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The study evaluate the efficacy, safety and local tolerability of Chloroprocaine 3% ophthalmic gel as compared to matching placebo in healthy subjects.
One hundred and five (105) healthy male and female subjects will be randomised in a 4:1 ratio to receive a single ocular instillation of Chloroprocaine 3% ophthalmic gel or matching placebo (vehicle) (84 subjects will receive chloroprocaine and 21 subjects will receive placebo). The assigned investigational product (3 drops) will be instilled in the right eye of each subject. Administrations will be performed at the clinical centre by the Investigator or his deputy on study day 1. For each administration, the 3 drops will be instilled at a 1 min ± 15 sec interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chloroprocaine | Experimental | Chloroprocaine 3% ocular gel (30 mg/mL), 3 drops instilled at a 1 min ± 15 sec interval. |
|
| Placebo | Placebo Comparator | Vehicle for chloroprocaine 3% ocular gel, 3 drops instilled at a 1 min ± 15 sec interval. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocular gel | Drug | 3 drops instilled in the right eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Gaining Full Conjunctival Anesthesia of the Ocular Surface | Number of partecipants gaining full conjunctival anesthesia of the ocular surface, evaluated by conjunctiva pinching (0.3-mm forceps), 5 minutes after administration of Chloroprocaine 3% ophthalmic gel, in comparison to placebo - only study eye (right eye) | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Anesthesia, Evaluated by Conjunctiva Pinching (0.3-mm Forceps) - Only Study Eye (Right Eye) | Time to anesthesia, evaluated by conjunctiva pinching (0.3-mm forceps) - only study eye (right eye) | Day 1 |
| Duration of Anesthesia - Only Right Eye |
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Inclusion Criteria:
Informed consent: Signed written informed consent before inclusion in the study
Sex and age: Healthy men and women, 18 - 55 years inclusive
Body Mass Index: 18.5-30 kg/m2 inclusive
Vital signs: Systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position
Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study
Contraception and fertility: women of child-bearing potential must be using at least one of the following reliable methods of contraception:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Milko Radicioni | CROSS Research S.A., Phase I Clinical Unit, Arzo, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CROSS Research S.A. | Arzo | Switzerland |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chloroprocaine | Chloroprocaine 3% ocular gel (30 mg/mL), 3 drops instilled at a 1 min ± 15 sec interval. Ocular gel: 3 drops instilled in the right eye |
| FG001 | Placebo | Vehicle for chloroprocaine 3% ocular gel, 3 drops instilled at a 1 min ± 15 sec interval. Ocular gel: 3 drops instilled in the right eye |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Phase: Tolerability and Safety |
| |||||||||||||
| Second Phase: Efficacy |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chloroprocaine | Chloroprocaine 3% ocular gel (30 mg/mL), 3 drops instilled at a 1 min ± 15 sec interval. Ocular gel: 3 drops instilled in the right eye |
| BG001 | Placebo | Vehicle for chloroprocaine 3% ocular gel, 3 drops instilled at a 1 min ± 15 sec interval. Ocular gel: 3 drops instilled in the right eye |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Gaining Full Conjunctival Anesthesia of the Ocular Surface | Number of partecipants gaining full conjunctival anesthesia of the ocular surface, evaluated by conjunctiva pinching (0.3-mm forceps), 5 minutes after administration of Chloroprocaine 3% ophthalmic gel, in comparison to placebo - only study eye (right eye) | Posted | Count of Participants | Participants | Day 1 |
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chloroprocaine | Chloroprocaine 3% ocular gel (30 mg/mL), 3 drops instilled at a 1 min ± 15 sec interval. Ocular gel: 3 drops instilled in the right eye |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mydriasis | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Elisabetta Donati, Corporate Director Scientific Affairs | Sintetica SA | +41.91.640.42.50 | edonati@sintetica.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 21, 2020 | Apr 27, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 20, 2020 | Apr 27, 2021 | SAP_001.pdf |
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Duration of anesthesia, evaluated by conjunctiva pinching (0.3-mm forceps) - only study eye (right eye)
| Day 1 |
| Visual Acuity (EDTRS Chart) - Both Eyes | Visual acuity will be assessed, for all subjects and both eyes using an EDTRS chart (visual acuity is scored with reference to the logarithm of the minimum angle of resolution, 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) | Up to day 7 |
| Ocular Symptoms | The ocular symptoms will be assessed: burning, stinging, itching, foreign body sensation. Scores will be determined using a 100 mm VAS where 0 means "no symptoms" and 100 means "worst possible discomfort". | Up to day 7 |
| Ocular Signs by Slit Lamp Examination | Slit lamp biomicroscopy will be performed for the assessment of the following parameters: conjunctival redness, anterior chamber flare, conjunctival chemosis, eyelid swelling. Presence and severity will be graded according to a 4 point scale, where (0) none, (1) mild, (2) moderate, (3) severe. | Up to day 7 |
