Trial Outcomes & Findings for Safety and Tolerability of the Ophthalmic Gel PRO-167 Versus Corneregel® on Healthy Subjects. (NCT NCT03520348)
NCT ID: NCT03520348
Last Updated: 2019-07-19
Results Overview
the cells will be measured per square millimeter, it is a continuous variable taken by means of cytology per impression, the normal value is higher than 500 cells per square millimeter
COMPLETED
PHASE1
24 participants
will be evaluated at the end of the treatment at the final visit (day 11)
2019-07-19
Participant Flow
Participant milestones
| Measure |
PRO-167
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom
PRO-167: Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Route of administration: ophthalmic
|
Corneregel®
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.
Corneregel: Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany.
Route of administration: ophthalmic
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Tolerability of the Ophthalmic Gel PRO-167 Versus Corneregel® on Healthy Subjects.
Baseline characteristics by cohort
| Measure |
PRO-167
n=24 eyes
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom
PRO-167: Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Route of administration: ophthalmic
|
Corneregel®
n=24 eyes
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.
Corneregel: Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany.
Route of administration: ophthalmic
|
Total
n=48 eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.25 years
STANDARD_DEVIATION 6.84 • n=99 Participants
|
28.17 years
STANDARD_DEVIATION 4.95 • n=107 Participants
|
28.71 years
STANDARD_DEVIATION 5.90 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Region of Enrollment
Mexico
|
12 participants
n=99 Participants
|
12 participants
n=107 Participants
|
24 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 11)the cells will be measured per square millimeter, it is a continuous variable taken by means of cytology per impression, the normal value is higher than 500 cells per square millimeter
Outcome measures
| Measure |
PRO-167
n=24 eyes
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom
PRO-167: Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Route of administration: ophthalmic
|
Corneregel®
n=24 eyes
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.
Corneregel: Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany.
Route of administration: ophthalmic
|
|---|---|---|
|
Goblet Cell Density (GCD)
|
444 cells/mm^2
Standard Deviation 112.5
|
440 cells/mm^2
Standard Deviation 127.2
|
SECONDARY outcome
Timeframe: during the 11 days of evaluation, including the safety call (day 13).the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent.
Outcome measures
| Measure |
PRO-167
n=12 Participants
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom
PRO-167: Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Route of administration: ophthalmic
|
Corneregel®
n=12 Participants
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.
Corneregel: Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany.
Route of administration: ophthalmic
|
|---|---|---|
|
Presence of Adverse Events (EAS)
|
7 cases
|
6 cases
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 11)Population: the statistical analysis of the sample was carried out by protocol
the intraocular pressure will be evaluated by means of the Goldman applanation tonometry whose unit of measurement is millimeters of mercury (mmHg), it is a continuous variable and its normality range is between 11 - 21 mmHg
Outcome measures
| Measure |
PRO-167
n=24 eyes
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom
PRO-167: Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Route of administration: ophthalmic
|
Corneregel®
n=24 eyes
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.
Corneregel: Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany.
Route of administration: ophthalmic
|
|---|---|---|
|
Intraocular Pressure (IOP)
|
13.14 mmHg
Standard Deviation 2.22
|
13.56 mmHg
Standard Deviation 1.99
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 11)Population: the statistical analysis of the sample was carried out by protocol
breakup time lacrimal film 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 greater than 10 seconds.
Outcome measures
| Measure |
PRO-167
n=24 eyes
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom
PRO-167: Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Route of administration: ophthalmic
|
Corneregel®
n=24 eyes
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.
Corneregel: Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany.
Route of administration: ophthalmic
|
|---|---|---|
|
Breakup Time (BUT)
|
8.92 seconds
Standard Deviation 2.1
|
7.75 seconds
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 11)Population: the statistical analysis of the sample was carried out by protocol
The chemosis will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent.
Outcome measures
| Measure |
PRO-167
n=24 eyes
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom
PRO-167: Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Route of administration: ophthalmic
|
Corneregel®
n=24 eyes
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.
