healthy volunteers MedDRA version: 20.0 Level: PT Classification code 10024758 Term: Local anaesthesia System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: Chloroprocaine hydrochloride 3% eye gel
Product Code: Chloroprocaine hydrochloride 3% eye gel
Pharmaceutical Form: Eye gel
INN or Proposed INN: Chloroprocaine hydrochloride
CAS Number: 3
Sponsors
Sintetica S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent 2. Healthy male or female aged from 18 to 90 years 3. No clinically significant ocular or systemic disease 4. Ability to orally respond to pain 5. Ability to follow the visit schedule 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 72 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: Ophthalmic exclusion criteria 1. Eye movement disorder (i.e. Nystagmus) 2. Dacryocystitis and all other pathologies of tears drainage system 3. History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis) 4. Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis) 5. History of ocular traumatism, infection or inflammation within the last 3 months 6. Best corrected visual acuity < 1/10 7. Subject already included in the study 8. History of ophthalmic surgical complication (i.e. cystoid macular oedema) Systemic/non ophthalmic exclusion criteria 9. General history: 9.1 Deafness 9.2 Excessive anxiety 10. Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplasic, haematological diseases, severe psychiatric illness, relevant cardiovascular abnormalities (such as unstable angina, uncontrolled hypertension: systolic blood pressure over 200 mmHg, diastolic blood pressure over 100 mmHg) and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study 11. Allergic history: Known hypersensitivity to one of the components of the study medications or to test products Specific non-inclusion criteria for women: 12. Pregnancy, lactation 13. Women without an effective method of contraception (i.e. oral contraceptive, intra-uterine device, subcutaneous contraceptive implant) OR 14. Women not hysterectomised, not menopaused nor surgically sterilized Exclusion criteria related to general conditions: 15. Inability of subject to understand the study procedures and thus inability to give informed consent 16. Non-compliant subject (e.g. not willing to attend the follow-up visits, way of life interfering with compliance) 17. Participation in another clinical study 18. Already included once in this study 19. Ward of court 20. Subject not covered by the Social Security Exclusion criteria related to previous and concomitant medications (taken within 15 days prior screening visit) 21. Use of systemic opioids and morphinic drugs 22. Topical ocular treatment with anaesthetic action 23. Use of systemic analgesic drugs (except paracetamol, which will be allowed after Visit 2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy of Chloroprocaine 3% ophthalmic gel in healthy subjects;Secondary Objective: To assess safety and local tolerability of Chloroprocaine 3% ophthalmic gel;Primary end point(s): Proportion of subjects gaining full anesthesia of the ocular surface 5 minutes after administration of Chloroprocaine 3% ophthalmic gel;Timepoint(s) of evaluation of this end point: 5 minutes after instillation of IMP | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Safety and tolerability as assessed by the occurrence of ocular symptoms, adverse event occurrence and concomitant medication • Time of anesthesia and duration of anesthesia, as well as Cochet Bonnet assessments • Blood pressure and heart rate • Slit lamp examination • Corneal fluorescein staining • Intraocular pressure ;Timepoint(s) of evaluation of this end point: - Visit 2 (Day of administration) - Visit 3 (1 day after administration, phone visit) - Visit 4 (7 +/- 1 days after administration) - Visit 5 (18 +/-3 days after administration, phone visit) | — |
Countries
Austria
Contacts
Public ContactDepartment of Clinical Pharmacology
Medical University of Vienna
Outcome results
None listed