Trial Outcomes & Findings for Safety and Tolerability of the Ophthalmic Gel PRO-165 Versus Artelac® Nightime Gel (NCT NCT03697876)
NCT ID: NCT03697876
Last Updated: 2026-01-09
Results Overview
The Principal Investigator will register the Events Adverse (EA) that the subjects of the study will present. The EAs will be expressed as absent or present and the number of cases will be counted by study group.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Throughout the 13 days of evaluation, including the safety call (day 13).
Results posted on
2026-01-09
Participant Flow
Participant milestones
| Measure |
PRO-165
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
PRO-165: PRO-165 Chondroitin sulfate 0.18% / sodium hyaluronate 0.2%, ophthalmic gel. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
|
1. Artelac® Nightime Gel
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
Artelac: Artelac® Nightime Gel. 0.2% Carbomer, ophthalmic gel. Made in Germany by: Dr. Gerhard Mann Chem Pharm. Imported and marketed by: Bausch \& Lomb México, S.A. de C.V.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
Visit 1
|
16
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
PRO-165
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
PRO-165: PRO-165 Chondroitin sulfate 0.18% / sodium hyaluronate 0.2%, ophthalmic gel. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
|
1. Artelac® Nightime Gel
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
Artelac: Artelac® Nightime Gel. 0.2% Carbomer, ophthalmic gel. Made in Germany by: Dr. Gerhard Mann Chem Pharm. Imported and marketed by: Bausch \& Lomb México, S.A. de C.V.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Safety and Tolerability of the Ophthalmic Gel PRO-165 Versus Artelac® Nightime Gel
Baseline characteristics by cohort
| Measure |
PRO-165
n=16 Participants
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
PRO-165: PRO-165 Chondroitin sulfate 0.18% / sodium hyaluronate 0.2%, ophthalmic gel. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
|
1. Artelac® Nightime Gel
n=15 Participants
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
Artelac: Artelac® Nightime Gel. 0.2% Carbomer, ophthalmic gel. Made in Germany by: Dr. Gerhard Mann Chem Pharm. Imported and marketed by: Bausch \& Lomb México, S.A. de C.V.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=8 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=15 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Age, Continuous
|
25.81 years
STANDARD_DEVIATION 4.7 • n=8 Participants
|
28.87 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
27.29 years
STANDARD_DEVIATION 7.0 • n=15 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=8 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=8 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=8 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Region of Enrollment
Mexico
|
16 Participants
n=8 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=15 Participants
|
|
Height
|
1.67 meters
STANDARD_DEVIATION 0.1 • n=8 Participants
|
1.66 meters
STANDARD_DEVIATION 0.1 • n=7 Participants
|
1.66 meters
STANDARD_DEVIATION 0.1 • n=15 Participants
|
|
Weight
|
67.19 kilograms
STANDARD_DEVIATION 9.0 • n=8 Participants
|
69.53 kilograms
STANDARD_DEVIATION 12.3 • n=7 Participants
|
68.32 kilograms
STANDARD_DEVIATION 10.6 • n=15 Participants
|
PRIMARY outcome
Timeframe: Throughout the 13 days of evaluation, including the safety call (day 13).Population: One patient in the PRO-165 group was lost during the course of the study, but did attend to Visit 1, so this subject was included in the ITT population, and therefore considered for the data analysis.
The Principal Investigator will register the Events Adverse (EA) that the subjects of the study will present. The EAs will be expressed as absent or present and the number of cases will be counted by study group.
Outcome measures
| Measure |
PRO-165
n=16 Participants
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
PRO-165: PRO-165 Chondroitin sulfate 0.18% / sodium hyaluronate 0.2%, ophthalmic gel. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
|
1. Artelac® Nightime Gel
n=15 Participants
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
Artelac: Artelac® Nightime Gel. 0.2% Carbomer, ophthalmic gel. Made in Germany by: Dr. Gerhard Mann Chem Pharm. Imported and marketed by: Bausch \& Lomb México, S.A. de C.V.
|
|---|---|---|
|
Adverse Events
|
3 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Baseline Visit (day 0) and Final Visit (day 11)Population: The PP population was considered for this variable's data analysis. One patient in the PRO-165 group was lost during the course of the study, but did attend to Visit 1, so this subject was included in the ITT population (31) but not in the PP (30).
It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100). A higher score is a worse outcome. Similar to the index for ocular surface diseases, the ocular comfort index (ICO) evaluates symptoms. The ICO contains 6 items that focus on the discomfort associated with the ocular surface. Each of these questions has two parts, which inquire separately the frequency and severity of the symptoms. The evaluator will deliver the questionnaire to the subject and allow the subject to answer it calmly without any pressure and / or coercion, will only assist him if he has difficulty understanding any of the questions.
