NCT01657240

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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 6 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	PRO-118	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

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-04-01
• Completion: 2015-05-01
• First posted: 2012-08-06
• Last updated: 2018-10-02