Status:
COMPLETED
Efficacy, Safety and Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers
Lead Sponsor:
Sintetica SA
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
PHASE3
Brief Summary
The study assess efficacy, safety and tolerability of Chloroprocaine 3% ophthalmic gel in healthy volunteers.
Detailed Description
The study is carried out in 2 parts. In part I, safety and tolerability is assessed in three groups (12 subjects per group) for single and multiple instillations (1 drop, 3 drops and 3+3 drops). In ea...
Eligibility Criteria
Inclusion
- Signed and dated informed consent
- Healthy male or female aged from 18 to 90 years
- No clinically significant ocular or systemic disease
- Ability to orally respond to pain
- Ability to follow the visit schedule
Exclusion
- Ophthalmic exclusion criteria
- Eye movement disorder (i.e. Nystagmus)
- Dacryocystitis and all other pathologies of tears drainage system
- History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis)
- Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis)
- History of ocular traumatism, infection or inflammation within the last 3 months
- Best corrected visual acuity \< 1/10
- History of ophthalmic surgical complication (i.e. cystoid macular oedema)
- Systemic/non ophthalmic exclusion criteria
- General history:
- 1 Deafness 8.2 Excessive anxiety
- Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplastic, haematological diseases, severe psychiatric illness, relevant cardiovascular abnormalities (such as unstable angina, uncontrolled hypertension: systolic blood pressure over 200 mm Hg, diastolic blood pressure over 100 mm Hg) and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study
- Allergic history: Known hypersensitivity to one of the components of the study medications or to test products
- Specific non-inclusion criteria for women:
- Pregnancy, lactation
- Women without an effective method of contraception (i.e. oral contraceptive, intra-uterine device, subcutaneous contraceptive implant) OR
- Women not hysterectomised, not menopausal nor surgically sterilized
- Exclusion criteria related to general conditions:
- Inability of subject to understand the study procedures and thus inability to give informed consent
- Non-compliant subject (e.g. not willing to attend the follow-up visits, way of life interfering with compliance)
- Participation in another clinical study
- Already included once in this study
- Ward of court
- Subject not covered by the Social Security
- Exclusion criteria related to previous and concomitant medications (taken within 15 days prior screening visit)
- Use of systemic opioids and opioid drugs
- Topical ocular treatment with anaesthetic action
- Use of systemic analgesic drugs (except paracetamol, which will be allowed after Visit 2)
Key Trial Info
Start Date :
June 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2020
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04753710
Start Date
June 29 2020
End Date
December 9 2020
Last Update
March 17 2022
Active Locations (1)
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1
Department of Clinical Pharmacology
Vienna, Austria, 1090