NCT03013959

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

January 5, 2017

Last Update Submit

January 5, 2017

Conditions

Keratitis, Herpetic

Outcome Measures

Primary Outcomes (1)

  • inhibition of recurrence on the herpes simplex virus

    12 months

Study Arms (4)

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

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

Interventions

PranoprofenDRUG

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.

Also known as: Pranopulin
Active test groupResting test group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Keratitis, Herpetic

Interventions

pyranoprofen

Condition Hierarchy (Ancestors)

Eye Infections, ViralEye InfectionsInfectionsHerpes SimplexHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesKeratitisCorneal DiseasesEye Diseases

Study Officials

  • Ying Li, md

    Peking Union Medical College

    STUDY DIRECTOR

Central Study Contacts

Yang Jiang, md

CONTACT

+8613521676533jiangyangpumch@126.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Doctor，md

Study Record Dates

First Submitted

January 5, 2017

First Posted

January 9, 2017

Study Start

November 1, 2016

Primary Completion

March 1, 2018

Study Completion

September 1, 2018

Last Updated

January 9, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

Locations

CN(1)