Trial Outcomes & Findings for Safety and Tolerability of the Ophthalmic Solution PRO-156 in Ophthalmologically Healthy Volunteers. (NCT NCT01871077)

Last Updated: 2019-10-25

Results Overview

The VA will be evaluated basally, without refractive correction with the Snellen chart. A Snellen chart is placed at a standard distance: 20 ft. At this distance, the symbols on the line representing "normal" acuity subtend. This line, designated 20/20 is the smallest line that a person with normal acuity can read at a distance of 20fs. the scale consists of 11 lines of letters of different size, the size of the letter gives a fractional value according to the visual acuity of the patient, the value is inversely proportional to the visual acuity, if the denominator is greater the visual acuity will be less. Line 1: 20/200 Line 2: 20/100, Line 3: 20/70, line 4: 20/50, line 5: 20/40, Line 6: 20/30, line 7: 20/25, Line 8: 20/20, line 9: 20/15, line 10: 20/13, line 11: 20/10. the results will be expressed as the mean of the denominator of the Snellen scale (scale 20/--) example. 18.5 ± 1.5, that means the final result is 20/18.5 ± 1.5

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

30 participants

Primary outcome timeframe

11 days

Results posted on

2019-10-25

Participant Flow

A total of 32 ophthalmologically healthy volunteers were evaluated, to which both eyes, with no history of any systemic or ophthalmological disease, who were not using any type of medication, and who agreed to participate in the study and met all the inclusion criteria described in the section.

Only 30 were selected and 2 discarded because they met the exclusion criteria.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	PRO-156 Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days. PRO-156: Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.
Overall Study STARTED	30 60
Overall Study COMPLETED	30 60
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Tolerability of the Ophthalmic Solution PRO-156 in Ophthalmologically Healthy Volunteers.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PRO-156 n=60 eyes Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days. PRO-156: Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.
Age, Continuous	27 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Race (NIH/OMB) Race · American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Race · Asian	0 Participants n=5 Participants
Race (NIH/OMB) Race · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Race · Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) Race · White	0 Participants n=5 Participants
Race (NIH/OMB) Race · More than one race	30 Participants n=5 Participants
Race (NIH/OMB) Race · Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Mexico	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 11 days

Population: the analysis by treatment of the research subjects was carried out

Outcome measures

Outcome measures
Measure	PRO-156 n=60 eyes Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days. PRO-156: Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.
Visual Acuity (VA) basal visit	19.9 score on a scale Standard Deviation 1.2
Visual Acuity (VA) Final visit	19.83 score on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 11 days

Population: the analysis of the study population was by protocol with Wilcoxon test

The tension of a healthy eye should be between 10 and 20 millimeters of mercury (mmHg). In Goldman-type Applying Tonometry, the cornea is flattened, and the intraocular pressure is determined by measuring the force of application and the flattened area.

Outcome measures

Outcome measures
Measure	PRO-156 n=60 eyes Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days. PRO-156: Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.
Intraocular Pressure (IOP) Final visit	12.23 mmHg Standard Deviation 2.47
Intraocular Pressure (IOP) basal visit	12.60 mmHg Standard Deviation 2.47

SECONDARY outcome

Timeframe: 11 days

Population: the statistical analysis was performed by protocol

the number of epithelial defects was evaluated by the application of fluorescein, Staining was performed with fluorescein which stained the degenerated cells and the mucus filaments present in the tear film.

Outcome measures

Outcome measures
Measure	PRO-156 n=60 eyes Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days. PRO-156: Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.
Number of Eyes With Epithelial Defects	0 eyes

SECONDARY outcome

Timeframe: 11 days

Population: the statistical analysis was performed by protocol

The presence of adverse events was evaluated by the number of cases.

Outcome measures

Outcome measures
Measure	PRO-156 n=60 eyes Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days. PRO-156: Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.
Number of Cases With Adverse Events	6 cases

Adverse Events

PRO-156

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PRO-156 n=30 participants at risk Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days. PRO-156: Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.
Skin and subcutaneous tissue disorders rash	3.3% 1/30 • Number of events 32 • The evaluation period was throughout the study (13 days) comprising 11 days of intervention plus 2 days of safety call
Eye disorders ocular burning	13.3% 4/30 • Number of events 4 • The evaluation period was throughout the study (13 days) comprising 11 days of intervention plus 2 days of safety call
Eye disorders Tearing	6.7% 2/30 • Number of events 2 • The evaluation period was throughout the study (13 days) comprising 11 days of intervention plus 2 days of safety call
Eye disorders Red Eye	6.7% 2/30 • Number of events 2 • The evaluation period was throughout the study (13 days) comprising 11 days of intervention plus 2 days of safety call
Eye disorders eye pruritus	13.3% 4/30 • Number of events 4 • The evaluation period was throughout the study (13 days) comprising 11 days of intervention plus 2 days of safety call
Eye disorders Foreign body sensation in the eyes	6.7% 2/30 • Number of events 2 • The evaluation period was throughout the study (13 days) comprising 11 days of intervention plus 2 days of safety call

Additional Information

PhD. Ricardo Llamas

Laboratorios Sophia

Phone: +52 (33) 3001 4200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee by contract only the sponsor has the rights to the results of the study, if the principal researcher wishes the publication or discuss for dissemination of the same can only perform them prior written authorization with the sponsor and its legal department.
Publication restrictions are in place

Restriction type: OTHER