Trial Outcomes & Findings for Efficacy, Safety and Local Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers (NCT NCT04779606)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

105 participants

Primary outcome timeframe

Day 1

Results posted on

2021-09-16

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
First Phase: Tolerability and Safety STARTED	16	4
First Phase: Tolerability and Safety COMPLETED	16	4
First Phase: Tolerability and Safety NOT COMPLETED	0	0
Second Phase: Efficacy STARTED	68	17
Second Phase: Efficacy COMPLETED	68	17
Second Phase: Efficacy NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chloroprocaine n=84 Participants 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	Placebo n=21 Participants 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 n=105 Participants Total of all reporting groups
Age, Continuous	38.7 years STANDARD_DEVIATION 10.8 • n=5 Participants	37.3 years STANDARD_DEVIATION 10.9 • n=7 Participants	38.4 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	10 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	11 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	79 Participants n=5 Participants	20 Participants n=7 Participants	99 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Switzerland	84 participants n=5 Participants	21 participants n=7 Participants	105 participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Chloroprocaine n=68 Participants 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	Placebo n=17 Participants 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
Number of Participants Gaining Full Conjunctival Anesthesia of the Ocular Surface	61 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 1

Population: 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

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

Outcome measures

Outcome measures
Measure	Chloroprocaine n=68 Participants 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	Placebo n=17 Participants 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
Time to Anesthesia, Evaluated by Conjunctiva Pinching (0.3-mm Forceps) - Only Study Eye (Right Eye)	2.41 minutes Standard Deviation 2.12	4.49 minutes Standard Deviation 1.44

SECONDARY outcome

Timeframe: Day 1

Population: 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

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

Outcome measures

Outcome measures
Measure	Chloroprocaine n=68 Participants 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	Placebo n=17 Participants 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
Duration of Anesthesia - Only Right Eye	18.3 minutes Standard Deviation 10	19.3 minutes Standard Deviation 14

SECONDARY outcome

Timeframe: Up to day 7

Population: 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

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)

Outcome measures

Outcome measures
Measure	Chloroprocaine n=68 Participants 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	Placebo n=17 Participants 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
Visual Acuity (EDTRS Chart) - Both Eyes screening right eye	1 LogMAR Standard Deviation 0.1	0.9 LogMAR Standard Deviation 0.2
Visual Acuity (EDTRS Chart) - Both Eyes follow up right eye	1 LogMAR Standard Deviation 0.1	1 LogMAR Standard Deviation 0.1
Visual Acuity (EDTRS Chart) - Both Eyes screening left eye	1 LogMAR Standard Deviation 0.2	1 LogMAR Standard Deviation 0.1
Visual Acuity (EDTRS Chart) - Both Eyes follow up left eye	1 LogMAR Standard Deviation 0.1	1 LogMAR Standard Deviation 0.1

SECONDARY outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure	Chloroprocaine n=84 Participants 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	Placebo n=21 Participants 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
Ocular Symptoms burning in right eye at Screening	0 mm Standard Deviation 0	0 mm Standard Deviation 0
Ocular Symptoms burning in right eye at pre-dose	0 mm Standard Deviation 0	0 mm Standard Deviation 0
Ocular Symptoms burning in right eye at post-dose	1.17 mm Standard Deviation 10	0.14 mm Standard Deviation 0.65
Ocular Symptoms burning in right eye at follow-up	1.35 mm Standard Deviation 10.8	0 mm Standard Deviation 0
Ocular Symptoms Stinging in right eye at screening	0 mm Standard Deviation 0	0 mm Standard Deviation 0
Ocular Symptoms Stinging in right eye at pre-dose	0 mm Standard Deviation 0	0 mm Standard Deviation 0
Ocular Symptoms Stinging in right eye at post-dose	0.73 mm Standard Deviation 6.66	0.05 mm Standard Deviation 0.22
Ocular Symptoms Stinging in right eye at follow-up	1.88 mm Standard Deviation 12.51	0 mm Standard Deviation 0
Ocular Symptoms Itching in right eye at screening	0 mm Standard Deviation 0	0 mm Standard Deviation 0
Ocular Symptoms Itching in right eye at pre-dose	0 mm Standard Deviation 0	0 mm Standard Deviation 0
Ocular Symptoms Itching in right eye at post-dose	1.17 mm Standard Deviation 10.05	0.14 mm Standard Deviation 0.65
Ocular Symptoms Itching in right eye at follow-up	1.35 mm Standard Deviation 10.8	0 mm Standard Deviation 0
Ocular Symptoms Foreign body sensation in right eye at screening	0 mm Standard Deviation 0	0 mm Standard Deviation 0
Ocular Symptoms Foreign body sensation in right eye at pre-dose	0 mm Standard Deviation 0	0 mm Standard Deviation 0
Ocular Symptoms Foreign body sensation in right eye at post-dose	0.93 mm Standard Deviation 6.12	0.33 mm Standard Deviation 1.06
Ocular Symptoms Foreign body sensation in right eye at follow-up	1.21 mm Standard Deviation 7.92	0 mm Standard Deviation 0

