A Phase 3 interventional study of Chloroprocaine 3% and Tetracaine 0.5% in Cataract, sponsored by Sintetica SA. Completed at 27 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by Sintetica SA · Phase 3, Interventional, and Treatment
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.
Prospective,randomized, multi-center, active-controlled, masked-observer, parallel-group, competitive equivalence study. The study has been designed to assess the equivalence of chloroprocaine 3% gel (Test) with respect to tetracaine 0.5% solution (Reference) in surface anesthesia. Patients in both groups will receive three drops of study products before surgery. The study will include a Selection visit (Day -90/Day -1), an Inclusion visit (Day 1/surgery day), a Follow-up visit (Day 2, phone visit), a Final visit (Day 8), and a Follow-up phone call - Optional (Day 28, phone visit).
Selection visit (Visit 1, Day -90/Day -1):
Patients scheduled to undergo cataract surgery in a single eye will be informed about the aims, procedures and possible risks of the study and will be asked to sign the informed consent form for the inclusion in the trial.
Inclusion visit/Surgery (Visit 2, Day 1):
Before the anesthesia, patients will be questioned about previous and concomitant ocular and non-ocular treatments. Inclusion /exclusion criteria and patient status will be verified. Patients will be randomized to either chloroprocaine 3% gel (Test) or tetracaine 0.5% eye drop (Reference) treatment group.
Follow-up visit/phone visit (Visit 3, Day 2):
Concomitant ocular and non-ocular treatments, AEs, and patient global satisfaction will be assessed.
Final visit (Visit 4, Day 8 ± 1 day):
Concomitant ocular and non-ocular treatments, ocular symptoms, best far corrected visual acuity in both eyes, endothelial cell count, corneal thickness, blood pressure and heart rate, and AEs will be assessed. Slit lamp examination and fluorescein test, IOP in both eyes, and fundoscopy will be performed.
Optional visit/phone visit (Visit 5, Day 28 ± 3 days):
Concomitant ocular and non-ocular treatments and AEs resolution will be assessed.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 338 is above the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Sintetica SA is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria.
Drug: Chloroprocaine 3%
All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria.
Drug: Tetracaine 0.5%
Administration: three IMP drops instillation as follow: * 1st Drop instillation, then wait for 5 minutes * Eye Disinfection, then wait for 2 minutes * 2nd Drop instillation, then wait for 1 minute * 3rdDrop instillation, then wait for 1 minute * Start of Surgery.
Also known as: Arm 1
Administration: three IMP drops instillation as follow: * 1st Drop instillation, then wait for 5 minutes * Eye Disinfection, then wait for 2 minutes * 2nd Drop instillation, then wait for 1 minute * 3rdDrop instillation, then wait for 1 minute * Start of Surgery.
Also known as: Arm 2
Number of Participants in Each Treatment Group With a Successful Surface Anesthesia
Τhe primary endpoint is the number of partecipants in each treatment group with a successful surface anesthesia, without any supplementation at the time point T4 (1 minute after the 3rd drop installation)
Time frame: Before Intra Ocular Lens (IOL) implantation surgery.
Changes in Ocular Symptoms
Changes in ocular symptoms (pain, irritation/burning/stinging, foreign body sensation) will be graded by the patients according to the following scale (0 is the minimum value and 3 is tha maximum value) (0 = absent, 1 = mild, 2 = moderate, 3 = severe) during the study on Visit 1-selection and on visit 4-final
Time frame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Objective Ocular Signs
- Objective ocular signs assessed by slit lamp examination, flare, and other objective ocular signs will be graded according to the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. The minimum value is 0 and maximum value is 3
Time frame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Fluoresceine
Modification of the basal status evaluated with fluorescein test Approximately 2-3 minutes following fluorescein instillation, corneal staining was to be evaluated in both eyes, using a slit lamp, based on the Oxford scale (grades of 0-5: 0 is normal, 5 is severe abnormal).
Time frame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Endothelial Cell Counts
Modification of the basal status of the Endothelial cell counts evaluated with the specular microscopy
Time frame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Corneal Thickness
Modification of the basal status of the assesment (Corneal thickness). Measurement of the central corneal thickness was to be performed with a pachymeter
Time frame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Best Far Corrected Visual Acuity
Modification of the basal status of the assesment evaluated by LogMAR (Logarithm of the Minimum Angle of Resolution). When using a LogMAR chart, visual acuity is scored with reference to the logarithm of the minimum angle of resolution, as the chart's name suggests. An observer who can resolve details as small as 1 minute of visual angle scores LogMAR 0, since the base-10 logarithm of 1 is 0; an observer who can resolve details as small as 2 minutes of visual angle (i.e., reduced acuity) scores LogMAR 0.3, since the base-10 logarithm of 2 is near-approximately 0.3; and so on.
Time frame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Number of Participants With Abnormalities of the Retina, Macula, or Optic Nerve by Fundoscopy
Modification of the basal status of the assesment. Dilated fundus examination on retina, macula, optic nerve.
Time frame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Intra-ocular Pressure
Modification of the basal status of the assesment. Intraocular pressure (in mmHg) was assessed according to site current practice (air puff or applanation tonometer).
