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

Allergic Conjunctivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01657240
• Other study ID #: SOPH118-0112/III
• Status: Withdrawn
• Phase: Phase 3
• Start date: November 2014
• Est. completion date: May 2015

Study information

• Verified date: October 2018
• Source: Laboratorios Sophia S.A de C.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• PRO-118
instill one drop in each eye once a day for 21 days
• Olopatadine Hydrochloride
instill one drop in each eye once a day for 21 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Sophia S.A de C.V.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	green lissamine dye	Number of patients with normal green lissamine dye	day 21
Other	fluorescein dye	Number of patients with normal fluorescein dye	day 21
Primary	conjunctival hyperemia	Change from Baseline in conjunctival hyperemia after 21 days of treatment	day 21
Secondary	epiphora	Change from Baseline in epiphora after 21 days of treatment	day 21