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

Purpose

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.

Condition	Intervention	Phase
Allergic Conjunctivitis	Drug: PRO-118 Drug: Olopatadine Hydrochloride	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Phase 3 Clinical Trial to Evaluate the Clinical Efficacy of PRO-118 Compared With Olopatadine Hydrochloride Ophthalmic Solution in Allergic Conjunctivitis

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye

Drug Information available for: Olopatadine Olopatadine hydrochloride

U.S. FDA Resources

Further study details as provided by Laboratorios Sophia S.A de C.V.:

Primary Outcome Measures:

conjunctival hyperemia [ Time Frame: day 21 ] [ Designated as safety issue: No ]
Change from Baseline in conjunctival hyperemia after 21 days of treatment

Secondary Outcome Measures:

epiphora [ Time Frame: day 21 ] [ Designated as safety issue: No ]
Change from Baseline in epiphora after 21 days of treatment

Other Outcome Measures:

green lissamine dye [ Time Frame: day 21 ] [ Designated as safety issue: Yes ]
Number of patients with normal green lissamine dye
fluorescein dye [ Time Frame: day 21 ] [ Designated as safety issue: Yes ]
Number of patients with normal fluorescein dye


Estimated Enrollment:	300
Study Start Date:	November 2014
Estimated Study Completion Date:	May 2015
Estimated Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PRO-118 pro-118 ophthalmic solution, instill one drop in each eye once a day for 21 days	Drug: PRO-118 instill one drop in each eye once a day for 21 days Other Name: PRO-118 ophthalmic solution
Active Comparator: Olopatadine Hydrochloride Olopatadine Hydrochloride ophthalmic solution 2%, instill one drop in each eye once a day for 21 days	Drug: Olopatadine Hydrochloride instill one drop in each eye once a day for 21 days Other Name: Olopatadine Hydrochloride ophthalmic solution

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


Ages Eligible for Study:	6 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

No publications provided


Responsible Party:	Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier:	NCT01657240 History of Changes
Other Study ID Numbers:	SOPH118-0112/III
Study First Received:	July 19, 2012
Last Updated:	June 3, 2013
Health Authority:	Mexico: Federal Commission for Sanitary Risks Protection

Additional relevant MeSH terms:


Conjunctivitis Conjunctivitis, Allergic Conjunctival Diseases Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Olopatadine Ophthalmic Solutions Pharmaceutical Solutions Analgesics Analgesics, Non-Narcotic Anti-Allergic Agents Anti-Inflammatory Agents	Anti-Inflammatory Agents, Non-Steroidal Antirheumatic Agents Central Nervous System Agents Histamine Agents Histamine Antagonists Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015