Outcome measures
| Measure |
PRO-165
n=15 Participants
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
PRO-165: PRO-165 Chondroitin sulfate 0.18% / sodium hyaluronate 0.2%, ophthalmic gel. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
|
1. Artelac® Nightime Gel
n=15 Participants
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
Artelac: Artelac® Nightime Gel. 0.2% Carbomer, ophthalmic gel. Made in Germany by: Dr. Gerhard Mann Chem Pharm. Imported and marketed by: Bausch \& Lomb México, S.A. de C.V.
|
|---|---|---|
|
Ocular Comfort Index
Baseline Visit (day 0)
|
20.36 Scores in a Scale
Standard Deviation 13.3
|
15.37 Scores in a Scale
Standard Deviation 14.1
|
|
Ocular Comfort Index
Final Visit (day 11)
|
15.47 Scores in a Scale
Standard Deviation 11.9
|
10.99 Scores in a Scale
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11)Population: The PP population was considered for this variable's data analysis. One patient in the PRO-165 group was lost during the course of the study, but did attend to Visit 1, so this subject was included in the ITT population (31) but not in the PP (30).
Visual acuity (VA) is a test of visual function. It will be evaluated without refractive correction with the Snellen chart. The Snellen chart is the standard tool used to evaluate visual acuity. It was located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20.This score can be expressed in both fraction (i.e. 20/20) or decimal (i.e. 0.5) formats. In this study, VA is expressed in fraction format.
Outcome measures
| Measure |
PRO-165
n=15 Participants
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
PRO-165: PRO-165 Chondroitin sulfate 0.18% / sodium hyaluronate 0.2%, ophthalmic gel. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
|
1. Artelac® Nightime Gel
n=15 Participants
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
Artelac: Artelac® Nightime Gel. 0.2% Carbomer, ophthalmic gel. Made in Germany by: Dr. Gerhard Mann Chem Pharm. Imported and marketed by: Bausch \& Lomb México, S.A. de C.V.
|
|---|---|---|
|
Visual Acuity (VA)
Baseline Visit (day 0)
|
19.33 Decimal Score (Snellen Chart)
Standard Deviation 3.7
|
18.00 Decimal Score (Snellen Chart)
Standard Deviation 2.5
|
|
Visual Acuity (VA)
Visit 1 (day 5)
|
19.33 Decimal Score (Snellen Chart)
Standard Deviation 3.7
|
19.33 Decimal Score (Snellen Chart)
Standard Deviation 3.7
|
|
Visual Acuity (VA)
Final Visit (day 11)
|
20.00 Decimal Score (Snellen Chart)
Standard Deviation 4.6
|
18.67 Decimal Score (Snellen Chart)
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11).Population: The PP population was considered for this variable's data analysis. One patient in the PRO-165 group was lost during the course of the study, but did attend to Visit 1, so this subject was included in the ITT population (31) but not in the PP (30).
Tonometry is the objective measure of Intraocular pressure, based primarily on the force required to flatten the cornea, or the degree of corneal indentation produced by a fixed force. Goldman's tonometry is based on the Imbert-Fick principle. the result will be expressed in millimeters of mercury and the comparison between groups will be carried out.
Outcome measures
| Measure |
PRO-165
n=15 Participants
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
PRO-165: PRO-165 Chondroitin sulfate 0.18% / sodium hyaluronate 0.2%, ophthalmic gel. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
|
1. Artelac® Nightime Gel
n=15 Participants
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
Artelac: Artelac® Nightime Gel. 0.2% Carbomer, ophthalmic gel. Made in Germany by: Dr. Gerhard Mann Chem Pharm. Imported and marketed by: Bausch \& Lomb México, S.A. de C.V.
|
|---|---|---|
|
Intraocular Pressure (IOP)
Baseline Visit (day 0)
|
14.13 mmHg
Standard Deviation 2.8
|
14.20 mmHg
Standard Deviation 3.6
|
|
Intraocular Pressure (IOP)
Visit 1 (day 5)
|
13.73 mmHg
Standard Deviation 2.5
|
13.53 mmHg
Standard Deviation 2.8
|
|
Intraocular Pressure (IOP)
Final Visit (day 11)
|
13.83 mmHg
Standard Deviation 2.5
|
14.00 mmHg
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Final Visit (day 11)The subject will be questioned if after applying the medication he felt burning, pruritus, a foreign body sensation and blurred vision. Presence or absence: it will be marked as present (1) or absent (0) for each of the symptoms questioned
Outcome measures
| Measure |
PRO-165
n=15 Participants
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
PRO-165: PRO-165 Chondroitin sulfate 0.18% / sodium hyaluronate 0.2%, ophthalmic gel. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
|
1. Artelac® Nightime Gel
n=15 Participants
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
Artelac: Artelac® Nightime Gel. 0.2% Carbomer, ophthalmic gel. Made in Germany by: Dr. Gerhard Mann Chem Pharm. Imported and marketed by: Bausch \& Lomb México, S.A. de C.V.
|
|---|---|---|
|
Number of Participants With Post-instillation Symptomatology
Burning sensation
|
4 Participants
|
8 Participants
|
|
Number of Participants With Post-instillation Symptomatology
Pruitus
|
7 Participants
|
6 Participants
|
|
Number of Participants With Post-instillation Symptomatology
Foreign Body Sensation
|
9 Participants
|
8 Participants
|
|
Number of Participants With Post-instillation Symptomatology
Blurry Vision
|
15 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11).Population: One patient in the PRO-165 group was lost during the course of the study, but did attend to Visit 1, so this subject was included in the ITT population (31) but not in the PP (30). The PP population was considered for this variable's data analysis.
Tear Breakup Time (TBUT) is a continuous variable that will be measured in seconds, evaluating the time it takes to break it, is done by direct counting and the normality range and mayor to 10 seconds.
Outcome measures
| Measure |
PRO-165
n=15 Participants
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
PRO-165: PRO-165 Chondroitin sulfate 0.18% / sodium hyaluronate 0.2%, ophthalmic gel. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
|
1. Artelac® Nightime Gel
n=15 Participants
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
Artelac: Artelac® Nightime Gel. 0.2% Carbomer, ophthalmic gel. Made in Germany by: Dr. Gerhard Mann Chem Pharm. Imported and marketed by: Bausch \& Lomb México, S.A. de C.V.
|
|---|---|---|
|
Tear Breakup Time (TBUT)
Baseline Visit (day 0)
|
12.67 Seconds
Standard Deviation 2.9
|
12.80 Seconds
Standard Deviation 3.0
|
|
Tear Breakup Time (TBUT)
Visit 1 (day 5)
|
13.53 Seconds
Standard Deviation 3.4
|
13.47 Seconds
Standard Deviation 3.1
|
|
Tear Breakup Time (TBUT)
Final Visit (day 11)
|
13.47 Seconds
Standard Deviation 3.9
|
13.40 Seconds
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11).Population: One patient in the PRO-165 group was lost during the course of the study, but did attend to Visit 1, so this subject was included in the ITT population (31) but not in the PP (30). The PP population was considered for this variable's data analysis.
The epithelial defects will be evaluated by means of two stains, lysamine green and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the Oxford Scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects. The outcome describes the number of pariticipants who presented which grade according to the Oxford Scale.
Outcome measures
| Measure |
PRO-165
n=15 Participants
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
PRO-165: PRO-165 Chondroitin sulfate 0.18% / sodium hyaluronate 0.2%, ophthalmic gel. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
|
1. Artelac® Nightime Gel
n=15 Participants
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
Artelac: Artelac® Nightime Gel. 0.2% Carbomer, ophthalmic gel. Made in Germany by: Dr. Gerhard Mann Chem Pharm. Imported and marketed by: Bausch \& Lomb México, S.A. de C.V.
|
|---|---|---|
|
Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale)
Lysamine Green Day 0 (Basal Visit) · Grade 0
|
15 Participants
|
15 Participants
|
|
Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale)
Lysamine Green Day 0 (Basal Visit) · Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale)
Lysamine Green; Visit 1 (day 5) · Grade 0
|
15 Participants
|
15 Participants
|
|
Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale)
Lysamine Green; Visit 1 (day 5) · Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale)
Lysamine Green; Final Visit (day 11) · Grade 0
|
15 Participants
|
15 Participants
|
|
Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale)
Lysamine Green; Final Visit (day 11) · Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale)
Fluorescein; Baseline Visit (day 0) · Grade 0
|
15 Participants
|
14 Participants
|
|
Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale)
Fluorescein; Baseline Visit (day 0) · Grade 1
|
0 Participants
|
1 Participants
|
|
Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale)
Fluorescein; Visit 1 (day 5) · Grade 0
|
15 Participants
|
15 Participants
|
|
Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale)
Fluorescein; Visit 1 (day 5) · Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale)
Fluorescein; Final Visit (day 11) · Grade 0
|
15 Participants
|
14 Participants
|
|
Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale)
Fluorescein; Final Visit (day 11) · Grade 1
|
0 Participants
|
1 Participants
|
Adverse Events
PRO-165
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
1. Artelac® Nightime Gel
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PRO-165
n=16 participants at risk
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
PRO-165: PRO-165 Chondroitin sulfate 0.18% / sodium hyaluronate 0.2%, ophthalmic gel. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
|
1. Artelac® Nightime Gel
n=15 participants at risk
Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
Artelac: Artelac® Nightime Gel. 0.2% Carbomer, ophthalmic gel. Made in Germany by: Dr. Gerhard Mann Chem Pharm. Imported and marketed by: Bausch \& Lomb México, S.A. de C.V.
