HyperemiaPhase 4ENTICHIRNCT02136589
Effect of NSAID on Travoprost-induced Conjunctival Hyperemia and IOP Reduction in Normal Eyes
A Phase 4 study testing dicrofenac and travoprost in people with Hyperemia and Intraocular Pressure, run by Tokyo University.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperemia, Intraocular Pressure
- What is being tested?
- dicrofenac and travoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Dec 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal healthy eye
- not applicable for IOP level
- not wearing contact lenses
- not applicable for the presence of the ocular surface diseases in case the treatment was not needed
Who cannot join
- the eyes with chronic or recurrent uveitis, scleritis, corneal herpes infection
- the eyes with the history of trauma, intraocular surgery, or Laser surgery within 6 months
- the eyes with difficulty for the measurement of IOP with the applanation tonometer
- the subjects with the allergy for PG-analogues or benzalkonium chloride
- the subjects using the eyedrops excluding those in this study
- the subjects treated with oral carbonic anhydrase inhibitor
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- the subject with Sjogren syndrome
- the subjects who can not drop periodically
- the subjects with the advanced glaucoma or the terminal stage of glaucoma
- the subjects with the severe ocular complications
About this study
Official title: 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.
- Conditions
- Hyperemia, Intraocular Pressure
- Being tested
- dicrofenac and travoprost
- Medical subject headings
- Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dicrofenac and travoprostDrug
dicrofenac drop 3 times a day travoprost 0.005% once daily
| Study group | Role | What they receive |
|---|---|---|
| Dicrofenac | Experimental | Not described Receives: Drug: dicrofenac and travoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP reduction
effect of NSAID on IOP reduction by travoprost
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startSep 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokyo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makoto Aihara, Tokyo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136589
- Sponsor's protocol ID
- CS-097
- Acronym
- ENTICHIR
- Status last verified
- May 2014
- First submitted
- 20 Jul 2011
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-steroid Anti-inflammatory Drug on Travoprost-induced Conjunctival Hyperemia and Intraocular Pressure Reduction in Normal Eyes
- ClinicalTrials.gov ID
- NCT02136589
- Acronym / sponsor ID
- ENTICHIR / CS-097
- Conditions
- Hyperemia, Intraocular Pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tokyo UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 13 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dicrofenac | Experimental | Drug: dicrofenac and travoprost |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- normal healthy eye
- not applicable for IOP level
- not wearing contact lenses
- not applicable for the presence of the ocular surface diseases in case the treatment was not needed
Key exclusion criteria (10 listed)
- the eyes with chronic or recurrent uveitis, scleritis, corneal herpes infection
- the eyes with the history of trauma, intraocular surgery, or Laser surgery within 6 months
- the eyes with difficulty for the measurement of IOP with the applanation tonometer
- the subjects with the allergy for PG-analogues or benzalkonium chloride
- the subjects using the eyedrops excluding those in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dicrofenac and travoprostdicrofenac drop 3 times a day travoprost 0.005% once daily | Drug | Dicrofenac |
Primary outcome
IOP reduction
Time frame: 1 day
effect of NSAID on IOP reduction by travoprost
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dicrofenac and travoprost in people with Hyperemia and Intraocular Pressure, run by Tokyo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP reduction (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2014.