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

NCT01871077 | Completed Phase 1 Results DMC

• 1 other identifier: SOPH156-0612/I
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Visual Acuity (VA)

  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

  11 days

Secondary Outcomes (3)

• Intraocular Pressure (IOP)

  11 days

• Number of Eyes With Epithelial Defects

  11 days

• Number of Cases With Adverse Events

  11 days

Study Arms (1)

PRO-156

EXPERIMENTAL

Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.

Drug: PRO-156

Interventions

PRO-156 DRUG

Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.

Also known as: Ketorolac

PRO-156

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Interventions

Ketorolac

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: PhD. Ricardo Llamas
• Organization: Laboratorios Sophia

drricardollamas@gmail.com

+52 (33) 3001 4200

Study Officials

• Mauricio Casillas, MD

  Independent Clinical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: June 4, 2013
• First Posted: June 6, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 25, 2019
• Results First Posted: October 25, 2019

Record last verified: 2019-10