SECONDARY outcome

Timeframe: 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.

Outcome measures

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Chloroprocaine n=84 Participants 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	Placebo n=21 Participants 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
Corneal Fluorescein Staining by Slit Lamp Examination - Both Eyes Screening - right eye	0 score on a scale Standard Deviation 0.1	0 score on a scale Standard Deviation 0
Corneal Fluorescein Staining by Slit Lamp Examination - Both Eyes follow-up - right eye	0 score on a scale Standard Deviation 0.2	0 score on a scale Standard Deviation 0.2
Corneal Fluorescein Staining by Slit Lamp Examination - Both Eyes screening - left eye	0 score on a scale Standard Deviation 0.2	0 score on a scale Standard Deviation 0
Corneal Fluorescein Staining by Slit Lamp Examination - Both Eyes follow-up - left eye	0 score on a scale Standard Deviation 0.1	0 score on a scale Standard Deviation 0.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Chloroprocaine n=84 Participants 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	Placebo n=21 Participants 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
Intraocular Pressure (IOP) - Both Eyes right eye at screening	12.7 mm Hg Standard Deviation 2.6	13.2 mm Hg Standard Deviation 2.5
Intraocular Pressure (IOP) - Both Eyes right eye at follow-up	12.3 mm Hg Standard Deviation 2.1	12.3 mm Hg Standard Deviation 2.0
Intraocular Pressure (IOP) - Both Eyes left eye at screening	12.5 mm Hg Standard Deviation 2.3	13.5 mm Hg Standard Deviation 2.2
Intraocular Pressure (IOP) - Both Eyes left eye at follow-up	12.4 mm Hg Standard Deviation 2.2	12.6 mm Hg Standard Deviation 2.0

SECONDARY outcome

Timeframe: Up to day 7

Population: 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

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.

Outcome measures

Outcome measures
Measure	Chloroprocaine n=84 Participants 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	Placebo n=21 Participants 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
Fundus Ophthalmoscopy (Vitreous, Macula, Retina and Optic Nerve Head) With the Slit Lamp - Both Eyes Vitreous scores in right eye at screening	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0
Fundus Ophthalmoscopy (Vitreous, Macula, Retina and Optic Nerve Head) With the Slit Lamp - Both Eyes Vitreous scores in right eye at follow up	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0
Fundus Ophthalmoscopy (Vitreous, Macula, Retina and Optic Nerve Head) With the Slit Lamp - Both Eyes Vitreous scores in left eye at screening	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0
Fundus Ophthalmoscopy (Vitreous, Macula, Retina and Optic Nerve Head) With the Slit Lamp - Both Eyes Vitreous scores in left eye at follow up	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0
Fundus Ophthalmoscopy (Vitreous, Macula, Retina and Optic Nerve Head) With the Slit Lamp - Both Eyes Macula, (Peripheral) Retina and Optic Nerve scores in right eye at screening	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0
Fundus Ophthalmoscopy (Vitreous, Macula, Retina and Optic Nerve Head) With the Slit Lamp - Both Eyes Macula, (Peripheral) Retina and Optic Nerve scores in right eye at follow up	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0
Fundus Ophthalmoscopy (Vitreous, Macula, Retina and Optic Nerve Head) With the Slit Lamp - Both Eyes Macula, (Peripheral) Retina and Optic Nerve scores in left eye at screening	0 score on a scale Standard Deviation 0.1	0 score on a scale Standard Deviation 0
Fundus Ophthalmoscopy (Vitreous, Macula, Retina and Optic Nerve Head) With the Slit Lamp - Both Eyes Macula, (Peripheral) Retina and Optic Nerve scores in left eye at follow-up	0 score on a scale Standard Deviation 0.1	0 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Up to day 7

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

Outcome measures

Outcome measures
Measure	Chloroprocaine n=84 Participants 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	Placebo n=21 Participants 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
Vital Signs (Blood Pressure) Systolic - predose	115.6 mmHg Standard Deviation 10.2	120.4 mmHg Standard Deviation 10.4
Vital Signs (Blood Pressure) systolic - postdose	116 mmHg Standard Deviation 11.8	115.3 mmHg Standard Deviation 10.1
Vital Signs (Blood Pressure) diastolic - predose	71.7 mmHg Standard Deviation 11.5	73.5 mmHg Standard Deviation 10.1
Vital Signs (Blood Pressure) diastolic - postdose	72.0 mmHg Standard Deviation 11.5	71 mmHg Standard Deviation 10.6

SECONDARY outcome

Timeframe: Up to day 7

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

Outcome measures

Outcome measures
Measure	Chloroprocaine n=84 Participants 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	Placebo n=21 Participants 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
Vital Signs (Heart Rate) pre-dose	72.7 beats/minute Standard Deviation 10.1	70.7 beats/minute Standard Deviation 10
Vital Signs (Heart Rate) post-dose	68.4 beats/minute Standard Deviation 8.8	67.3 beats/minute Standard Deviation 8.6

Adverse Events

Chloroprocaine

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Chloroprocaine n=84 participants at risk 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	Placebo n=21 participants at risk 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
Eye disorders Mydriasis	19.0% 16/84 • Number of events 16 • 7 days	0.00% 0/21 • 7 days
Eye disorders conjunctival Hyperemia	11.9% 10/84 • Number of events 10 • 7 days	9.5% 2/21 • Number of events 2 • 7 days
Eye disorders puncatte keratitis	7.1% 6/84 • Number of events 6 • 7 days	0.00% 0/21 • 7 days
Eye disorders Conjunctival haemorrhage	6.0% 5/84 • Number of events 5 • 7 days	0.00% 0/21 • 7 days
Eye disorders eye pruritus	1.2% 1/84 • Number of events 1 • 7 days	4.8% 1/21 • Number of events 1 • 7 days
Eye disorders Foreign body sensation in eyes	0.00% 0/84 • 7 days	9.5% 2/21 • Number of events 2 • 7 days
Eye disorders eye irritation	1.2% 1/84 • Number of events 1 • 7 days	0.00% 0/21 • 7 days
Eye disorders eye pain	0.00% 0/84 • 7 days	4.8% 1/21 • Number of events 1 • 7 days

Additional Information

Dr.Elisabetta Donati, Corporate Director Scientific Affairs

Sintetica SA

Phone: +41.91.640.42.50

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Chloroprocaine n=84 Participants 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	Placebo n=21 Participants 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
Ocular Signs by Slit Lamp Examination Anterior chamber flare follow-up	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0
Ocular Signs by Slit Lamp Examination Conjunctival redness scores at screening	0.04 score on a scale Standard Deviation 0.19	0.05 score on a scale Standard Deviation 0.22
Ocular Signs by Slit Lamp Examination Conjunctival redness scores at pre-dose	0.02 score on a scale Standard Deviation 0.15	0 score on a scale Standard Deviation 0
Ocular Signs by Slit Lamp Examination Conjunctival redness scores at post dose	0.29 score on a scale Standard Deviation 0.57	0.14 score on a scale Standard Deviation 0.48
Ocular Signs by Slit Lamp Examination Conjunctival redness scores at follow-up	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0
Ocular Signs by Slit Lamp Examination Anterior chamber flare at screening	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0
Ocular Signs by Slit Lamp Examination Anterior chamber flare at pre-dose	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0
Ocular Signs by Slit Lamp Examination Anterior chamber flare post-dose	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0
Ocular Signs by Slit Lamp Examination Conjunctival chemosis at screening	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0
Ocular Signs by Slit Lamp Examination Conjunctival chemosis at pre-dose	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0
Ocular Signs by Slit Lamp Examination Conjunctival chemosis at post-dose	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0
Ocular Signs by Slit Lamp Examination Conjunctival chemosis at follow-up	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0
Ocular Signs by Slit Lamp Examination Eyelid swelling at screening	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0
Ocular Signs by Slit Lamp Examination Eyelid swelling at pre-dose	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0
Ocular Signs by Slit Lamp Examination Eyelid swelling post-dose	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0
Ocular Signs by Slit Lamp Examination Eyelid swelling at follow-up	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0