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Keratitis, HerpeticOHSVNCT03013959

Observation on the Herpes Simplex Keratitis

An observational study of Keratitis, Herpetic, run by Peking Union Medical College at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

As is reported, NSAIDs(pranoprofen ,bromfenac) eye drops can suppress herpes simplex virus(HSV-1) reactivation and reduce inflammatory reaction in vitro and in vivo. In Clinical, there is no risk of corneal tissue melting, glaucoma, cataract by topical application of NSAIDs. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Keratitis, Herpetic
What is being tested?
Pranoprofen
How many people
100 participants
Where
1 siteChina
Study dates
Nov 2016to Sep 2018
How long will I take part?
12 Months
Phase
Observational
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: 1. Eyes with typical stromal infiltration, typical herpes simplex virus keratitis patients 2. Eyes with a history of recurrent erythema, pain, recurrent disease

Who may be able to join

  • Eyes with typical stromal infiltration, typical herpes simplex virus keratitis patients
  • Eyes with a history of recurrent erythema, pain, recurrent disease

Who cannot join

  • Patients with immune dysfunction or receiving immunosuppressive therapy
  • Patients with cardiac and pulmonary insufficiency
  • Patients with liver function, renal insufficiency
  • Patients with allergic reactions to related drugs
  • Patients with history of corneal surgery
  • Pregnant women and breast-feeding women
  • Patients with diabetes
  • Patients with malignant tumor history

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100000

    Yang Jiang, md, +8613521676533, jiangyangpumch@126.com

    Recruiting

Other trials in China

About this study

Official title: Observation on Effect of Anti--inflammatory and Inhibition of Recurrence on the Herpes Simplex Keratitis After Topical NSAIDs Administration

As is reported, NSAIDs(pranoprofen ,bromfenac) eye drops can suppress herpes simplex virus(HSV-1) reactivation and reduce inflammatory reaction in vitro and in vivo. In Clinical, there is no risk of corneal tissue melting, glaucoma, cataract by topical application of NSAIDs. To explore more effective clinical treatment of viral keratitis patients to control the inflammatory damage, save the visual function and reduce the recurrence of the virus ,we observe the effect of anti-inflammatory and inhibition of recurrence on the herpes simplex virus after topical NSAIDs administration.

Read the detailed description

Viral keratitis has now become the highest incidence and the most severe-caused blindness corneal disease in the worldwide, as is superior to bacterial keratitis and fungal keratitis. At present, clinical treatments mainly depend on local and systematic use of antiviral drugs for viral keratitis, which can inhibit replication of viruses in corneal tissues and directly damage viral action. However, basal studies for viral keratitis have suggested that pathological immune injury produced by the body also play an important role in the formation of corneal ulcer, the damage of visual function in patients, during the necrotic stromal inflammation phase, endotheliitis phase and even serious combination of iridocyclitis phase of viral keratitis. There is, however, a larger controversy in the hormone therapy for this disease clearly caused by pathological immune injury in medical world. Patients with infectious keratitis caused by viral infection, who receive hormone treatment, may cause viral replication enhanced and out of control, and hormone itself could also cause spontaneous corneal tissues fusion; hence, treatments combined with hormone have a certain risks. In clinical treatments, permanent corneal opacity caused by corneal inflammation responses will cause patients permanent visual acuity loss, after patients' corneal lesions were controlled with simple use of antiviral drugs. Another important reason is the high incidence of blindness caused by viral keratitis: herpesvirus, such as herpes simplex virus and herpes zoster virus, will involve trigeminal ganglia and hide after primary infection, and will repeatedly recur under the stimulation of excessive drinking, menstruation, taking a cold and operation etc.. Viral keratitis often does not cause patients severe visual impairment at initial onset. But, viruses in patients with herpes simplex virus keratitis show extremely high recurrence rates. As suggested in epidemiologic studies in the Euro-American countries, its recurrence rate could be up to 30% in the first year, and 46% in the second years. In most cases, transparent corneal tissues develop nephelium and even macular nebula opacities after repeated recurring, and patients eventually lose visual acuity, becoming people with blindness and disabilities. Nonsteroidal antiinflammatory drugs, such as pranoprofen and bromfenac sodium, show significant inhibition of virus recurrence and relief of corneal inflammation responses in experiments in vitro and animal experiments, which indicated in previous studies. In clinical, local application of nonsteroidal antiinflammatory drugs does not result in spontaneous corneal tissue fusion, drug-induced glaucoma, drug-induced cataract and other risks. In order to seek more effective clinical treatments for viral keratitis patients in terms of controlling inflammation injury, preserving visual functions and reducing virus recurrence, this study observed that pranoprofen, a nonsteroidal antiinflammatory drug, inhibits pathological immune injury of viral keratitis and prevents this disease recurring, according to the basal research background of viral keratitis.

Being tested
Pranoprofen
Medical subject headings
Keratitis, Herpetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PranoprofenDrug

    Also called Pranopulin

    it is an NSAIDs.As is reported, NSAIDs(pranoprofen) eye drops can suppress herpes simplex virus(HSV-1) reactivation and reduce inflammatory reaction in vitro and in vivo. In Clinical, there is no risk of corneal tissue melting, glaucoma, cataract by topical application of NSAIDs.

Study groups in NCT03013959
Study groupRoleWhat they receive
Resting control groupThe rest group is to study the effect of the inhibition of recurrence . Patients with redness, pain, decreased visual acuity and other reaction activity in the past 30 days are observed as control group
Resting test groupThe rest group is to study the effect of the inhibition of recurrence . Patients with redness, pain, decreased visual acuity and other reaction activity in the past 30 days are treated with pranoprofen and observed as test group
Receives: Drug: Pranoprofen
Active control groupThe active control group is to study the effect of anti--inflammatory. Patients with a new redness, pain, decreased visual acuity and other reaction activity recently are observed as control group
Active test groupThe active test group is to study the effect of anti--inflammatory. Patients with a new redness, pain, decreased visual acuity and other reaction activity recently are treated with pranoprofen and observed as test group
Receives: Drug: Pranoprofen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. inhibition of recurrence on the herpes simplex virus

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2017 (estimated)
  2. Study startNov 2016
  3. Primary completionMar 2018 (estimated)
  4. Study completionSep 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Enrolment
100 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03013959
Sponsor's protocol ID
PekingUMC
Acronym
OHSV
Status last verified
Jan 2017
First submitted
5 Jan 2017
Last updated
9 Jan 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Keratitis, Herpetic, run by Peking Union Medical College at 1 site in China.

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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yang Jiang, md (+8613521676533, jiangyangpumch@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

inhibition of recurrence on the herpes simplex virus (time frame: 12 months). 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 9 Jan 2017; AzTrials last refreshed its copy on 28 Oct 2026.

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