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

NCT03698045 | Withdrawn Phase 1 DMC

• 2 other identifiers: SOPH143-0212/IPRO-143
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Conjunctivitis, Bacterial

Keywords

PRO-143; Topical antibiotic; Ophthalmic antibiotic; External bacterial infections

Outcome Measures

Primary Outcomes (2)

• Conjunctival bulbar hyperemia

  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.

  10 days

• Number of Participants with adverse events

  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

  10 days

Secondary Outcomes (3)

• Intraocular pressure (IOP)

  10 days

• Visual ability (VA)

  10 days

• Eye comfort index (ICO)

  10 days

Study Arms (1)

PRO-143 Ophthalmic Solution

EXPERIMENTAL

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

Drug: PRO-143 Ophthalmic Solution

Interventions

PRO-143 Ophthalmic Solution DRUG

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

Also known as: PRO-143

PRO-143 Ophthalmic Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorios Sophia S.A de C.V.: lead

Study Sites (1)

Independent Clinical Research Center

Guadalajara, Jalisco, 44100, Mexico

Location

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Interventions

apolipoprotein A-I Giessen

Condition Hierarchy (Ancestors)

Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Study Officials

• José F Alaniz-De La O, MD

  Independent Clinical Research Center

  PRINCIPAL INVESTIGATOR

• Laura R Saucedo-Rodíguez, MD

  Independent Clinical Research Center

  PRINCIPAL INVESTIGATOR

• Leopoldo M Baiza-Durán, MD

  Clinical Research Department. Laboratorios Sophia SA de CV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2012
• First Posted: October 5, 2018
• Study Start: November 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: October 10, 2018

Record last verified: 2018-10

Locations

ME (1)