Trial Outcomes & Findings for Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno® (NCT NCT03966365)
NCT ID: NCT03966365
Last Updated: 2019-12-13
Results Overview
primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent. it will be evaluated by the number of reported cases per group.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
during the 14 days of evaluation, including the safety call (day 14)
Results posted on
2019-12-13
Participant Flow
Participant milestones
| Measure |
PRO-122
\- Dosage: 1 drop every 12 hours, in both eyes
PRO-122: - PRO-122. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution free of preservatives. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- Route of administration: topical ophthalmic.
|
Krytantek Ofteno®
\- Dosage: 1 drop every 12 hours, in both eyes
Krytantek Ofteno®: - - 1. Krytantek Ofteno®. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- - Route of administration: topical ophthalmic.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
PRO-122
\- Dosage: 1 drop every 12 hours, in both eyes
PRO-122: - PRO-122. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution free of preservatives. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- Route of administration: topical ophthalmic.
|
Krytantek Ofteno®
\- Dosage: 1 drop every 12 hours, in both eyes
Krytantek Ofteno®: - - 1. Krytantek Ofteno®. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- - Route of administration: topical ophthalmic.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno®
Baseline characteristics by cohort
| Measure |
PRO-122
n=12 Participants
\- Dosage: 1 drop every 12 hours, in both eyes
PRO-122: - PRO-122. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution free of preservatives. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- Route of administration: topical ophthalmic.
|
Krytantek Ofteno®
n=12 Participants
\- Dosage: 1 drop every 12 hours, in both eyes
Krytantek Ofteno®: - - 1. Krytantek Ofteno®. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- - Route of administration: topical ophthalmic.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.1 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
27.6 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
26.3 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latin
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: during the 14 days of evaluation, including the safety call (day 14)Population: The statistical analysis was by intention to treat (ITT)
primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent. it will be evaluated by the number of reported cases per group.
Outcome measures
| Measure |
PRO-122
n=12 Participants
\- Dosage: 1 drop every 12 hours, in both eyes
PRO-122: - PRO-122. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution free of preservatives. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- Route of administration: topical ophthalmic.
|
Krytantek Ofteno®
n=12 Participants
\- Dosage: 1 drop every 12 hours, in both eyes
Krytantek Ofteno®: - - 1. Krytantek Ofteno®. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- - Route of administration: topical ophthalmic.
|
|---|---|---|
|
Number of Adverse Events
|
28 adverse events
|
31 adverse events
|
PRIMARY outcome
Timeframe: will be evaluated at the end of the treatment, at the final visit (day 8)Population: Analysis per protocol (PP)
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).The Eye comfort index contains items that focus on the discomfort associated with alterations of the ocular surface. Values closer or equal to one hundred (100) correspond to greater discomfort, while values closer or equal to zero (0) correspond to greater comfort.
Outcome measures
| Measure |
PRO-122
n=12 Participants
\- Dosage: 1 drop every 12 hours, in both eyes
PRO-122: - PRO-122. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution free of preservatives. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- Route of administration: topical ophthalmic.
|
Krytantek Ofteno®
n=12 Participants
\- Dosage: 1 drop every 12 hours, in both eyes
Krytantek Ofteno®: - - 1. Krytantek Ofteno®. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- - Route of administration: topical ophthalmic.
|
|---|---|---|
|
Eye Comfort Index
|
24.6 units on a scale
Standard Deviation 12.6
|
27.0 units on a scale
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment, at the final visit (day 8)Population: The statistical analysis was per protocol (PP)
The epithelial defects will be evaluated by means of two stains, green lissamine 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-122
n=22 eyes
\- Dosage: 1 drop every 12 hours, in both eyes
PRO-122: - PRO-122. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution free of preservatives. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- Route of administration: topical ophthalmic.
|
Krytantek Ofteno®
n=24 eyes
\- Dosage: 1 drop every 12 hours, in both eyes
Krytantek Ofteno®: - - 1. Krytantek Ofteno®. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- - Route of administration: topical ophthalmic.