Corneregel: Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany.
Route of administration: ophthalmic
|
|---|---|---|
|
Chemosis
|
0 cases
|
0 cases
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 11)Population: the statistical analysis of the sample was carried out by protocol
ocular burning is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time.
Outcome measures
| Measure |
PRO-167
n=24 eyes
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom
PRO-167: Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Route of administration: ophthalmic
|
Corneregel®
n=24 eyes
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.
Corneregel: Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany.
Route of administration: ophthalmic
|
|---|---|---|
|
Ocular Burning (OB)
Absent
|
66.7 percentage of participants
|
75 percentage of participants
|
|
Ocular Burning (OB)
mild
|
29.2 percentage of participants
|
16 percentage of participants
|
|
Ocular Burning (OB)
moderate
|
4.2 percentage of participants
|
8.3 percentage of participants
|
|
Ocular Burning (OB)
Severe
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 11)Population: the statistical analysis of the sample was carried out by protocol
The epithelial defects will be evaluated by means of two stains, green lissamine, 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.
Outcome measures
| Measure |
PRO-167
n=12 Participants
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom
PRO-167: Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Route of administration: ophthalmic
|
Corneregel®
n=24 eyes
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.
Corneregel: Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany.
Route of administration: ophthalmic
|
|---|---|---|
|
Epithelial Defects (ED)
grade 0
|
8 cases
|
8 cases
|
|
Epithelial Defects (ED)
grade I
|
4 cases
|
3 cases
|
|
Epithelial Defects (ED)
grade II
|
0 cases
|
1 cases
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 11)Population: the statistical analysis of the sample was carried out by protocol
Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very Light / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological.
Outcome measures
| Measure |
PRO-167
n=24 eyes
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom
PRO-167: Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Route of administration: ophthalmic
|
Corneregel®
n=24 eyes
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.
Corneregel: Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany.
Route of administration: ophthalmic
|
|---|---|---|
|
Conjunctival Hyperemia (CH)
Normal
|
16.7 percentage of participants
|
8.3 percentage of participants
|
|
Conjunctival Hyperemia (CH)
Very mild
|
66.6 percentage of participants
|
66.7 percentage of participants
|
|
Conjunctival Hyperemia (CH)
Mild
|
16.7 percentage of participants
|
25 percentage of participants
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 11)Population: the statistical analysis of the sample was carried out by protocol
Foreign body sensation is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent. Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time.
Outcome measures
| Measure |
PRO-167
n=24 eyes
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom
PRO-167: Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Route of administration: ophthalmic
|
Corneregel®
n=24 eyes
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.
Corneregel: Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany.
Route of administration: ophthalmic
|
|---|---|---|
|
Foreign Body Sensation (FBS)
Absent
|
79.2 percentage of participants
|
91.7 percentage of participants
|
|
Foreign Body Sensation (FBS)
Very mild
|
20.8 percentage of participants
|
8.3 percentage of participants
|
|
Foreign Body Sensation (FBS)
Mild
|
0 percentage of participants
|
0 percentage of participants
|
|
Foreign Body Sensation (FBS)
Moderate
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 11)Population: the statistical analysis of the sample was carried out by protocol
Ocular pruritus is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent. Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time.
Outcome measures
| Measure |
PRO-167
n=24 eyes
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom
PRO-167: Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Route of administration: ophthalmic
|
Corneregel®
n=24 eyes
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.
Corneregel: Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany.
Route of administration: ophthalmic
|
|---|---|---|
|
Ocular Pruritus (P)
Moderate
|
0 percentage of participants
|
0 percentage of participants
|
|
Ocular Pruritus (P)
Absent
|
41.7 percentage of participants
|
66.7 percentage of participants
|
|
Ocular Pruritus (P)
Very mild
|
50 percentage of participants
|
16.7 percentage of participants
|
|
Ocular Pruritus (P)
Mild
|
8.3 percentage of participants
|
16.7 percentage of participants
|
Adverse Events
PRO-167
Corneregel®
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PRO-167
n=12 participants at risk
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom
PRO-167: Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Route of administration: ophthalmic
|
Corneregel®
n=12 participants at risk
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.
Corneregel: Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany.
Route of administration: ophthalmic
|
|---|---|---|
|
General disorders
headache
|
16.7%
2/12 • Number of events 2 • Adverse events were monitored for a total of 13 days, including the scrutiny visit (day 0) until the safety call (day 13)
|
8.3%
1/12 • Number of events 1 • Adverse events were monitored for a total of 13 days, including the scrutiny visit (day 0) until the safety call (day 13)
|
|
Respiratory, thoracic and mediastinal disorders
rhinitis
|
16.7%
2/12 • Number of events 2 • Adverse events were monitored for a total of 13 days, including the scrutiny visit (day 0) until the safety call (day 13)
|
8.3%
1/12 • Number of events 1 • Adverse events were monitored for a total of 13 days, including the scrutiny visit (day 0) until the safety call (day 13)
|
|
Ear and labyrinth disorders
earache
|
8.3%
1/12 • Number of events 1 • Adverse events were monitored for a total of 13 days, including the scrutiny visit (day 0) until the safety call (day 13)
|
0.00%
0/12 • Adverse events were monitored for a total of 13 days, including the scrutiny visit (day 0) until the safety call (day 13)
|
|
Gastrointestinal disorders
dysgeusia
|
0.00%
0/12 • Adverse events were monitored for a total of 13 days, including the scrutiny visit (day 0) until the safety call (day 13)
|
8.3%
1/12 • Number of events 1 • Adverse events were monitored for a total of 13 days, including the scrutiny visit (day 0) until the safety call (day 13)
|
|
Gastrointestinal disorders
non-infectious diarrhea
|
0.00%
0/12 • Adverse events were monitored for a total of 13 days, including the scrutiny visit (day 0) until the safety call (day 13)
|
16.7%
2/12 • Number of events 2 • Adverse events were monitored for a total of 13 days, including the scrutiny visit (day 0) until the safety call (day 13)
|
|
Immune system disorders
Food Allergy
|
0.00%
0/12 • Adverse events were monitored for a total of 13 days, including the scrutiny visit (day 0) until the safety call (day 13)
|
8.3%
1/12 • Number of events 1 • Adverse events were monitored for a total of 13 days, including the scrutiny visit (day 0) until the safety call (day 13)
|
|
Eye disorders
eyelid bruise
|
8.3%
1/12 • Number of events 1 • Adverse events were monitored for a total of 13 days, including the scrutiny visit (day 0) until the safety call (day 13)
|
0.00%
0/12 • Adverse events were monitored for a total of 13 days, including the scrutiny visit (day 0) until the safety call (day 13)
|
|
Eye disorders
Ocular burning
|
33.3%
4/12 • Number of events 4 • Adverse events were monitored for a total of 13 days, including the scrutiny visit (day 0) until the safety call (day 13)
|
25.0%
3/12 • Number of events 3 • Adverse events were monitored for a total of 13 days, including the scrutiny visit (day 0) until the safety call (day 13)
|
|
Gastrointestinal disorders
elevated liver enzymes
|
8.3%
1/12 • Number of events 1 • Adverse events were monitored for a total of 13 days, including the scrutiny visit (day 0) until the safety call (day 13)
|
0.00%
0/12 • Adverse events were monitored for a total of 13 days, including the scrutiny visit (day 0) until the safety call (day 13)
|
Additional Information
Ricardo Alonso Llamas Velázquez (clinical safety pharmacologist)
Laboratorios Sophia
Results disclosure agreements
- Principal investigator is a sponsor employee Researchers can not disseminate research results unless they obtain written authorization from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER