Trial Outcomes & Findings for Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification. (NCT NCT04685538)

NCT ID: NCT04685538

Last Updated: 2023-01-18

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 338 participants
• Primary outcome timeframe: Before Intra Ocular Lens (IOL) implantation surgery.
• Results posted on: 2023-01-18

Participant Flow

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

Participant milestones

Measure	Chloroprocaine 3% All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: 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.	Tetracaine 0.5% All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. 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.
Overall Study STARTED	167	171
Overall Study COMPLETED	167	168
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Measure	Chloroprocaine 3% All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: 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.	Tetracaine 0.5% All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. 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.
Overall Study Adverse Event	0	1
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Chloroprocaine 3% n=167 Participants All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: 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.	Tetracaine 0.5% n=171 Participants All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. 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.	Total n=338 Participants Total of all reporting groups
Age, Continuous	70.3 years STANDARD_DEVIATION 10.3 • n=167 Participants	68.8 years STANDARD_DEVIATION 9.9 • n=171 Participants	69.9 years STANDARD_DEVIATION 10.1 • n=338 Participants
Sex: Female, Male Female	94 Participants n=167 Participants	86 Participants n=171 Participants	180 Participants n=338 Participants
Sex: Female, Male Male	73 Participants n=167 Participants	85 Participants n=171 Participants	158 Participants n=338 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Before Intra Ocular Lens (IOL) implantation surgery.

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)

Outcome measures

Measure	Chloroprocaine 3% n=167 Participants All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: 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.	Tetracaine 0.5% n=171 Participants All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. 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.
Number of Participants in Each Treatment Group With a Successful Surface Anesthesia Anesthesia Success	153 participants	152 participants
Number of Participants in Each Treatment Group With a Successful Surface Anesthesia Anesthesia NO Success	14 participants	19 participants

SECONDARY outcome

Timeframe: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

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

Outcome measures

Measure	Chloroprocaine 3% n=167 Participants All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: 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.	Tetracaine 0.5% n=171 Participants All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. 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.
Changes in Ocular Symptoms Foreign Body Sensation visit1	0.08 score on a scale Standard Deviation 0.32	0.06 score on a scale Standard Deviation 0.33
Changes in Ocular Symptoms Foreign Body Sensation visit4	0.19 score on a scale Standard Deviation 0.43	0.17 score on a scale Standard Deviation 0.41
Changes in Ocular Symptoms Irritation/Burning/Stinging visit1	0.11 score on a scale Standard Deviation 0.33	0.11 score on a scale Standard Deviation 0.37
Changes in Ocular Symptoms Irritation/Burning/Stinging visit4	0.11 score on a scale Standard Deviation 0.36	0.15 score on a scale Standard Deviation 0.39
Changes in Ocular Symptoms pain visit1	0.01 score on a scale Standard Deviation 0.11	0.01 score on a scale Standard Deviation 0.08
Changes in Ocular Symptoms pain visit4	0.05 score on a scale Standard Deviation 0.24	0.05 score on a scale Standard Deviation 0.24

SECONDARY outcome

Timeframe: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

• 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

Outcome measures

Measure	Chloroprocaine 3% n=167 Participants All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: 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.	Tetracaine 0.5% n=171 Participants All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. 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.
Objective Ocular Signs Anterior Chamber Cells and Flare visit1	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0
Objective Ocular Signs Anterior Chamber Cells and Flare visit4	0.04 score on a scale Standard Deviation 0.24	0.03 score on a scale Standard Deviation 0.2
Objective Ocular Signs Chemosis visit1	0.03 score on a scale Standard Deviation 0.17	0.04 score on a scale Standard Deviation 0.23
Objective Ocular Signs Chemosis visit4	0.09 score on a scale Standard Deviation 0.33	0.09 score on a scale Standard Deviation 0.33

SECONDARY outcome

Timeframe: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

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).

