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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PRO-156

• Registration Number: NCT01871077
• Lead Sponsor: Laboratorios Sophia S.A de C.V.

Brief Summary

The purpose of this study is to evaluate safety and tolerability of the ophthalmic solution PRO-156 over the ocular surface of ophthalmologically healthy volunteers

Detailed Description

A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of the ophthalmic solution PRO-143 over the ocular surface of ophthalmologically healthy volunteers.

Study Timeline

• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-06
• Study Start: 2013-09
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2018-05-23
• Status Verified: 2019-10
• Results First Submitted QC: 2019-10-02
• Last Update Submitted: 2019-10-02
• Results First Posted: 2019-10-25
• Last Update Posted: 2019-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Healthy male and female.
• Age between 18 and 40 years old at screening visit.
• Signed informed consent

Exclusion Criteria

• Patient with one blind eye.
• Any ocular or systemic condition.
• Visual acuity of 20/100 in any eye.
• Use of ocular or systemic medication.
• Contraindications or sensitivity to any component of the study treatment.
• Contact lens users.
• Ocular surgery within the past 3 months..
• Pregnant, nursing or childbearing potential women who were not using effective contraception.
• Participation in any studies of investigational drugs within 90 days previous to the inclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRO-156	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.

Primary Outcome Measures

Name	Time	Method
Visual Acuity (VA)	11 days	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

Secondary Outcome Measures

Name	Time	Method
Number of Cases With Adverse Events	11 days	The presence of adverse events was evaluated by the number of cases.
Intraocular Pressure (IOP)	11 days	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.
Number of Eyes With Epithelial Defects	11 days	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.