|
|---|---|---|
|
Renal and urinary disorders
Urinary tract infection
|
6.2%
1/16 • Number of events 1 • Adverse Event data were collected until day 13±1 of the study
The Adverse Event Report considered the Intention-To-Treat (ITT) population, (16 for PRO-165 and 15 for Artelac® Nightime Gel; 31 total) all participants who were randomized and exposed to treatment (even one dose). There was one subject from the Artelac® Nightime Gel group who was lost to follow-up and did not attend to any visits beyond scrutiny, so it was impossible to confirm if any exposure to the product had taken place, and therefore not considered in the report.
|
0.00%
0/15 • Adverse Event data were collected until day 13±1 of the study
The Adverse Event Report considered the Intention-To-Treat (ITT) population, (16 for PRO-165 and 15 for Artelac® Nightime Gel; 31 total) all participants who were randomized and exposed to treatment (even one dose). There was one subject from the Artelac® Nightime Gel group who was lost to follow-up and did not attend to any visits beyond scrutiny, so it was impossible to confirm if any exposure to the product had taken place, and therefore not considered in the report.
|
|
Eye disorders
Iriitation in instillation site
|
0.00%
0/16 • Adverse Event data were collected until day 13±1 of the study
The Adverse Event Report considered the Intention-To-Treat (ITT) population, (16 for PRO-165 and 15 for Artelac® Nightime Gel; 31 total) all participants who were randomized and exposed to treatment (even one dose). There was one subject from the Artelac® Nightime Gel group who was lost to follow-up and did not attend to any visits beyond scrutiny, so it was impossible to confirm if any exposure to the product had taken place, and therefore not considered in the report.
|
33.3%
5/15 • Number of events 5 • Adverse Event data were collected until day 13±1 of the study
The Adverse Event Report considered the Intention-To-Treat (ITT) population, (16 for PRO-165 and 15 for Artelac® Nightime Gel; 31 total) all participants who were randomized and exposed to treatment (even one dose). There was one subject from the Artelac® Nightime Gel group who was lost to follow-up and did not attend to any visits beyond scrutiny, so it was impossible to confirm if any exposure to the product had taken place, and therefore not considered in the report.
|
|
Eye disorders
Instillation site lacrimtion
|
0.00%
0/16 • Adverse Event data were collected until day 13±1 of the study
The Adverse Event Report considered the Intention-To-Treat (ITT) population, (16 for PRO-165 and 15 for Artelac® Nightime Gel; 31 total) all participants who were randomized and exposed to treatment (even one dose). There was one subject from the Artelac® Nightime Gel group who was lost to follow-up and did not attend to any visits beyond scrutiny, so it was impossible to confirm if any exposure to the product had taken place, and therefore not considered in the report.
|
6.7%
1/15 • Number of events 1 • Adverse Event data were collected until day 13±1 of the study
The Adverse Event Report considered the Intention-To-Treat (ITT) population, (16 for PRO-165 and 15 for Artelac® Nightime Gel; 31 total) all participants who were randomized and exposed to treatment (even one dose). There was one subject from the Artelac® Nightime Gel group who was lost to follow-up and did not attend to any visits beyond scrutiny, so it was impossible to confirm if any exposure to the product had taken place, and therefore not considered in the report.
|
|
Eye disorders
Dry eye
|
6.2%
1/16 • Number of events 1 • Adverse Event data were collected until day 13±1 of the study
The Adverse Event Report considered the Intention-To-Treat (ITT) population, (16 for PRO-165 and 15 for Artelac® Nightime Gel; 31 total) all participants who were randomized and exposed to treatment (even one dose). There was one subject from the Artelac® Nightime Gel group who was lost to follow-up and did not attend to any visits beyond scrutiny, so it was impossible to confirm if any exposure to the product had taken place, and therefore not considered in the report.