Outcome measures

Measure	Chloroprocaine 3% n=167 Participants All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: 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.	Tetracaine 0.5% n=171 Participants All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. 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.
Fluoresceine Corneal Fluorescein Staining visit1	0.21 score on a scale Standard Deviation 0.61	0.16 score on a scale Standard Deviation 0.52
Fluoresceine Corneal Fluorescein Staining visit4	0.32 score on a scale Standard Deviation 0.68	0.25 score on a scale Standard Deviation 0.66

SECONDARY outcome

Timeframe: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

Modification of the basal status of the Endothelial cell counts evaluated with the specular microscopy

Outcome measures

Measure	Chloroprocaine 3% n=167 Participants All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: 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.	Tetracaine 0.5% n=171 Participants All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. 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.
Endothelial Cell Counts Endothelial Cells Count [cell/mm2] visit1	2440.76 cell/mm^2 Standard Deviation 378	2511.89 cell/mm^2 Standard Deviation 325.32
Endothelial Cell Counts Endothelial Cells Count [cell/mm2] visit4	2049.88 cell/mm^2 Standard Deviation 620.43	2166.96 cell/mm^2 Standard Deviation 517.41

SECONDARY outcome

Timeframe: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

Modification of the basal status of the assesment (Corneal thickness). Measurement of the central corneal thickness was to be performed with a pachymeter

Outcome measures

Measure	Chloroprocaine 3% n=167 Participants All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: 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.	Tetracaine 0.5% n=171 Participants All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. 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.
Corneal Thickness visit 4 (Day 8 ± 1 day)	557.8 um Standard Deviation 48.8	546.54 um Standard Deviation 42.15
Corneal Thickness visit 1 (Day -90/Day -1)	539.59 um Standard Deviation 39.3	536.59 um Standard Deviation 37.16

SECONDARY outcome

Timeframe: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

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.

Outcome measures

Measure	Chloroprocaine 3% n=167 Participants All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: 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.	Tetracaine 0.5% n=171 Participants All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. 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.
Best Far Corrected Visual Acuity Best Corrected Visual Acuity LogMAR visit1	0.49 LogMAR Standard Deviation 0.31	0.47 LogMAR Standard Deviation 0.32
Best Far Corrected Visual Acuity Best Corrected Visual Acuity LogMAR visit4	0.12 LogMAR Standard Deviation 0.19	0.08 LogMAR Standard Deviation 0.15

SECONDARY outcome

Timeframe: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

Modification of the basal status of the assesment. Dilated fundus examination on retina, macula, optic nerve.

Outcome measures

Measure	Chloroprocaine 3% n=167 Participants All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: 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.	Tetracaine 0.5% n=171 Participants All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. 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.
Number of Participants With Abnormalities of the Retina, Macula, or Optic Nerve by Fundoscopy macula abnormal V1	15 Participants	16 Participants
Number of Participants With Abnormalities of the Retina, Macula, or Optic Nerve by Fundoscopy macula abnormal V4	13 Participants	10 Participants
Number of Participants With Abnormalities of the Retina, Macula, or Optic Nerve by Fundoscopy optic nerve abnormal V1	16 Participants	16 Participants
Number of Participants With Abnormalities of the Retina, Macula, or Optic Nerve by Fundoscopy optic nerve abnormal V4	12 Participants	10 Participants
Number of Participants With Abnormalities of the Retina, Macula, or Optic Nerve by Fundoscopy retina abnormal V1	13 Participants	11 Participants
Number of Participants With Abnormalities of the Retina, Macula, or Optic Nerve by Fundoscopy retina abnormal V4	13 Participants	12 Participants

SECONDARY outcome

Timeframe: Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days

Modification of the basal status of the assesment. Intraocular pressure (in mmHg) was assessed according to site current practice (air puff or applanation tonometer).

