Clinical Efficacy of PRO-118 Compared With Olopatadine Hydrochloride Ophthalmic Solution in Allergic Conjunctivitis

October 1, 2018 updated by: Laboratorios Sophia S.A de C.V.

Phase 3 Clinical Trial to Evaluate the Clinical Efficacy of PRO-118 Compared With Olopatadine Hydrochloride Ophthalmic Solution in Allergic Conjunctivitis

The purpose of this study is to evaluate the clinical efficacy of the ophthalmic solution PRO-118 compared with olopatadine hydrochloride ophthalmic solution in allergic conjunctivitis.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Allergic conjunctivitis is inflammation of the tissue lining the eyelids (conjunctiva) due to a reaction from allergy-causing substances. The main aim in allergic conjunctivitis is to improve the quality of life in these patients. Antihistaminic medication is commonly used to treat allergic conjunctivitis symptoms. The aim of the study is to compare the clinical efficacy of two ophthalmic solutions containing each one an antihistaminic drug.

A phase III randomized double-blind clinical trial will be conducted to evaluate efficacy of the ophthalmic solution PRO-118 compared with olopatadine hydrochloride ophthalmic solution in allergic conjunctivitis. Patients will be randomized to receive one of the treatments for 21 days. Efficacy endpoints will be measured at baseline and at 21 days after treatment.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provide informed consent
  • Allergic conjunctivitis diagnosis
  • Both genders
  • Age between 6 and 60 years
  • Patients with no treatment 2 years prior to study inclusion

Exclusion Criteria:

  • Patients with one blind eye
  • Visual acuity < 20/40 in any eye
  • Patients with any active ocular disease that would interfere with study interpretation
  • Patients in treatment with any medication that could interfere with the study, contraindication of any medication used in the protocol
  • Patients with: diabetes mellitus, rheumatoid arthritis, hypertension, or any type of cancer
  • Patients with history of hypersensitivity or contraindication for any drug used in the study
  • Patients receiving systemic or topical treatment based on antihistamines, corticosteroids or immunomodulators
  • Pregnant patients, at risk of pregnancy or breastfeeding
  • Patients without birth control treatment
  • Patients who had participated in any clinical trial in the last 90 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRO-118
pro-118 ophthalmic solution, instill one drop in each eye once a day for 21 days
Drug: PRO-118
instill one drop in each eye once a day for 21 days
Other Names:
  • PRO-118 ophthalmic solution
Active Comparator: Olopatadine Hydrochloride
Olopatadine Hydrochloride ophthalmic solution 2%, instill one drop in each eye once a day for 21 days
Drug: Olopatadine Hydrochloride
instill one drop in each eye once a day for 21 days
Other Names:
  • Olopatadine Hydrochloride ophthalmic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
conjunctival hyperemia
Time Frame: day 21
Change from Baseline in conjunctival hyperemia after 21 days of treatment
day 21

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
epiphora
Time Frame: day 21
Change from Baseline in epiphora after 21 days of treatment
day 21

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
green lissamine dye
Time Frame: day 21
Number of patients with normal green lissamine dye
day 21
fluorescein dye
Time Frame: day 21
Number of patients with normal fluorescein dye
day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Sophia S.A de C.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

July 19, 2012

First Submitted That Met QC Criteria

August 3, 2012

First Posted (Estimate)

August 6, 2012

Study Record Updates

Last Update Posted (Actual)

October 2, 2018

Last Update Submitted That Met QC Criteria

October 1, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOPH118-0112/III

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Allergic Conjunctivitis

Clinical Trials on PRO-118

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe