Efficacy, Safety and Local Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers

• Sponsor: Sintetica SA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04779606
• Collaborator: (none)
• Enrollment: 105
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.1
• Patients Per Site Per Month: 25.4

Study Details

Study Description

Brief Summary

The study evaluate the efficacy, safety and local tolerability of Chloroprocaine 3% ophthalmic gel as compared to matching placebo in healthy subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: Ocular gel	Phase 1/Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase I/II, Randomized, Placebo-controlled, Double-masked, Efficacy, Safety and Local Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers
• Actual Study Start Date: Jun 16, 2020
• Actual Primary Completion Date: Oct 13, 2020
• Actual Study Completion Date: Oct 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chloroprocaine Chloroprocaine 3% ocular gel (30 mg/mL), 3 drops instilled at a 1 min ± 15 sec interval.	Drug: Ocular gel; 3 drops instilled in the right eye; Other Names: No other intervention names
Placebo Comparator: Placebo Vehicle for chloroprocaine 3% ocular gel, 3 drops instilled at a 1 min ± 15 sec interval.	Drug: Ocular gel; 3 drops instilled in the right eye; Other Names: No other intervention names

Outcome Measures

Primary Outcome Measures

1. Number of Participants Gaining Full Conjunctival Anesthesia of the Ocular Surface [Day 1]

   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)

Secondary Outcome Measures

1. Time to Anesthesia, Evaluated by Conjunctiva Pinching (0.3-mm Forceps) - Only Study Eye (Right Eye) [Day 1]

   Time to anesthesia, evaluated by conjunctiva pinching (0.3-mm forceps) - only study eye (right eye)

2. Duration of Anesthesia - Only Right Eye [Day 1]

   Duration of anesthesia, evaluated by conjunctiva pinching (0.3-mm forceps) - only study eye (right eye)

3. Visual Acuity (EDTRS Chart) - Both Eyes [Up to day 7]

   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)

4. Ocular Symptoms [Up to day 7]

   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".

5. Ocular Signs by Slit Lamp Examination [Up to day 7]

   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.

6. Corneal Fluorescein Staining by Slit Lamp Examination - Both Eyes [Up to day 7]

   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.

7. Intraocular Pressure (IOP) - Both Eyes [Up to day 7]

   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.

8. Fundus Ophthalmoscopy (Vitreous, Macula, Retina and Optic Nerve Head) With the Slit Lamp - Both Eyes [Up to day 7]

   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.

9. Vital Signs (Blood Pressure) [Up to day 7]

   Subjects blood pressure will be measured by the Investigator or his/her deputy

10. Vital Signs (Heart Rate) [Up to day 7]

    Subjects heart rate will be measured by the Investigator or his/her deputy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit;

2. A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit

3. A male sexual partner who agrees to use a male condom with spermicide

4. A sterile sexual partner Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all women, urine pregnancy test result must be negative at screening.

Exclusion Criteria:

• Physical findings: Clinically significant abnormal physical findings which could interfere with the objectives of the study

• Visual acuity: Best corrected visual acuity < 1/10

• Concomitant medications: Medications, including over the counter medications and herbal remedies, systemic opioids and morphine drugs, topical ocular products with anaesthetic action, systemic analgesic drugs, for 2 weeks before study screening

• Ophthalmic diseases: Clinically significant ocular disease; eye movement disorder (i.e. nystagmus); dacryocystitis and all others pathologies of tears drainage system; corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis); history of inflammatory ocular disease (iritis, uveitis, herpetic keratitis), history of ocular traumatism, infection or inflammation within the last 3 months or history of any other ocular disease that may affect the outcome of the study or the subject's safety

• Ophthalmic surgery: History of ophthalmic surgical complications (e.g. cystoid macular oedema) in the last 6 months

• Diseases: Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, psychiatric or neurological diseases or surgeries that may interfere with the aim of the study

• Allergy: Ascertained or presumptive hypersensitivity to the active principle and/or ingredients of investigational products; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study

• Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study

• Drug, alcohol, caffeine, tobacco: history of drug, alcohol [greater than 1 drink/day for women and greater than 2 drinks/day for men, defined according to the USDA Dietary Guidelines 2015-2020], caffeine (greater than 5 cups coffee/tea/day) or tobacco abuse (greater than or equal 10 cigarettes/day)

• Alcohol test: positive alcohol breath test at Day 1

• Pregnancy (women only): positive or missing pregnancy test at screening, pregnant or lactating women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CROSS Research S.A.	Arzo		Switzerland

Sponsors and Collaborators

• Sintetica SA

Investigators

• Principal Investigator: Milko Radicioni, CROSS Research S.A., Phase I Clinical Unit, Arzo, Switzerland

Study Documents (Full-Text)

• Study Protocol - Feb 21, 2020
• Statistical Analysis Plan - Nov 20, 2020

More Information

Publications

None provided.

