2023-504477-21-00
Withdrawn
Phase 3
A prospective, observer-blind, randomized clinical trial to investigate and compare the clinical efficacy of Chloroprocaine 3% gel and Oxybuprocaine 0.4% eye drops anesthesia for clinical practice in pediatric population.
Overview
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Sintetica S.A.
- Enrollment
- 74
- Locations
- 3
- Primary Endpoint
- Primary endpoint will be to assess the proportion of patients in each treatment group with a successful conjunctiva anesthesia in the right eye, 5 minutes after study product administration, i.e. right before the ocular examination, to be assessed by eye spear sponge.
Overview
Brief Summary
The primary objective of the study is to evaluate the efficacy of Chloroprocaine 3% ophthalmic gel as compared to Oxybuprocaine chlorhydrate 0.4% eye drops anesthesia for clinical practice in pediatric population
Study Design
- Allocation
- Randomized
- Primary Purpose
- A Prospective, Observer-blind, Randomized Clinical Trial To Investigate And Compare The Clinical...
- Masking
- Single (Investigator, Subject)
Eligibility Criteria
- Ages
- 0 years to 17 years (0-17 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •To be enrolled in this study, patients must fulfil all these inclusion criteria:
- •Age ≥ one day of life (newborn, infant, child) and 17 years included (not anticipated to turn 18 during the study).
- •Female subjects currently either of: • Non-childbearing potential (i.e., premenarchal or physiologically incapable of becoming pregnant, including any female who is surgically sterilized via documented hysterectomy or bilateral tubal ligation), or • Childbearing potential (i.e., postmenarchal girls): the subject is eligible to enter and participate in this study if she is not lactating, has a negative pregnancy test and agrees to abstain from intercourses or uses a valid contraceptive method until study completion.
- •Signed written informed consent by both parents or legal representative(s) (unless only one has legal authority). Written informed assent for adolescents aged 12-17 years included and, whenever possible, informed assent for children aged 6 to 11 years included. Ability of the subjects and their parents/legal representative(s) to understand and comply with the protocol requirements, study-specified visit schedule and procedures
- •Scheduled to undergo a routine clinical procedure which needs local ocular surface anesthesia, including but not limited to applanation tonometry, gonioscopy, Ultrasound Biomicroscopy (UBM), ocular ultrasonography, retinal peripheral examination with blepharostat and scleral indentation.
Exclusion Criteria
- •Patients fulfilling at the inclusion visit ONE OR MORE of the following exclusion criteria will not be enrolled in the study: Ophthalmic exclusion criteria
- •Previous ocular surgery less than 6 months before screening
- •Eye movement disorder (nystagmus)
- •History of 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
- •Systemic/non ophthalmic exclusion criteria • General history:
- •Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplasia, hematological diseases, severe psychiatric illness, cardiac rhythm disorders 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 investigational products
- •Exclusion criteria related to general conditions
Outcomes
Primary Outcomes
Primary endpoint will be to assess the proportion of patients in each treatment group with a successful conjunctiva anesthesia in the right eye, 5 minutes after study product administration, i.e. right before the ocular examination, to be assessed by eye spear sponge.
Primary endpoint will be to assess the proportion of patients in each treatment group with a successful conjunctiva anesthesia in the right eye, 5 minutes after study product administration, i.e. right before the ocular examination, to be assessed by eye spear sponge.
Secondary Outcomes
- Safety endpoints: - Objective ocular signs (palpebral edema, chemosis, conjunctival hyperemia, conjunctival discharge, follico-papillary conjunctivitis, corneal staining punctuations, anterior chamber cells, flare) and other objective ocular signs, assessed by slit lamp examination (SLE) or binocular indirect ophthalmoscopy (BIO), will be graded according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe.
- Safety endpoint: Adverse events occurrence throughout the study
- Safety endpoints: Product global tolerance will be graded by the Investigator by answering the following question “How do you consider the study product global tolerance” using the following scale: 0=very unsatisfactory, 1=unsatisfactory, 2= satisfactory, 3=very satisfactory.
Investigators
Sergio Cantoreggi
Scientific
Sintetica S.A.
Study Sites (3)
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