Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Observation on the Herpes Simplex Keratitis (OHSV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03013959
Recruitment Status : Unknown
Verified January 2017 by Yang Jiang, Peking Union Medical College.
Recruitment status was:  Recruiting
First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Yang Jiang, Peking Union Medical College

Brief 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. 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.

Condition or disease Intervention/treatment
Keratitis, Herpetic Drug: Pranoprofen

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case Control
Target Follow-Up Duration: 12 Months
Official Title: Observation on Effect of Anti--inflammatory and Inhibition of Recurrence on the Herpes Simplex Keratitis After Topical NSAIDs Administration
Study Start Date : November 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herpes Simplex

Group/Cohort Intervention/treatment
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
Drug: Pranoprofen
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.
Other Name: Pranopulin

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
Drug: Pranoprofen
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.
Other Name: Pranopulin




Primary Outcome Measures :
  1. inhibition of recurrence on the herpes simplex virus [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with immune dysfunction or receiving immunosuppressive therapy
  2. Patients with cardiac and pulmonary insufficiency
  3. Patients with liver function, renal insufficiency
  4. Patients with allergic reactions to related drugs
  5. Patients with history of corneal surgery
  6. Pregnant women and breast-feeding women
  7. Patients with diabetes
  8. Patients with malignant tumor history

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03013959


Contacts
Layout table for location contacts
Contact: Yang Jiang, md +8613521676533 jiangyangpumch@126.com

Locations
Layout table for location information
China, Beijing
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100000
Contact: Yang Jiang, md    +8613521676533    jiangyangpumch@126.com   
Sponsors and Collaborators
Peking Union Medical College
Investigators
Layout table for investigator information
Study Director: Ying Li, md Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Additional Information:

Layout table for additonal information
Responsible Party: Yang Jiang, Attending Doctor,md, Peking Union Medical College
ClinicalTrials.gov Identifier: NCT03013959    
Other Study ID Numbers: PekingUMC
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Herpes Simplex
Keratitis, Herpetic
Keratitis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Corneal Diseases
Eye Diseases
Eye Infections, Viral
Eye Infections
Pyranoprofen
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Gout Suppressants