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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: PRO-118
* Drug: Olopatadine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRO-118<br>pro-118 ophthalmic solution, instill one drop in each eye once a day for 21 days | Drug: PRO-118<br>* instill one drop in each eye once a day for 21 days<br>* Other names: PRO-118 ophthalmic solution;|
| Active Comparator: Olopatadine Hydrochloride<br>Olopatadine Hydrochloride ophthalmic solution 2%, instill one drop in each eye once a day for 21 days | Drug: Olopatadine Hydrochloride<br>* instill one drop in each eye once a day for 21 days<br>* Other names: Olopatadine Hydrochloride ophthalmic solution;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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