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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:
Laboratorios Sophia S.A de C.V.
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
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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 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 |
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 ]Change from Baseline in conjunctival hyperemia after 21 days of treatment
Secondary Outcome Measures:
- epiphora [ Time Frame: day 21 ]Change from Baseline in epiphora after 21 days of treatment
Other Outcome Measures:
- green lissamine dye [ Time Frame: day 21 ]Number of patients with normal green lissamine dye
- fluorescein dye [ Time Frame: day 21 ]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 (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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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 |
| Study First Received: | July 19, 2012 |
| Last Updated: | June 3, 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 |
ClinicalTrials.gov processed this record on September 21, 2017