|
|---|---|---|
|
Number of Eyes With Epithelial Defects by Grade
Green lissamine grade 0
|
20 eyes
|
16 eyes
|
|
Number of Eyes With Epithelial Defects by Grade
Green lissamine grade 1
|
2 eyes
|
4 eyes
|
|
Number of Eyes With Epithelial Defects by Grade
Green lissamine grade 2
|
0 eyes
|
4 eyes
|
|
Number of Eyes With Epithelial Defects by Grade
Green lissamine grade 3
|
0 eyes
|
0 eyes
|
|
Number of Eyes With Epithelial Defects by Grade
Green lissamine grade 4
|
0 eyes
|
0 eyes
|
|
Number of Eyes With Epithelial Defects by Grade
Fluorescein grade 0
|
22 eyes
|
22 eyes
|
|
Number of Eyes With Epithelial Defects by Grade
Fluorescein grade 1
|
0 eyes
|
2 eyes
|
|
Number of Eyes With Epithelial Defects by Grade
Fluorescein grade 2
|
0 eyes
|
0 eyes
|
|
Number of Eyes With Epithelial Defects by Grade
Fluorescein grade 3
|
0 eyes
|
0 eyes
|
|
Number of Eyes With Epithelial Defects by Grade
Fluorescein grade 4
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment, at the final visit (day 8)Population: the statistical analysis was per protocol (PP)
The visual capacity variable will be reported using as a unit of measure a fraction, this is taken from a visual test with the Snellen primer, it is a Nominal type variable. where the optimal vision is 20/20 or 1.0 in decimal and the worst 20/200 or 0.1 in decimal number. For the appropriate management of the data, the result of the fraction obtained from the snellen scale is transformed to decimals, in this case subjects close to or equal to 1.0 have better visual acuity while subjects close to or equal to 0.1 have worse visual acuity. The decimal equivalence scale is the result of the division of the fraction obtained in the Snellen chart. where 20/20 = 1.0; Do not confuse with Logmar scale where 20/20 = 0.0 Equivalences Snellen Scale = decimals: 20/200=0.1, 20/100=0.2, 20/50=0.4, 20/40=0.5, 20/30=0.66, 20/25=0.8, 20/20=1.0, etc.
Outcome measures
| Measure |
PRO-122
n=11 Participants
\- Dosage: 1 drop every 12 hours, in both eyes
PRO-122: - PRO-122. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution free of preservatives. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- Route of administration: topical ophthalmic.
|
Krytantek Ofteno®
n=12 Participants
\- Dosage: 1 drop every 12 hours, in both eyes
Krytantek Ofteno®: - - 1. Krytantek Ofteno®. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- - Route of administration: topical ophthalmic.
|
|---|---|---|
|
Visual Ability
|
0.949 Decimal score
Standard Deviation 0.11
|
0.907 Decimal score
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment, at the final visit (day 8)Population: the analysis was per 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-122
n=11 Participants
\- Dosage: 1 drop every 12 hours, in both eyes
PRO-122: - PRO-122. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution free of preservatives. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- Route of administration: topical ophthalmic.
|
Krytantek Ofteno®
n=12 Participants
\- Dosage: 1 drop every 12 hours, in both eyes
Krytantek Ofteno®: - - 1. Krytantek Ofteno®. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- - Route of administration: topical ophthalmic.
|
|---|---|---|
|
Participants With Conjunctival Hyperemia (CH) by Grade
Normal (0)
|
10 Participants
|
9 Participants
|
|
Participants With Conjunctival Hyperemia (CH) by Grade
Very mild (1)
|
0 Participants
|
3 Participants
|
|
Participants With Conjunctival Hyperemia (CH) by Grade
Mild (2)
|
1 Participants
|
0 Participants
|
|
Participants With Conjunctival Hyperemia (CH) by Grade
Moderate (3)
|
0 Participants
|
0 Participants
|
|
Participants With Conjunctival Hyperemia (CH) by Grade
Severe (4)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment, at the final visit (day 8)Population: the analysis was per 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-122
n=11 Participants
\- Dosage: 1 drop every 12 hours, in both eyes
PRO-122: - PRO-122. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution free of preservatives. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- Route of administration: topical ophthalmic.
