Safety and Tolerability of PRO-143 Ophthalmic Solution in Healthy Volunteers.

Sponsor

Laboratorios Sophia S.A de C.V. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT03698045

Collaborator

(none)

Enrollment

Location

Arm

3.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study to evaluate the safety and tolerability of PRO-143 solution ophthalmic in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Conjunctivitis, Bacterial	Drug: PRO-143 Ophthalmic Solution	Phase 1

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Study to Evaluate the Safety and Tolerability of Pro-143 Ophthalmic Solution in Healthy Volunteers.

Study Start Date :

Nov 1, 2013

Anticipated Primary Completion Date :

Feb 1, 2014

Anticipated Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PRO-143 Ophthalmic Solution PRO-143 Ophthalmic Solution applied four times per day (c/6 hours) during 10 days.	Drug: PRO-143 Ophthalmic Solution PRO-143 Ophthalmic Solution applied four times per day (C/6 hours) during 10 days. Other Names: PRO-143

Arm

Intervention/Treatment

Experimental: PRO-143 Ophthalmic Solution

PRO-143 Ophthalmic Solution applied four times per day (c/6 hours) during 10 days.

Drug: PRO-143 Ophthalmic Solution

PRO-143 Ophthalmic Solution applied four times per day (C/6 hours) during 10 days.

Other Names:

PRO-143

Outcome Measures

Primary Outcome Measures

Conjunctival bulbar hyperemia [10 days]
Conjunctival hyperemia is defined as the simplest reaction of the conjunctiva to a stimulus, a red appearance secondary to the vasodilation of the conjunctival vessels of variable intensity. He will graduate using the Efron scale. 0 Normal , 1 Very slight, 2 Mild, 3 Moderate, 4 Severe.
Number of Participants with adverse events [10 days]
he evaluation of adverse events requires a questioning conducted by the principal investigator and the appropriate exploratory techniques for its detection. the number of adverse events per study group will be considered for the analysis

Secondary Outcome Measures

Intraocular pressure (IOP) [10 days]
Tonometry is the objective measure of Intraocular pressure, based primarily on the force required to flatten the cornea, or the degree of corneal indentation produced by a fixed force. Goldman's tonometry is based on the Imbert-Fick principle. the result will be expressed in millimeters of mercury and the comparison between groups will be carried out.
Visual ability (VA) [10 days]
The VA will be evaluated basally, without refractive correction with the Snellen chart. Which will be located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated
Eye comfort index (ICO) [10 days]
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). Similar to the index for ocular surface diseases, the ocular comfort index (ICO) evaluates symptoms. The ICO contains 6 items that focus on the discomfort associated with the ocular surface. Each of these questions has two parts, which inquire separately the frequency and severity of the symptoms. The evaluator will deliver the questionnaire to the subject and allow the subject to answer it calmly without any pressure and / or coercion, will only assist him if he has difficulty understanding any of the questions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy male and female.
Age ≥ 18 years old at screening visit.

Exclusion Criteria:

Any ocular or systemic condition.
Patient with one blind eye.
Visual acuity of 20/40 in any eye.
Use of ocular or systemics medications.
Contraindications or sensitivity to any component of the study treatments.
Contact lens users.
Ocular surgery within the past 3 months..
Women who were not using an effective means of contraception or who were pregnant or nursing.
Participation in any studies of investigational drugs within 90 days previous to the inclusion.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Independent Clinical Research Center	Guadalajara	Jalisco	Mexico	44100

Sponsors and Collaborators

Laboratorios Sophia S.A de C.V.

Investigators

Principal Investigator: José F Alaniz-De La O, MD, Independent Clinical Research Center
Principal Investigator: Laura R Saucedo-Rodíguez, MD, Independent Clinical Research Center
Study Director: Leopoldo M Baiza-Durán, MD, Clinical Research Department. Laboratorios Sophia SA de CV