: Intraocular Pressure; Hyperemia
• Intervention / Treatment: Drug: dicrofenac and travoprost

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dicrofenac	Drug: dicrofenac and travoprost; dicrofenac drop 3 times a day travoprost 0.005% once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP reduction	effect of NSAID on IOP reduction by travoprost	1 day

Collaborators and Investigators

• Sponsor: Tokyo University

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: July 20, 2011
• First Submitted That Met QC Criteria: May 12, 2014
• First Posted (Estimate): May 13, 2014

Study Record Updates

• Last Update Posted (Estimate): May 13, 2014
• Last Update Submitted That Met QC Criteria: May 12, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hyperemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac; Travoprost
• Other Study ID Numbers: CS-097