Time frame: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days
Surgeon Satisfaction
Evaluation of surgeon satisfaction. Surgeon satisfaction was assessed through the question "How do you consider the study product global tolerance?", at a scale (a score of 0 is the minimum value with the best outcome and 3 is the maximum value with the worst outcome): (0) Very satisfactory, (1) Satisfactory, (2) Not very satisfactory, (3) Unsatisfactory. It is recorded at V2 and filled in by the surgeon who had performed the study. It is measured at Visit 2.
Time frame: day 1 - visit2 (Inclusion visit/Surgery)
Patient Global Satisfaction
Patient global satisfaction at D1 based on a 5-question questionnaire read by a masked observer. A question read by a masked observer assessed the patient satisfaction about the overall anesthesia during the surgery: "Overall, how satisfied are you with the topical study product used for your local anesthesia during your cataract surgery?" It was measured with 5 possible answers (Likert satisfaction scale): Very satisfied (0), Globally satisfied (1), Neither satisfied nor Unsatisfied (2), Globally unsatisfied (3), Very unsatisfied (4). It was measured at Visit 3.
Time frame: day 1 - visit2 (Inclusion visit/Surgery) after the treatment
In total, 410 subjects were screened in the study, 64 of which were dropped as screen failure and 346 were randomised to receive a treatment. From the 346 subjects randomised, 338 were treated and received the drug that was assigned at the randomization procedure, while 8 discontinued before treatment. Eventually, 335 subjects completed the study since discontinuation issues occurred for three subjects, one due to an AE and two lost to follow-up
| Milestone | Chloroprocaine 3% | Tetracaine 0.5% |
|---|---|---|
| Started | 167 | 171 |
| Completed | 167 | 168 |
| Not completed | 0 | 3 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 2 |
Τhe primary endpoint is the number of partecipants in each treatment group with a successful surface anesthesia, without any supplementation at the time point T4 (1 minute after the 3rd drop installation)
| participants | Chloroprocaine 3% | Tetracaine 0.5% |
|---|---|---|
| Anesthesia Success | 153 | 152 |
| Anesthesia NO Success | 14 | 19 |
Changes in ocular symptoms (pain, irritation/burning/stinging, foreign body sensation) will be graded by the patients according to the following scale (0 is the minimum value and 3 is tha maximum value) (0 = absent, 1 = mild, 2 = moderate, 3 = severe) during the study on Visit 1-selection and on visit 4-final
| score on a scale | Chloroprocaine 3% | Tetracaine 0.5% |
|---|---|---|
| Foreign Body Sensation visit1 | 0.08 ± 0.32 | 0.06 ± 0.33 |
| Foreign Body Sensation visit4 | 0.19 ± 0.43 | 0.17 ± 0.41 |
| Irritation/Burning/Stinging visit1 | 0.11 ± 0.33 | 0.11 ± 0.37 |
| Irritation/Burning/Stinging visit4 | 0.11 ± 0.36 | 0.15 ± 0.39 |
| pain visit1 | 0.01 ± 0.11 | 0.01 ± 0.08 |
| pain visit4 | 0.05 ± 0.24 | 0.05 ± 0.24 |
- Objective ocular signs assessed by slit lamp examination, flare, and other objective ocular signs will be graded according to the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. The minimum value is 0 and maximum value is 3
| score on a scale | Chloroprocaine 3% | Tetracaine 0.5% |
|---|---|---|
| Anterior Chamber Cells and Flare visit1 | 0 ± 0 | 0 ± 0 |
| Anterior Chamber Cells and Flare visit4 | 0.04 ± 0.24 | 0.03 ± 0.2 |
| Chemosis visit1 | 0.03 ± 0.17 | 0.04 ± 0.23 |
| Chemosis visit4 | 0.09 ± 0.33 | 0.09 ± 0.33 |
Modification of the basal status evaluated with fluorescein test Approximately 2-3 minutes following fluorescein instillation, corneal staining was to be evaluated in both eyes, using a slit lamp, based on the Oxford scale (grades of 0-5: 0 is normal, 5 is severe abnormal).
| score on a scale | Chloroprocaine 3% | Tetracaine 0.5% |
|---|---|---|
| Corneal Fluorescein Staining visit1 | 0.21 ± 0.61 | 0.16 ± 0.52 |
| Corneal Fluorescein Staining visit4 | 0.32 ± 0.68 | 0.25 ± 0.66 |
Modification of the basal status of the Endothelial cell counts evaluated with the specular microscopy
| cell/mm^2 | Chloroprocaine 3% | Tetracaine 0.5% |
|---|---|---|
| Endothelial Cells Count [cell/mm2] visit1 | 2440.76 ± 378 | 2511.89 ± 325.32 |
| Endothelial Cells Count [cell/mm2] visit4 | 2049.88 ± 620.43 | 2166.96 ± 517.41 |
Modification of the basal status of the assesment (Corneal thickness). Measurement of the central corneal thickness was to be performed with a pachymeter
| um | Chloroprocaine 3% | Tetracaine 0.5% |
|---|---|---|
| visit 1 (Day -90/Day -1) | 539.59 ± 39.3 | 536.59 ± 37.16 |
| visit 4 (Day 8 ± 1 day) | 557.8 ± 48.8 | 546.54 ± 42.15 |
Modification of the basal status of the assesment evaluated by LogMAR (Logarithm of the Minimum Angle of Resolution). When using a LogMAR chart, visual acuity is scored with reference to the logarithm of the minimum angle of resolution, as the chart's name suggests. An observer who can resolve details as small as 1 minute of visual angle scores LogMAR 0, since the base-10 logarithm of 1 is 0; an observer who can resolve details as small as 2 minutes of visual angle (i.e., reduced acuity) scores LogMAR 0.3, since the base-10 logarithm of 2 is near-approximately 0.3; and so on.
