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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

Page last updated: August 23, 2015

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