• Responsible Party: Sintetica SA
• ClinicalTrials.gov Identifier: NCT04779606
• Other Study ID Numbers: CHL.3-01-2020
• First Posted: Mar 3, 2021
• Last Update Posted: Sep 16, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	Chloroprocaine	Placebo
Arm/Group Description	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	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
Period Title: First Phase: Tolerability and Safety
STARTED	16	4
COMPLETED	16	4
NOT COMPLETED	0	0
Period Title: First Phase: Tolerability and Safety
STARTED	68	17
COMPLETED	68	17
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Chloroprocaine	Placebo	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	84	21	105
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.7 (10.8)	37.3 (10.9)	38.4 (10.8)
Sex: Female, Male (Count of Participants)
Female	52 61.9%	10 47.6%	62 59%
Male	32 38.1%	11 52.4%	43 41%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 1.2%	0 0%	1 1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	79 94%	20 95.2%	99 94.3%
More than one race	4 4.8%	1 4.8%	5 4.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Switzerland	84 100%	21 100%	105 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Gaining Full Conjunctival Anesthesia of the Ocular Surface
Description	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)
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine	Placebo
Arm/Group Description	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	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
Measure Participants	68	17
Count of Participants [Participants]	61 72.6%	2 9.5%

2. Secondary Outcome

Title	Time to Anesthesia, Evaluated by Conjunctiva Pinching (0.3-mm Forceps) - Only Study Eye (Right Eye)
Description	Time to anesthesia, evaluated by conjunctiva pinching (0.3-mm forceps) - only study eye (right eye)
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Chloroprocaine	Placebo
Arm/Group Description	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	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
Measure Participants	68	17
Mean (Standard Deviation) [minutes]	2.41 (2.12)	4.49 (1.44)

3. Secondary Outcome

Title	Duration of Anesthesia - Only Right Eye
Description	Duration of anesthesia, evaluated by conjunctiva pinching (0.3-mm forceps) - only study eye (right eye)
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Chloroprocaine	Placebo
Arm/Group Description	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	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
Measure Participants	68	17
Mean (Standard Deviation) [minutes]	18.3 (10)	19.3 (14)

4. Secondary Outcome

Title	Visual Acuity (EDTRS Chart) - Both Eyes
Description	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)
Time Frame	Up to day 7

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Chloroprocaine	Placebo
Arm/Group Description	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	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
Measure Participants	68	17
screening right eye	1 (0.1)	0.9 (0.2)
follow up right eye	1 (0.1)	1 (0.1)
screening left eye	1 (0.2)	1 (0.1)
follow up left eye	1 (0.1)	1 (0.1)

5. Secondary Outcome

Title	Ocular Symptoms
Description	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".
Time Frame	Up to day 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine	Placebo
Arm/Group Description	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	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
Measure Participants	84	21
burning in right eye at Screening	0 (0)	0 (0)
burning in right eye at pre-dose	0 (0)	0 (0)
burning in right eye at post-dose	1.17 (10)	0.14 (0.65)
burning in right eye at follow-up	1.35 (10.8)	0 (0)
Stinging in right eye at screening	0 (0)	0 (0)
Stinging in right eye at pre-dose	0 (0)	0 (0)
Stinging in right eye at post-dose	0.73 (6.66)	0.05 (0.22)
Stinging in right eye at follow-up	1.88 (12.51)	0 (0)
Itching in right eye at screening	0 (0)	0 (0)
Itching in right eye at pre-dose	0 (0)	0 (0)
Itching in right eye at post-dose	1.17 (10.05)	0.14 (0.65)
Itching in right eye at follow-up	1.35 (10.8)	0 (0)
Foreign body sensation in right eye at screening	0 (0)	0 (0)
Foreign body sensation in right eye at pre-dose	0 (0)	0 (0)
Foreign body sensation in right eye at post-dose	0.93 (6.12)	0.33 (1.06)
Foreign body sensation in right eye at follow-up	1.21 (7.92)	0 (0)

