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

Phase 3

Withdrawn

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Olopatadine Hydrochloride; Drug: PRO-118

• Registration Number: NCT01657240
• Lead Sponsor: Laboratorios Sophia S.A de C.V.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-08-03
• Study First Posted: 2012-08-06
• Study Start: 2014-11
• Primary Completion: 2015-04
• Study Completion: 2015-05
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olopatadine Hydrochloride	Olopatadine Hydrochloride	Olopatadine Hydrochloride ophthalmic solution 2%, instill one drop in each eye once a day for 21 days
PRO-118	PRO-118	pro-118 ophthalmic solution, instill one drop in each eye once a day for 21 days

Primary Outcome Measures

Name	Time	Method
conjunctival hyperemia	day 21	Change from Baseline in conjunctival hyperemia after 21 days of treatment

Secondary Outcome Measures

Name	Time	Method
epiphora	day 21	Change from Baseline in epiphora after 21 days of treatment