| Corneal Fluorescein Staining by Slit Lamp Examination - Both Eyes | Fluorescein will be used to detect corneal epithelial defects using slit lamp biomicroscopy. As grading scale for corneal damage, the NEI/Industry Workshop guidelines will be used. The cornea will be divided into five sectors (central, superior, inferior, nasal and temporal), each of which is scored on a scale of 0-3, where 0 means no staining and 3 means maximum staining, with a maximal score of 15. | Up to day 7 |
| Intraocular Pressure (IOP) - Both Eyes | Intraocular pressure will be measured with a slit-lamp mounted Goldmann applanation tonometer. Before each measurement one drop of oxybuprocaine hydrochloride combined with sodium fluorescein will be used for local anaesthesia of the cornea. | Up to day 7 |
| Fundus Ophthalmoscopy (Vitreous, Macula, Retina and Optic Nerve Head) With the Slit Lamp - Both Eyes | Indirect fundus ophthalmoscopy will be performed, for all subjects and both eyes, with the observation at the slit lamp using a +90 diopters Volk lens.The evaluation is performed with a grading scale: 0 None, 1 Mild, 2 Moderate, 3 Severe for each parameters evaluated. | Up to day 7 |
| Vital Signs (Blood Pressure) | Subjects blood pressure will be measured by the Investigator or his/her deputy | Up to day 7 |
| Vital Signs (Heart Rate) | Subjects heart rate will be measured by the Investigator or his/her deputy | Up to day 7 |
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Time to Anesthesia, Evaluated by Conjunctiva Pinching (0.3-mm Forceps) - Only Study Eye (Right Eye) | Time to anesthesia, evaluated by conjunctiva pinching (0.3-mm forceps) - only study eye (right eye) | A total of 105 healthy men and women were planned and enrolled included in the study. Initially, local tolerability and safety was evaluated in the first 20 enrolled subjects . After the first 20 subjects had completed the study, local tolerability and safety data were evaluated and treatment safety was confirmed according to the clinical study protocol specifications. Efficacy, beside local tolerability and safety, was assessed in the 85 subsequent subjects | Posted | Mean | Standard Deviation | minutes | Day 1 |
|
|
|
| Secondary | Duration of Anesthesia - Only Right Eye | Duration of anesthesia, evaluated by conjunctiva pinching (0.3-mm forceps) - only study eye (right eye) | A total of 105 healthy men and women were planned and enrolled included in the study. Initially, local tolerability and safety was evaluated in the first 20 enrolled subjects . After the first 20 subjects had completed the study, local tolerability and safety data were evaluated and treatment safety was confirmed according to the clinical study protocol specifications. Efficacy, beside local tolerability and safety, was assessed in the 85 subsequent subjects | Posted | Mean | Standard Deviation | minutes | Day 1 |
|
|
|
| Secondary | Visual Acuity (EDTRS Chart) - Both Eyes | Visual acuity will be assessed, for all subjects and both eyes using an EDTRS chart (visual acuity is scored with reference to the logarithm of the minimum angle of resolution, 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) | A total of 105 healthy men and women were planned and enrolled included in the study. Initially, local tolerability and safety was evaluated in the first 20 enrolled subjects . After the first 20 subjects had completed the study, local tolerability and safety data were evaluated and treatment safety was confirmed according to the clinical study protocol specifications. Efficacy, beside local tolerability and safety, was assessed in the 85 subsequent subjects | Posted | Mean | Standard Deviation | LogMAR | Up to day 7 |
|
|
|
| Secondary | Ocular Symptoms | The ocular symptoms will be assessed: burning, stinging, itching, foreign body sensation. Scores will be determined using a 100 mm VAS where 0 means "no symptoms" and 100 means "worst possible discomfort". | Posted | Mean | Standard Deviation | mm | Up to day 7 |
|
|
|
| Secondary | Ocular Signs by Slit Lamp Examination | Slit lamp biomicroscopy will be performed for the assessment of the following parameters: conjunctival redness, anterior chamber flare, conjunctival chemosis, eyelid swelling. Presence and severity will be graded according to a 4 point scale, where (0) none, (1) mild, (2) moderate, (3) severe. | Posted | Mean | Standard Deviation | score on a scale | Up to day 7 |
|
|
|
| Secondary | Corneal Fluorescein Staining by Slit Lamp Examination - Both Eyes | Fluorescein will be used to detect corneal epithelial defects using slit lamp biomicroscopy. As grading scale for corneal damage, the NEI/Industry Workshop guidelines will be used. The cornea will be divided into five sectors (central, superior, inferior, nasal and temporal), each of which is scored on a scale of 0-3, where 0 means no staining and 3 means maximum staining, with a maximal score of 15. | Posted | Mean | Standard Deviation | score on a scale | Up to day 7 |
|
|
|
| Secondary | Intraocular Pressure (IOP) - Both Eyes | Intraocular pressure will be measured with a slit-lamp mounted Goldmann applanation tonometer. Before each measurement one drop of oxybuprocaine hydrochloride combined with sodium fluorescein will be used for local anaesthesia of the cornea. | Posted | Mean | Standard Deviation | mm Hg | Up to day 7 |
|
|
|
| Secondary | Fundus Ophthalmoscopy (Vitreous, Macula, Retina and Optic Nerve Head) With the Slit Lamp - Both Eyes | Indirect fundus ophthalmoscopy will be performed, for all subjects and both eyes, with the observation at the slit lamp using a +90 diopters Volk lens.The evaluation is performed with a grading scale: 0 None, 1 Mild, 2 Moderate, 3 Severe for each parameters evaluated. | Initially, safety and local tolerability were evaluated and confirmed in the first 20 enrolled subjects. Then efficacy, beside local tolerability and safety, was assessed in the 85 additional subjects | Posted | Mean | Standard Deviation | score on a scale | Up to day 7 |
|
|
|
| Secondary | Vital Signs (Blood Pressure) | Subjects blood pressure will be measured by the Investigator or his/her deputy | Posted | Mean | Standard Deviation | mmHg | Up to day 7 |
|
|
|
| Secondary | Vital Signs (Heart Rate) | Subjects heart rate will be measured by the Investigator or his/her deputy | Posted | Mean | Standard Deviation | beats/minute | Up to day 7 |
|
|
|
| 0 |
| 84 |
| 0 |
| 84 |
| 27 |
| 84 |
| EG001 | Placebo | Vehicle for chloroprocaine 3% ocular gel, 3 drops instilled at a 1 min ± 15 sec interval. Ocular gel: 3 drops instilled in the right eye | 0 | 21 | 0 | 21 | 4 | 21 |
| conjunctival Hyperemia | Eye disorders | Systematic Assessment |
|
| puncatte keratitis | Eye disorders | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | Systematic Assessment |
|
| eye pruritus | Eye disorders | Systematic Assessment |
|
| Foreign body sensation in eyes | Eye disorders | Systematic Assessment |
|
| eye irritation | Eye disorders | Systematic Assessment |
|
| eye pain | Eye disorders | Systematic Assessment |
|
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| screening left eye |
|
| follow up left eye |
|
| burning in right eye at post-dose |
|
| burning in right eye at follow-up |
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| Stinging in right eye at screening |
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| Stinging in right eye at pre-dose |
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| Stinging in right eye at post-dose |
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| Stinging in right eye at follow-up |
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| Itching in right eye at screening |
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| Itching in right eye at pre-dose |
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| Itching in right eye at post-dose |
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| Itching in right eye at follow-up |
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| Foreign body sensation in right eye at screening |
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| Foreign body sensation in right eye at pre-dose |
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| Foreign body sensation in right eye at post-dose |
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| Foreign body sensation in right eye at follow-up |
|
| Conjunctival redness scores at post dose |
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| Conjunctival redness scores at follow-up |
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| Anterior chamber flare at screening |
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| Anterior chamber flare at pre-dose |
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| Anterior chamber flare post-dose |
|
| Anterior chamber flare follow-up |
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| Conjunctival chemosis at screening |
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| Conjunctival chemosis at pre-dose |
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| Conjunctival chemosis at post-dose |
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| Conjunctival chemosis at follow-up |
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| Eyelid swelling at screening |
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| Eyelid swelling at pre-dose |
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| Eyelid swelling post-dose |
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| Eyelid swelling at follow-up |
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| screening - left eye |
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| follow-up - left eye |
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| left eye at screening |
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| left eye at follow-up |
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| Vitreous scores in left eye at screening |
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| Vitreous scores in left eye at follow up |
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| Macula, (Peripheral) Retina and Optic Nerve scores in right eye at screening |
|
| Macula, (Peripheral) Retina and Optic Nerve scores in right eye at follow up |
|
| Macula, (Peripheral) Retina and Optic Nerve scores in left eye at screening |
|
| Macula, (Peripheral) Retina and Optic Nerve scores in left eye at follow-up |
|
| diastolic - predose |
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| diastolic - postdose |
|