|
Krytantek Ofteno®
n=12 Participants
\- Dosage: 1 drop every 12 hours, in both eyes
Krytantek Ofteno®: - - 1. Krytantek Ofteno®. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- - Route of administration: topical ophthalmic.
|
|---|---|---|
|
Participants With Chemosis
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: will be evaluated at the end of the treatment, at the final visit (day 8)Population: the analysis was per 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-122
n=11 Participants
\- Dosage: 1 drop every 12 hours, in both eyes
PRO-122: - PRO-122. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution free of preservatives. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- Route of administration: topical ophthalmic.
|
Krytantek Ofteno®
n=12 Participants
\- Dosage: 1 drop every 12 hours, in both eyes
Krytantek Ofteno®: - - 1. Krytantek Ofteno®. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- - Route of administration: topical ophthalmic.
|
|---|---|---|
|
Changes in Intraocular Pressure
|
12.32 mmHg
Standard Deviation 2.3
|
11.78 mmHg
Standard Deviation 1.8
|
Adverse Events
PRO-122
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Krytantek Ofteno®
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PRO-122
n=12 participants at risk
\- Dosage: 1 drop every 12 hours, in both eyes
PRO-122: - PRO-122. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution free of preservatives. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- Route of administration: topical ophthalmic.
|
Krytantek Ofteno®
n=12 participants at risk
\- Dosage: 1 drop every 12 hours, in both eyes
Krytantek Ofteno®: - - 1. Krytantek Ofteno®. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
\- - Route of administration: topical ophthalmic.
|
|---|---|---|
|
Eye disorders
ocular burning
|
91.7%
11/12 • Number of events 11 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
91.7%
11/12 • Number of events 11 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
|
Eye disorders
nonspecific conjunctivitis
|
0.00%
0/12 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
|
Skin and subcutaneous tissue disorders
herpes labialis
|
8.3%
1/12 • Number of events 1 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
0.00%
0/12 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
|
Eye disorders
pruritus
|
8.3%
1/12 • Number of events 1 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
16.7%
2/12 • Number of events 2 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
|
Eye disorders
ocular hyperemia
|
16.7%
2/12 • Number of events 2 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
16.7%
2/12 • Number of events 2 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
|
Eye disorders
feeling of sticky eyes
|
0.00%
0/12 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
|
Eye disorders
decreased visual acuity
|
8.3%
1/12 • Number of events 1 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
0.00%
0/12 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
|
Nervous system disorders
headache
|
16.7%
2/12 • Number of events 2 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
rhinitis
|
8.3%
1/12 • Number of events 1 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
0.00%
0/12 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
|
Ear and labyrinth disorders
clogged ear
|
8.3%
1/12 • Number of events 1 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
0.00%
0/12 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
|
Gastrointestinal disorders
stomach ache
|
0.00%
0/12 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
|
Eye disorders
foreign body sensation in eye
|
0.00%
0/12 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
16.7%
2/12 • Number of events 2 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
|
Eye disorders
Dry Eye
|
16.7%
2/12 • Number of events 2 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
|
Eye disorders
eyestrain
|
0.00%
0/12 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
25.0%
3/12 • Number of events 3 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
|
Gastrointestinal disorders
dysgeusia
|
33.3%
4/12 • Number of events 4 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
0.00%
0/12 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
|
Eye disorders
tearing
|
0.00%
0/12 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
16.7%
2/12 • Number of events 2 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
|
Gastrointestinal disorders
dizziness
|
8.3%
1/12 • Number of events 1 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
0.00%
0/12 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
|
Ear and labyrinth disorders
earache
|
0.00%
0/12 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were monitored throughout the study, which lasted about 4 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee only the sponsor has the decision to disseminate or publish the information obtained from the investigation and the PIs involved must submit a formal request to the sponsor if they are willing to disseminate or publish such information, they may only publish them if they have the written authorization of the sponsor (Laboratoios Sophia S.A. de C.V.).
- Publication restrictions are in place
Restriction type: OTHER