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

• Status: Withdrawn
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Sophia S.A de C.V.
• Treatments: Olopatadine Hydrochloride; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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