Trial Outcomes & Findings for Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers. (NCT NCT01535443)
NCT ID: NCT01535443
Last Updated: 2019-10-16
Results Overview
A Snellen chart is an eye chart that can be used to measure visual acuity. consisting of a scale ranging from 20 to 200, where 20 is the best visual capacity and 200 is the worst
COMPLETED
PHASE1
35 participants
10 days
2019-10-16
Participant Flow
Participant milestones
| Measure |
PRO-155 Ophthalmic Solution 0.09 %
PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
PRO-155 Ophthalmic Solution 0.09 %
PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
|
|---|---|
|
Overall Study
Physician Decision
|
3
|
Baseline Characteristics
Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.
Baseline characteristics by cohort
| Measure |
PRO-155 Ophthalmic Solution 0.09 %
n=35 Participants
PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice to day during 10 days..
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29.8 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 daysPopulation: Per protocol
A Snellen chart is an eye chart that can be used to measure visual acuity. consisting of a scale ranging from 20 to 200, where 20 is the best visual capacity and 200 is the worst
Outcome measures
| Measure |
PRO-155 Ophthalmic Solution 0.09 %
n=68 eyes
PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
|
|---|---|
|
Visual Acuity
right eye
|
20.3 units on a scale
Standard Deviation 1.2
|
|
Visual Acuity
left eye
|
20.2 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Analysis by intention to treat (ITT)
will be reported the presence of adverse events presented in the study group during the intervention period .
Outcome measures
| Measure |
PRO-155 Ophthalmic Solution 0.09 %
n=70 eyes
PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
|
|---|---|
|
Adverse Events
|
1 events
|
SECONDARY outcome
Timeframe: 10 daysAbnormal bores will be reported when assessing the integrity of the posterior segment, the unit of measure will be number of findings.
Outcome measures
| Measure |
PRO-155 Ophthalmic Solution 0.09 %
n=68 eyes
PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
|
|---|---|
|
Findings in Posterior Segment
right eye
|
1 abnormal findings
|
|
Findings in Posterior Segment
left eye
|
1 abnormal findings
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Analyze by intention to treat
Intraocular pressure (IOP) measurement by applanation tonometry. The unit of measurement will be millimeters of mercury (mmhg) the normal range will be considered 11 to 21 mmhg.
Outcome measures
| Measure |
PRO-155 Ophthalmic Solution 0.09 %
n=35 Participants
PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
|
|---|---|
|
Intraocular Pressure (IOP)
right aye
|
13.3 millimeters of mercury (mmhg)
Standard Deviation 2.1
|
|
Intraocular Pressure (IOP)
left eye
|
13.4 millimeters of mercury (mmhg)
Standard Deviation 2
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Intention to treat analysis (ITT)
The red eye will be evaluated by the absence or presence of hyperemia.
Outcome measures
| Measure |
PRO-155 Ophthalmic Solution 0.09 %
n=35 Participants
PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
|
|---|---|
|
Hyperemia
right eye
|
0 eyes
|
|
Hyperemia
left eye
|
0 eyes
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Intention-to-treat analysis (ITT)
Eye ocular burning will be reported according to the following scale: absent, mild, moderate and severe.
Outcome measures
| Measure |
PRO-155 Ophthalmic Solution 0.09 %
n=70 eyes
PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
|
|---|---|
|
Burning
right eye : absent
|
34 eyes
|
|
Burning
right eye : mild
|
0 eyes
|
|
Burning
right eye : moderate
|
0 eyes
|
|
Burning
right eye : severe
|
0 eyes
|
|
Burning
left eye : absent
|
33 eyes
|
|
Burning
left eye : mild
|
0 eyes
|
|
Burning
left eye : moderate
|
0 eyes
|
|
Burning
left eye : severe
|
1 eyes
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Intention-to-treat analysis (ITT)
Tearing will be reported according to the following scale: absent, mild, moderate and severe.
Outcome measures
| Measure |
PRO-155 Ophthalmic Solution 0.09 %
n=70 eyes
PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
|
|---|---|
|
Tearing
right eye : absent
|
34 eyes
|
|
Tearing
right eye : mild
|
0 eyes
|
|
Tearing
right eye : moderate
|
0 eyes
|
|
Tearing
right eye : severe
|
0 eyes
|
|
Tearing
left eye : absent
|
34 eyes
|
|
Tearing
left eye : mild
|
0 eyes
|
|
Tearing
left eye : moderate
|
0 eyes
|
|
Tearing
left eye : severe
|
0 eyes
|
|
Tearing
left eye : Missing data
|
1 eyes
|
|
Tearing
right eye : Missing data
|
1 eyes
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Intention-to-treat analysis (ITT)
Foreign body sensation will be reported according to the following scale: absent, mild, moderate and severe.
Outcome measures
| Measure |
PRO-155 Ophthalmic Solution 0.09 %
n=70 eyes
PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
|
|---|---|
|
Foreign Body Sensation
right eye : absent
|
34 eyes
|
|
Foreign Body Sensation
right eye : mild
|
0 eyes
|
|
Foreign Body Sensation
right eye : moderate
|
0 eyes
|
|
Foreign Body Sensation
right eye : severe
|
0 eyes
|
|
Foreign Body Sensation
left eye : absent
|
34 eyes
|
|
Foreign Body Sensation
left eye : mild
|
0 eyes
|
|
Foreign Body Sensation
left eye : moderate
|
0 eyes
|
|
Foreign Body Sensation
left eye : severe
|
0 eyes
|
|
Foreign Body Sensation
left eye: Missing data
|
1 eyes
|
|
Foreign Body Sensation
right eye : Missing data
|
1 eyes
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Intention-to-treat analysis (ITT)
photophobia will be reported according to the following scale: absent, mild, moderate and severe.
Outcome measures
| Measure |
PRO-155 Ophthalmic Solution 0.09 %
n=70 eyes
PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
|
|---|---|
|
Photophobia
right eye : absent
|
34 eyes
|
|
Photophobia
right eye : mild
|
0 eyes
|
|
Photophobia
right eye : moderate
|
0 eyes
|
|
Photophobia
right eye : severe
|
0 eyes
|
|
Photophobia
left eye : absent
|
34 eyes
|
|
Photophobia
left eye : mild
|
0 eyes
|
|
Photophobia
left eye : moderate
|
0 eyes
|
|
Photophobia
left eye : severe
|
0 eyes
|
|
Photophobia
left eye : Missing data
|
1 eyes
|
|
Photophobia
right eye : Missing data
|
1 eyes
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Intention-to-treat analysis (ITT)
chemosis will be reported according to the following scale: absent, mild, moderate and severe.
Outcome measures
| Measure |
PRO-155 Ophthalmic Solution 0.09 %
n=70 eyes
PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
|
|---|---|
|
Chemosis
left eye : Missing data
|
1 eyes
|
|
Chemosis
right eye : Missing data
|
1 eyes
|
|
Chemosis
right eye : absent
|
34 eyes
|
|
Chemosis
right eye : mild
|
0 eyes
|
|
Chemosis
right eye : moderate
|
0 eyes
|
|
Chemosis
right eye : severe
|
0 eyes
|
|
Chemosis
left eye : absent
|
34 eyes
|
|
Chemosis
left eye : mild
|
0 eyes
|
|
Chemosis
left eye : moderate
|
0 eyes
|
|
Chemosis
left eye : severe
|
0 eyes
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Intention-to-treat analysis (ITT)
Corneal damage will be reported by Fluorescein eye staining using the following scale: absent, mild, moderate, and severe.
Outcome measures
| Measure |
PRO-155 Ophthalmic Solution 0.09 %
n=70 eyes
PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
|
|---|---|
|
Corneal Damage by Fluorescein Staining Test
right eye : absent
|
34 eyes
|
|
Corneal Damage by Fluorescein Staining Test
right eye : moderate
|
0 eyes
|
|
Corneal Damage by Fluorescein Staining Test
right eye : severe
|
0 eyes
|
|
Corneal Damage by Fluorescein Staining Test
right eye : mild
|
0 eyes
|
|
Corneal Damage by Fluorescein Staining Test
left eye : absent
|
34 eyes
|
|
Corneal Damage by Fluorescein Staining Test
left eye : mild
|
0 eyes
|
|
Corneal Damage by Fluorescein Staining Test
left eye : moderate
|
0 eyes
|
|
Corneal Damage by Fluorescein Staining Test
left eye : severe
|
0 eyes
|
|
Corneal Damage by Fluorescein Staining Test
left eye : Missing data
|
1 eyes
|
|
Corneal Damage by Fluorescein Staining Test
right eye : Missing data
|
1 eyes
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Intention-to-treat analysis (ITT)
Corneal damage will be reported by lissamine green staining using the following scale: absent, mild, moderate, and severe.
Outcome measures
| Measure |
PRO-155 Ophthalmic Solution 0.09 %
n=70 eyes
PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
|
|---|---|
|
Corneal Damage by Lissamine Green Staining Test
right eye : mild
|
0 eyes
|
|
Corneal Damage by Lissamine Green Staining Test
right eye : moderate
|
0 eyes
|
|
Corneal Damage by Lissamine Green Staining Test
right eye : absent
|
34 eyes
|
|
Corneal Damage by Lissamine Green Staining Test
right eye : severe
|
0 eyes
|
|
Corneal Damage by Lissamine Green Staining Test
left eye : absent
|
34 eyes
|
|
Corneal Damage by Lissamine Green Staining Test
left eye : mild
|
0 eyes
|
|
Corneal Damage by Lissamine Green Staining Test
left eye : moderate
|
0 eyes
|
|
Corneal Damage by Lissamine Green Staining Test
left eye : severe
|
0 eyes
|
|
Corneal Damage by Lissamine Green Staining Test
left eye : Missing data
|
1 eyes
|
|
Corneal Damage by Lissamine Green Staining Test
right eye : Missing data
|
1 eyes
|
Adverse Events
PRO-155 Ophthalmic Solution 0.09 %
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Baiza-Duran Leopoldo, Medial Director
Laboratorios Sophia, SA de CV
Results disclosure agreements
- Principal investigator is a sponsor employee All the information is confidential and exclusive property of the sponsor. Information can be revealed only to my staff and regulatory agencies or ethics committee. All the information from this protocol is confidential and exclusive property of the sponsor, it can not be revealed without written consent from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER