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Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension

NCT02801617 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2024-07-05

Study results available
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Summary

Aim: To demonstrate the non-inferiority of the PRO-067 ophthalmic solution manufactured by Laboratorios Sophia S.A. de C.V. versus GAAP Ofteno® ophthalmic solution like hypotensive therapy in subjects with primary open angle glaucoma or ocular hypertension.

Study design: a multicentric, prospective, crossover (2x2), double blind clinical study. Sample size: one hundred patients with primary open angle glaucoma or ocular hypertension. Patients in the period 1: In the first sequence 60 patients will be assigned to receive the ophthalmic solution: GAAP Ofteno ® (latanoprost 0.005%) 1 drop per day (QD) during 30 days and the second sequence 60 patients will be assigned to receive the ophthalmic solution: PRO-067 1 drop QD during 30 days in the same period. Washout period: 21 hours. Patients in the period 2: the pharmacological intervention change to the opposite therapy for 30 days.

Conditions

Interventions

DRUG

PRO-067

1 drop QD during 30 days is a sterile ophthalmic solution formulated by Laboratorios Sophia S.A. de C.V.

DRUG

GAAP Ofteno®

1 drop QD during 30 days Active comparator, reference medication.

Sponsors & Collaborators

  • Laboratorios Sophia S.A de C.V.

    lead INDUSTRY

Principal Investigators

  • Leopoldo Baiza Durán, MD · Laboratorios Sophia S.A de C.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-03-15
Completion
2017-07-19

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02801617 on ClinicalTrials.gov