Outcome measures

Measure	Chloroprocaine 3% n=167 Participants All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: 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.	Tetracaine 0.5% n=171 Participants All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. 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.
Intra-ocular Pressure visit 1 Selection	15 mmHg Standard Deviation 2.69	15 mmHg Standard Deviation 2.46
Intra-ocular Pressure visit 4 Final	14.7 mmHg Standard Deviation 2.8	14.88 mmHg Standard Deviation 3.05

SECONDARY outcome

Timeframe: day 1 - visit2 (Inclusion visit/Surgery)

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.

Outcome measures

Measure	Chloroprocaine 3% n=167 Participants All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: 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.	Tetracaine 0.5% n=171 Participants All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. 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.
Surgeon Satisfaction	0.17 score on a scale Standard Deviation 0.41	0.17 score on a scale Standard Deviation 0.47

SECONDARY outcome

Timeframe: day 1 - visit2 (Inclusion visit/Surgery) after the treatment

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.

Outcome measures

Measure	Chloroprocaine 3% n=167 Participants All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: 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.	Tetracaine 0.5% n=171 Participants All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. 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.
Patient Global Satisfaction	1.35 score on a scale Standard Deviation 0.66	1.27 score on a scale Standard Deviation 0.52

Adverse Events

Chloroprocaine 3%

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Tetracaine 0.5%

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Chloroprocaine 3% n=167 participants at risk All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria. Chloroprocaine 3%: 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.	Tetracaine 0.5% n=171 participants at risk All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria. 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.
Congenital, familial and genetic disorders corneal Dystrophy	0.00% 0/167 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.58% 1/171 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Eye disorders Conjunctival hemorrhage	0.60% 1/167 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.00% 0/171 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Eye disorders congiunctivitis	0.00% 0/167 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.58% 1/171 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Eye disorders corneal degeneration	0.00% 0/167 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.58% 1/171 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Eye disorders cornela disorder	0.00% 0/167 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.58% 1/171 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Eye disorders corneal edema	3.0% 5/167 • Number of events 5 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	1.2% 2/171 • Number of events 2 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Eye disorders eye discharge	0.00% 0/167 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.58% 1/171 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Eye disorders hyperesthesia	0.60% 1/167 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.00% 0/171 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Eye disorders iridocele	0.00% 0/167 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.58% 1/171 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Eye disorders lens dislocation	0.00% 0/167 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.58% 1/171 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Eye disorders ocular Hypertension	0.00% 0/167 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.58% 1/171 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Eye disorders photophobia	0.60% 1/167 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.58% 1/171 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Eye disorders keratitis	0.60% 1/167 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.58% 1/171 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Eye disorders deformity	0.00% 0/167 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.58% 1/171 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Eye disorders pupillary disorder	0.00% 0/167 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.58% 1/171 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Eye disorders Retinal pigment epitheliopathy	0.60% 1/167 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.00% 0/171 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Eye disorders general disorder	1.2% 2/167 • Number of events 2 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.00% 0/171 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Eye disorders pyrexia	0.60% 1/167 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.00% 0/171 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Eye disorders Sensation of foreign body	0.60% 1/167 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.00% 0/171 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Injury, poisoning and procedural complications edema	0.60% 1/167 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.00% 0/171 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Injury, poisoning and procedural complications procedural pain	0.00% 0/167 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.58% 1/171 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Investigations blood pressure increased	0.00% 0/167 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	1.8% 3/171 • Number of events 3 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Investigations Intraocular pressure increased	0.60% 1/167 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	1.8% 3/171 • Number of events 6 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Nervous system disorders trigeminal neuralgia	0.00% 0/167 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.58% 1/171 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Product Issues devise dislocation	0.60% 1/167 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.00% 0/171 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment
Respiratory, thoracic and mediastinal disorders cough	0.60% 1/167 • Number of events 1 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment	0.00% 0/171 • 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 Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment

Additional Information

Anna Guaita

Sintetica SA

Phone: +41 (0)91 640 42 50

Email: aguaita@sintetica.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place