|
0.00%
0/15 • Adverse Event data were collected until day 13±1 of the study
The Adverse Event Report considered the Intention-To-Treat (ITT) population, (16 for PRO-165 and 15 for Artelac® Nightime Gel; 31 total) all participants who were randomized and exposed to treatment (even one dose). There was one subject from the Artelac® Nightime Gel group who was lost to follow-up and did not attend to any visits beyond scrutiny, so it was impossible to confirm if any exposure to the product had taken place, and therefore not considered in the report.
|
|
Eye disorders
Admisnistration site pruritus
|
0.00%
0/16 • Adverse Event data were collected until day 13±1 of the study
The Adverse Event Report considered the Intention-To-Treat (ITT) population, (16 for PRO-165 and 15 for Artelac® Nightime Gel; 31 total) all participants who were randomized and exposed to treatment (even one dose). There was one subject from the Artelac® Nightime Gel group who was lost to follow-up and did not attend to any visits beyond scrutiny, so it was impossible to confirm if any exposure to the product had taken place, and therefore not considered in the report.
|
13.3%
2/15 • Number of events 2 • Adverse Event data were collected until day 13±1 of the study
The Adverse Event Report considered the Intention-To-Treat (ITT) population, (16 for PRO-165 and 15 for Artelac® Nightime Gel; 31 total) all participants who were randomized and exposed to treatment (even one dose). There was one subject from the Artelac® Nightime Gel group who was lost to follow-up and did not attend to any visits beyond scrutiny, so it was impossible to confirm if any exposure to the product had taken place, and therefore not considered in the report.
|
|
Blood and lymphatic system disorders
Eosinophil count Abnormal
|
6.2%
1/16 • Number of events 1 • Adverse Event data were collected until day 13±1 of the study
The Adverse Event Report considered the Intention-To-Treat (ITT) population, (16 for PRO-165 and 15 for Artelac® Nightime Gel; 31 total) all participants who were randomized and exposed to treatment (even one dose). There was one subject from the Artelac® Nightime Gel group who was lost to follow-up and did not attend to any visits beyond scrutiny, so it was impossible to confirm if any exposure to the product had taken place, and therefore not considered in the report.
|
0.00%
0/15 • Adverse Event data were collected until day 13±1 of the study
The Adverse Event Report considered the Intention-To-Treat (ITT) population, (16 for PRO-165 and 15 for Artelac® Nightime Gel; 31 total) all participants who were randomized and exposed to treatment (even one dose). There was one subject from the Artelac® Nightime Gel group who was lost to follow-up and did not attend to any visits beyond scrutiny, so it was impossible to confirm if any exposure to the product had taken place, and therefore not considered in the report.
|
|
Eye disorders
Instillation site foreign body sensation
|
6.2%
1/16 • Number of events 1 • Adverse Event data were collected until day 13±1 of the study
The Adverse Event Report considered the Intention-To-Treat (ITT) population, (16 for PRO-165 and 15 for Artelac® Nightime Gel; 31 total) all participants who were randomized and exposed to treatment (even one dose). There was one subject from the Artelac® Nightime Gel group who was lost to follow-up and did not attend to any visits beyond scrutiny, so it was impossible to confirm if any exposure to the product had taken place, and therefore not considered in the report.
|
6.7%
1/15 • Number of events 1 • Adverse Event data were collected until day 13±1 of the study
The Adverse Event Report considered the Intention-To-Treat (ITT) population, (16 for PRO-165 and 15 for Artelac® Nightime Gel; 31 total) all participants who were randomized and exposed to treatment (even one dose). There was one subject from the Artelac® Nightime Gel group who was lost to follow-up and did not attend to any visits beyond scrutiny, so it was impossible to confirm if any exposure to the product had taken place, and therefore not considered in the report.
|
|
Eye disorders
Blurred vision
|
6.2%
1/16 • Number of events 1 • Adverse Event data were collected until day 13±1 of the study
The Adverse Event Report considered the Intention-To-Treat (ITT) population, (16 for PRO-165 and 15 for Artelac® Nightime Gel; 31 total) all participants who were randomized and exposed to treatment (even one dose). There was one subject from the Artelac® Nightime Gel group who was lost to follow-up and did not attend to any visits beyond scrutiny, so it was impossible to confirm if any exposure to the product had taken place, and therefore not considered in the report.
|
26.7%
4/15 • Number of events 4 • Adverse Event data were collected until day 13±1 of the study
The Adverse Event Report considered the Intention-To-Treat (ITT) population, (16 for PRO-165 and 15 for Artelac® Nightime Gel; 31 total) all participants who were randomized and exposed to treatment (even one dose). There was one subject from the Artelac® Nightime Gel group who was lost to follow-up and did not attend to any visits beyond scrutiny, so it was impossible to confirm if any exposure to the product had taken place, and therefore not considered in the report.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER