Trial Outcomes & Findings for Safety and Tolerability of PRO-087 Versus Xyel Ofteno® and Systane Ultra®, on the Ocular Surface of Healthy Subjects (NCT NCT03524157)
NCT ID: NCT03524157
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
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
will be evaluated at the end of the treatment at the final visit (day 10)
Results posted on
2019-07-19
Participant Flow
Participant milestones
| Measure |
PRO-087
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Xyel Ofteno
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Systane Ultra
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc.
Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
PRO-087
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Xyel Ofteno
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Systane Ultra
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc.
Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
|---|---|---|---|
|
Overall Study
cytology not readable
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Tolerability of PRO-087 Versus Xyel Ofteno® and Systane Ultra®, on the Ocular Surface of Healthy Subjects
Baseline characteristics by cohort
| Measure |
PRO-087
n=10 Participants
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Xyel Ofteno
n=10 Participants
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Systane Ultra
n=9 Participants
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc.
Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28.5 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
27.2 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
28.1 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
27.9 years
STANDARD_DEVIATION 6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Intra Ocular Pressure (IOP)
|
13.6 mmHg
STANDARD_DEVIATION 2.3 • n=5 Participants
|
13.5 mmHg
STANDARD_DEVIATION 2.4 • n=7 Participants
|
13.9 mmHg
STANDARD_DEVIATION 1.6 • n=5 Participants
|
13.7 mmHg
STANDARD_DEVIATION 6.3 • n=4 Participants
|
|
tear film breakup (BUT)
|
8.2 seconds
STANDARD_DEVIATION 2.4 • n=5 Participants
|
8.1 seconds
STANDARD_DEVIATION 2.1 • n=7 Participants
|
9.3 seconds
STANDARD_DEVIATION 2.2 • n=5 Participants
|
8.5 seconds
STANDARD_DEVIATION 2.2 • n=4 Participants
|
|
goblet cells
|
231.4 cells /mm2
STANDARD_DEVIATION 103.9 • n=5 Participants
|
244.2 cells /mm2
STANDARD_DEVIATION 118.5 • n=7 Participants
|
254.1 cells /mm2
STANDARD_DEVIATION 112.9 • n=5 Participants
|
243.2 cells /mm2
STANDARD_DEVIATION 111.8 • n=4 Participants
|
PRIMARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 10)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-087
n=19 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Xyel Ofteno
n=20 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Systane Ultra
n=17 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc.
Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
|---|---|---|---|
|
Goblet Cell Density (GCD)
|
282.5 cells/mm2
Standard Deviation 78.6
|
326.8 cells/mm2
Standard Deviation 125.9
|
291.5 cells/mm2
Standard Deviation 135.3
|
SECONDARY outcome
Timeframe: during the 13 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-087
n=10 Participants
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Xyel Ofteno
n=10 Participants
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Systane Ultra
n=10 Participants
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc.
Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
|---|---|---|---|
|
Presence of Adverse Events (AEs)
|
13 adverse events
|
8 adverse events
|
7 adverse events
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 10)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-087
n=10 Participants
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Xyel Ofteno
n=10 Participants
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Systane Ultra
n=9 Participants
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc.
Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
|---|---|---|---|
|
Intraocular Pressure (IOP)
|
12.80 mmHg
Standard Deviation 1.7
|
12.55 mmHg
Standard Deviation 2.3
|
12.72 mmHg
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 10)The epithelial defects will be evaluated by means of two stains, green lysine 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.
Outcome measures
| Measure |
PRO-087
n=20 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Xyel Ofteno
n=20 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Systane Ultra
n=18 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc.
Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
|---|---|---|---|
|
Epithelial Defects (ED)
grade 0
|
19 eyes
|
16 eyes
|
17 eyes
|
|
Epithelial Defects (ED)
grade I
|
1 eyes
|
3 eyes
|
1 eyes
|
|
Epithelial Defects (ED)
grade II
|
0 eyes
|
1 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 10)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 and mayor to 10 seconds.
Outcome measures
| Measure |
PRO-087
n=20 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Xyel Ofteno
n=20 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Systane Ultra
n=18 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc.
Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
|---|---|---|---|
|
Breakup Time (BUT)
|
8.8 seconds
Standard Deviation 2.1
|
7.3 seconds
Standard Deviation 2.1
|
9.6 seconds
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 10)Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very mild / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Moderate and severe are considered pathological.
Outcome measures
| Measure |
PRO-087
n=20 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Xyel Ofteno
n=20 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Systane Ultra
n=18 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc.
Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
|---|---|---|---|
|
Conjunctival Hyperemia (CH)
Normal
|
19 cases
|
16 cases
|
17 cases
|
|
Conjunctival Hyperemia (CH)
Very mild
|
1 cases
|
3 cases
|
1 cases
|
|
Conjunctival Hyperemia (CH)
Mild
|
0 cases
|
1 cases
|
0 cases
|
|
Conjunctival Hyperemia (CH)
Moderate
|
0 cases
|
0 cases
|
0 cases
|
|
Conjunctival Hyperemia (CH)
Severe
|
0 cases
|
0 cases
|
0 cases
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 10)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-087
n=20 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Xyel Ofteno
n=20 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Systane Ultra
n=18 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc.
Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
|---|---|---|---|
|
Chemosis
|
0 cases
|
0 cases
|
0 cases
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 10)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-087
n=20 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Xyel Ofteno
n=20 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Systane Ultra
n=18 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc.
Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
|---|---|---|---|
|
Ocular Burning (OB)
|
4 cases
|
4 cases
|
0 cases
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 10)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-087
n=20 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Xyel Ofteno
n=20 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Systane Ultra
n=18 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc.
Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
|---|---|---|---|
|
Foreign Body Sensation (FBS)
Mild
|
0 cases
|
0 cases
|
0 cases
|
|
Foreign Body Sensation (FBS)
Severe
|
0 cases
|
0 cases
|
0 cases
|
|
Foreign Body Sensation (FBS)
Absent
|
20 cases
|
16 cases
|
16 cases
|
|
Foreign Body Sensation (FBS)
Very mild
|
0 cases
|
4 cases
|
2 cases
|
|
Foreign Body Sensation (FBS)
Moderate
|
0 cases
|
0 cases
|
0 cases
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 10)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-087
n=20 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Xyel Ofteno
n=20 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Systane Ultra
n=18 eyes
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc.
Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
|---|---|---|---|
|
Ocular Pruritus (P)
Absent
|
18 cases
|
16 cases
|
16 cases
|
|
Ocular Pruritus (P)
Very mild
|
2 cases
|
4 cases
|
2 cases
|
|
Ocular Pruritus (P)
Mild
|
0 cases
|
0 cases
|
0 cases
|
|
Ocular Pruritus (P)
Moderate
|
0 cases
|
0 cases
|
0 cases
|
|
Ocular Pruritus (P)
Severe
|
0 cases
|
0 cases
|
0 cases
|
Adverse Events
PRO-087
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Xyel Ofteno
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Systane Ultra
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-087
n=10 participants at risk
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Xyel Ofteno
n=10 participants at risk
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
Systane Ultra
n=10 participants at risk
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc.
Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13.
|
|---|---|---|---|
|
Nervous system disorders
headache
|
10.0%
1/10 • Number of events 1 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
10.0%
1/10 • Number of events 1 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
10.0%
1/10 • Number of events 1 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
|
Blood and lymphatic system disorders
hypertransaminasemia
|
10.0%
1/10 • Number of events 1 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
10.0%
1/10 • Number of events 1 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
20.0%
2/10 • Number of events 2 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
|
Eye disorders
ocular burning
|
40.0%
4/10 • Number of events 4 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
30.0%
3/10 • Number of events 3 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
10.0%
1/10 • Number of events 1 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
|
Eye disorders
ocular itching
|
40.0%
4/10 • Number of events 4 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
20.0%
2/10 • Number of events 2 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
10.0%
1/10 • Number of events 1 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
|
Eye disorders
ocular discharge
|
10.0%
1/10 • Number of events 1 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
0.00%
0/10 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
10.0%
1/10 • Number of events 1 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
|
Eye disorders
ocular foreign body sensation
|
10.0%
1/10 • Number of events 1 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
0.00%
0/10 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
0.00%
0/10 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
|
Eye disorders
dry eye
|
10.0%
1/10 • Number of events 1 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
0.00%
0/10 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
0.00%
0/10 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
|
Skin and subcutaneous tissue disorders
skin rash
|
0.00%
0/10 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
10.0%
1/10 • Number of events 1 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
0.00%
0/10 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
|
Blood and lymphatic system disorders
hyperglycemia
|
0.00%
0/10 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
0.00%
0/10 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
10.0%
1/10 • Number of events 1 • The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee only the sponsor can publish the information held by the research centers, if the principal investigator of a center wishes to publish the information, it must have the written consent of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER