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

Laboratorios Sophia

Status and phase: Withdrawn; Phase 3

Conditions: Allergic Conjunctivitis

Treatments: Drug: PRO-118; Drug: Olopatadine Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01657240

SOPH118-0112/III

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 6 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

PRO-118

Experimental group

Description:

pro-118 ophthalmic solution, instill one drop in each eye once a day for 21 days

Treatment:

Drug: PRO-118

Olopatadine Hydrochloride

Active Comparator group

Description:

Olopatadine Hydrochloride ophthalmic solution 2%, instill one drop in each eye once a day for 21 days

Treatment:

Drug: Olopatadine Hydrochloride