Efficacy and safety of GV 550 in acute adenoviral keratoconjunctivitis
- Conditions
- acute adenoviral keratoconjunctivitisMedDRA version: 9.1Level: LLTClassification code 10014975Term: Epidemic keratoconjunctivitis
- Registration Number
- EUCTR2007-002455-16-DE
- Lead Sponsor
- aboratoires Théa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
Written informed consent
Male or female aged from 18 to 80 years old
Acute adenoviral keratoconjunctivitis clinically diagnosed on the basis of:
•First episode
•With an history of unilateral occurrence
•Recent (first symptoms lasting less than 3 days)
•Conjunctival injection
•Tearing
•Without infiltrates
•Without purulent secretion
•With positive rapid test diagnosis (RPS Adeno-detector®)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Active ocular allergy, Ocular herpes disease
•History of bacterial conjunctivitis / blepharoconjunctivitis within the last month before the inclusion visit
•Any relevant ocular anomaly interfering with ocular surface: chemical burns, corneal distrophy, orbital radiotherapy, progressive involvement after traumatism, etc…….
•Best far corrected visual acuity = 1/10
•By questioning: Any known medical or surgical history, disorder or disease such as acute or chronic severe organic disease
•Known hypersensitivity to one of the components of the study products.
•Pregnancy, lactation for women
•Non compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance, man who is not using a local contraceptive method such as condom).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method