Clinical Efficacy of PRO-118 Compared With Olopatadine Hydrochloride Ophthalmic Solution in Allergic Conjunctivitis
Information source: Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Conjunctivitis
Intervention: PRO-118 (Drug); Olopatadine Hydrochloride (Drug)
Phase: Phase 3
Status: Suspended
Sponsored by: Laboratorios Sophia S.A de C.V.
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.
Clinical Details
Official title: Phase 3 Clinical Trial to Evaluate the Clinical Efficacy of PRO-118 Compared With Olopatadine Hydrochloride Ophthalmic Solution in Allergic Conjunctivitis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: conjunctival hyperemia
Secondary outcome: epiphora
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.
Eligibility
Minimum age: 6 Years.
Maximum age: 60 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: November 2014
Last updated: June 3, 2013
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