6. Secondary Outcome

Title	Ocular Signs by Slit Lamp Examination
Description	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.
Time Frame	Up to day 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine	Placebo
Arm/Group Description	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	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
Measure Participants	84	21
Conjunctival redness scores at screening	0.04 (0.19)	0.05 (0.22)
Conjunctival redness scores at pre-dose	0.02 (0.15)	0 (0)
Conjunctival redness scores at post dose	0.29 (0.57)	0.14 (0.48)
Conjunctival redness scores at follow-up	0 (0)	0 (0)
Anterior chamber flare at screening	0 (0)	0 (0)
Anterior chamber flare at pre-dose	0 (0)	0 (0)
Anterior chamber flare post-dose	0 (0)	0 (0)
Anterior chamber flare follow-up	0 (0)	0 (0)
Conjunctival chemosis at screening	0 (0)	0 (0)
Conjunctival chemosis at pre-dose	0 (0)	0 (0)
Conjunctival chemosis at post-dose	0 (0)	0 (0)
Conjunctival chemosis at follow-up	0 (0)	0 (0)
Eyelid swelling at screening	0 (0)	0 (0)
Eyelid swelling at pre-dose	0 (0)	0 (0)
Eyelid swelling post-dose	0 (0)	0 (0)
Eyelid swelling at follow-up	0 (0)	0 (0)

7. Secondary Outcome

Title	Corneal Fluorescein Staining by Slit Lamp Examination - Both Eyes
Description	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.
Time Frame	Up to day 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine	Placebo
Arm/Group Description	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	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
Measure Participants	84	21
Screening - right eye	0 (0.1)	0 (0)
follow-up - right eye	0 (0.2)	0 (0.2)
screening - left eye	0 (0.2)	0 (0)
follow-up - left eye	0 (0.1)	0 (0.2)

8. Secondary Outcome

Title	Intraocular Pressure (IOP) - Both Eyes
Description	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.
Time Frame	Up to day 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine	Placebo
Arm/Group Description	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	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
Measure Participants	84	21
right eye at screening	12.7 (2.6)	13.2 (2.5)
right eye at follow-up	12.3 (2.1)	12.3 (2.0)
left eye at screening	12.5 (2.3)	13.5 (2.2)
left eye at follow-up	12.4 (2.2)	12.6 (2.0)

9. Secondary Outcome

Title	Fundus Ophthalmoscopy (Vitreous, Macula, Retina and Optic Nerve Head) With the Slit Lamp - Both Eyes
Description	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.
Time Frame	Up to day 7

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Chloroprocaine	Placebo
Arm/Group Description	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	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
Measure Participants	84	21
Vitreous scores in right eye at screening	0 (0)	0 (0)
Vitreous scores in right eye at follow up	0 (0)	0 (0)
Vitreous scores in left eye at screening	0 (0)	0 (0)
Vitreous scores in left eye at follow up	0 (0)	0 (0)
Macula, (Peripheral) Retina and Optic Nerve scores in right eye at screening	0 (0)	0 (0)
Macula, (Peripheral) Retina and Optic Nerve scores in right eye at follow up	0 (0)	0 (0)
Macula, (Peripheral) Retina and Optic Nerve scores in left eye at screening	0 (0.1)	0 (0)
Macula, (Peripheral) Retina and Optic Nerve scores in left eye at follow-up	0 (0.1)	0 (0)

10. Secondary Outcome

Title	Vital Signs (Blood Pressure)
Description	Subjects blood pressure will be measured by the Investigator or his/her deputy
Time Frame	Up to day 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine	Placebo
Arm/Group Description	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	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
Measure Participants	84	21
Systolic - predose	115.6 (10.2)	120.4 (10.4)
systolic - postdose	116 (11.8)	115.3 (10.1)
diastolic - predose	71.7 (11.5)	73.5 (10.1)
diastolic - postdose	72.0 (11.5)	71 (10.6)

11. Secondary Outcome

Title	Vital Signs (Heart Rate)
Description	Subjects heart rate will be measured by the Investigator or his/her deputy
Time Frame	Up to day 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine	Placebo
Arm/Group Description	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	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
Measure Participants	84	21
pre-dose	72.7 (10.1)	70.7 (10)
post-dose	68.4 (8.8)	67.3 (8.6)

Adverse Events

Time Frame	7 days
Arm/Group Title	Chloroprocaine		Placebo
Arm/Group Description	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		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
All Cause Mortality
	Chloroprocaine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/84 (0%)		0/21 (0%)
Serious Adverse Events
	Chloroprocaine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/84 (0%)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	Chloroprocaine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	27/84 (32.1%)		4/21 (19%)
Eye disorders
Mydriasis	16/84 (19%)	16	0/21 (0%)	0
conjunctival Hyperemia	10/84 (11.9%)	10	2/21 (9.5%)	2
puncatte keratitis	6/84 (7.1%)	6	0/21 (0%)	0
Conjunctival haemorrhage	5/84 (6%)	5	0/21 (0%)	0
eye pruritus	1/84 (1.2%)	1	1/21 (4.8%)	1
Foreign body sensation in eyes	0/84 (0%)	0	2/21 (9.5%)	2
eye irritation	1/84 (1.2%)	1	0/21 (0%)	0
eye pain	0/84 (0%)	0	1/21 (4.8%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.