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

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ClinicalTrials.gov Identifier: NCT01657240
Recruitment Status : Suspended (Formula Reformulation)
First Posted : August 6, 2012
Last Update Posted : June 5, 2013
Sponsor:
Information provided by (Responsible Party):
Laboratorios Sophia S.A de C.V.

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: PRO-118 Drug: Olopatadine Hydrochloride Phase 3

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2014
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Pinkeye
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. conjunctival hyperemia [ Time Frame: day 21 ]
    Change from Baseline in conjunctival hyperemia after 21 days of treatment


Secondary Outcome Measures :
  1. epiphora [ Time Frame: day 21 ]
    Change from Baseline in epiphora after 21 days of treatment


Other Outcome Measures:
  1. green lissamine dye [ Time Frame: day 21 ]
    Number of patients with normal green lissamine dye

  2. fluorescein dye [ Time Frame: day 21 ]
    Number of patients with normal fluorescein dye


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier: NCT01657240     History of Changes
Other Study ID Numbers: SOPH118-0112/III
First Posted: August 6, 2012    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Olopatadine Hydrochloride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action