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

This study has suspended participant recruitment.
(Formula Reformulation)
Sponsor:
Information provided by (Responsible Party):
Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier:
NCT01657240
First received: July 19, 2012
Last updated: June 3, 2013
Last verified: June 2013
  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:


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 November 24, 2014