| LogMAR | Chloroprocaine 3% | Tetracaine 0.5% |
|---|---|---|
| Best Corrected Visual Acuity LogMAR visit1 | 0.49 ± 0.31 | 0.47 ± 0.32 |
| Best Corrected Visual Acuity LogMAR visit4 | 0.12 ± 0.19 | 0.08 ± 0.15 |
Modification of the basal status of the assesment. Dilated fundus examination on retina, macula, optic nerve.
| Participants | Chloroprocaine 3% | Tetracaine 0.5% |
|---|---|---|
| macula abnormal V1 | 15 | 16 |
| macula abnormal V4 | 13 | 10 |
| optic nerve abnormal V1 | 16 | 16 |
| optic nerve abnormal V4 | 12 | 10 |
| retina abnormal V1 | 13 | 11 |
| retina abnormal V4 | 13 | 12 |
Modification of the basal status of the assesment. Intraocular pressure (in mmHg) was assessed according to site current practice (air puff or applanation tonometer).
| mmHg | Chloroprocaine 3% | Tetracaine 0.5% |
|---|---|---|
| visit 1 Selection | 15 ± 2.69 | 15 ± 2.46 |
| visit 4 Final | 14.7 ± 2.8 | 14.88 ± 3.05 |
Evaluation of surgeon satisfaction. Surgeon satisfaction was assessed through the question "How do you consider the study product global tolerance?", at a scale (a score of 0 is the minimum value with the best outcome and 3 is the maximum value with the worst outcome): (0) Very satisfactory, (1) Satisfactory, (2) Not very satisfactory, (3) Unsatisfactory. It is recorded at V2 and filled in by the surgeon who had performed the study. It is measured at Visit 2.
| score on a scale | Chloroprocaine 3% | Tetracaine 0.5% |
|---|---|---|
| Surgeon Satisfaction | 0.17 ± 0.41 | 0.17 ± 0.47 |
Patient global satisfaction at D1 based on a 5-question questionnaire read by a masked observer. A question read by a masked observer assessed the patient satisfaction about the overall anesthesia during the surgery: "Overall, how satisfied are you with the topical study product used for your local anesthesia during your cataract surgery?" It was measured with 5 possible answers (Likert satisfaction scale): Very satisfied (0), Globally satisfied (1), Neither satisfied nor Unsatisfied (2), Globally unsatisfied (3), Very unsatisfied (4). It was measured at Visit 3.
| score on a scale | Chloroprocaine 3% | Tetracaine 0.5% |
|---|---|---|
| Patient Global Satisfaction | 1.35 ± 0.66 | 1.27 ± 0.52 |
Collected over Adverse events were to be monitored throughout the course of the study Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day)) up to "Visit 5 (Day 28 ± 3 days; approximately 129 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chloroprocaine 3% | 0/167 (0%) | 0/167 (0%) | 14/167 (8.4%) |
| Tetracaine 0.5% | 0/171 (0%) | 0/171 (0%) | 19/171 (11.1%) |
| Event | Chloroprocaine 3% | Tetracaine 0.5% |
|---|---|---|
| corneal edemaEye disorders | 5/167 | 2/171 |
| blood pressure increasedInvestigations | 0/167 | 3/171 |
| Intraocular pressure increasedInvestigations | 1/167 | 3/171 |
| general disorderEye disorders | 2/167 | 0/171 |
| Conjunctival hemorrhageEye disorders | 1/167 | 0/171 |
| hyperesthesiaEye disorders | 1/167 | 0/171 |
| photophobiaEye disorders | 1/167 | 1/171 |
| keratitisEye disorders | 1/167 | 1/171 |
| Retinal pigment epitheliopathyEye disorders | 1/167 | 0/171 |
| pyrexiaEye disorders | 1/167 | 0/171 |
| Age, Continuous(years) | Chloroprocaine 3% | Tetracaine 0.5% | Total |
|---|---|---|---|
| Mean | 70.3 ± 10.3 | 68.8 ± 9.9 | 69.9 ± 10.1 |
| Sex: Female, Male(Participants) | Chloroprocaine 3% | Tetracaine 0.5% | Total |
|---|---|---|---|
| Female | 94 | 86 | 180 |
| Male | 73 | 85 | 158 |
| Race and Ethnicity Not Collected(Participants) | Chloroprocaine 3% | Tetracaine 0.5% | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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