Phase 3
N=338
Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT04685538 ↗Enrolled (actual)
338
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Number of Participants in Each Treatment Group With a Successful Surface Anesthesia — 153; 152; 14; 19 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Chloroprocaine 3% (Drug); Tetracaine 0.5% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sintetica SA
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants in Each Treatment Group With a Successful Surface Anesthesia |
153; 152; 14; 19 | — |
| SECONDARY Changes in Ocular Symptoms |
0.08; 0.06; 0.19; 0.17; 0.11; 0.11 | — |
| SECONDARY Objective Ocular Signs |
0; 0; 0.04; 0.03; 0.03; 0.04 | — |
| SECONDARY Fluoresceine |
0.21; 0.16; 0.32; 0.25 | — |
| SECONDARY Endothelial Cell Counts |
2440.76; 2511.89; 2049.88; 2166.96 | — |
| SECONDARY Corneal Thickness |
539.59; 536.59; 557.8; 546.54 | — |
| SECONDARY Best Far Corrected Visual Acuity |
0.49; 0.47; 0.12; 0.08 | — |
| SECONDARY Number of Participants With Abnormalities of the Retina, Macula, or Optic Nerve by Fundoscopy |
15; 16; 13; 10; 16; 16 | — |
| SECONDARY Intra-ocular Pressure |
15; 15; 14.7; 14.88 | — |
| SECONDARY Surgeon Satisfaction |
0.17; 0.17 | — |
| SECONDARY Patient Global Satisfaction |
1.35; 1.27 | — |
Summary
Randomized clinical trial, multicenter, two-armed, to investigate and compare the clinical efficacy of chloroprocaine 3% gel and tetracaine 0.5% eye drop as topical anestheticsin phacoemulsification. This prospective, observer masked, randomised, controlled, equivalence phase 3 study will be conducted in approximately 4 European Countries. Sintetica intends to perform a phase 3 study on patients undergoing cataract surgery to assess the safety and efficacy of topical anaesthesia using chloroprocaine gel.
Eligibility Criteria
Inclusion Criteria
- Signed and dated informed consent
- Male or female aged≥ 18 years
- Senile or pre-senile cataract
- Scheduled to undergo cataract surgery in a single eyeat a time (clear corneal self-sealing incisions - phacoemulsification - foldable intra-ocular lens surgery with injector)
Exclusion Criteria
- Combined surgery
- Previous intraocular surgery
- Previous corneal refractive surgeries less than 6 months before screening
- Non Senile or non pre-senilecataract (e.g.: traumatic, pathological or congenital cataract)
- Pupillary abnormalities (irregular, etc.)
- Iris synechiae
- Eye movement disorder (nystagmus, etc.)
- 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
- Pseudo-exfoliation, exfoliative syndrome
- Prior intravitreal injections within 7 days of the surgery
- IOP over 25mmHg under treatment
- Best corrected visual acuity < 1/10
- Patient already included in the study for phakoexeresis
- History of ophthalmic surgical complication (cystoid macular oedema, etc.)
- Diabetes mellitus
- Surdity
- Pakinsondisease
- Excessive anxiety
- Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplasic, hematological diseases, severe psychiatric illness, relevant cardiovascular abnormalities (such as unstable angina, bradycardia, atrial fibrillation,uncontrolled hypertension: systolic blood pressure over 140 mm Hg, diastolic blood pressure over 90 mmHg) and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study.
- Known hypersensitivity to sulfonamides products or any of the components of the study medications or to test products Specific exclusion criteria for women
- Pregnancy (positive pregnancy test), lactation
- Women of childbearing potential without an acceptable effective method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant) until end of the study participation OR
- Women not hysterectomized, not menopaused nor surgically sterilized. Exclusion criteria related to general conditions
- Inability of patient and/or relatives to understand the study procedures and thus inability to give informed consent
- Non-compliant patient and/or relatives (e.g. not willing to attend the follow-up visits, way of life interfering with compliance)
- Participation in anotherclinicalstudy
- Already included once in this study
- Ward of court
- Patient not covered by the Social Security
Data sourced from ClinicalTrials.gov (NCT04685538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.