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.
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
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100000
Yang Jiang, md, +8613521676533, jiangyangpumch@126.com
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.
- Conditions
- Keratitis, Herpetic
- 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 group | Role | What they receive |
|---|---|---|
| Resting control group | The 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 group | The 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 group | The 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 group | The 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.
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.
- First posted9 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionMar 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratitis, HerpeticStudies 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
- Observational
- Observational model
- Case-control
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Jiang, Peking Union Medical College
- Investigators
- Ying Li, md, Study director, Peking Union Medical College
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation on Effect of Anti--inflammatory and Inhibition of Recurrence on the Herpes Simplex Keratitis After Topical NSAIDs Administration
- ClinicalTrials.gov ID
- NCT03013959
- Acronym / sponsor ID
- OHSV / PekingUMC
- Conditions
- Keratitis, Herpetic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 9 Jan 2017 (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.
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.
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.
Study design
- Observational model
- Case-control
- Target follow-up
- 12 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Resting control group | – | –The 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 group | – | Drug: PranoprofenThe 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 |
| Active control group | – | –The 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 group | – | Drug: PranoprofenThe 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- Eyes with typical stromal infiltration, typical herpes simplex virus keratitis patients
- Eyes with a history of recurrent erythema, pain, recurrent disease
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| PranoprofenAlso: Pranopulinit 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. | Drug | Active test group, Resting test group |
Primary outcome
inhibition of recurrence on the herpes simplex virus
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Individual participant dataSharing planned: Yes
Related trials for Keratitis, Herpetic
RecruitingPhase 1/2
Clinical Study of Intrastromal Anti-VEGF Injection for Corneal Neovascularization.
Herpes Simplex Keratitis, Corneal Neovascularization
Active, not recruitingPhase 1
A Study of the Safety, Tolerability and Prelinminary Efficacy of BD111 in Herpes Simplex Virus Type I Stromal Keratitis
Herpes Simplex Virus Type I Stromal Keratitis
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.
Ying Li, md study director
Peking Union Medical College
1 site in 1 country: see every site and its status.
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.