Clinical Efficacy of PRO-118 Compared With Olopatadine Hy... | NCT01657240

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

NCT01657240

Sponsor

Laboratorios Sophia S.A de C.V.

Status

Withdrawn

Last Update Posted

Oct 2, 2018Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Allergic Conjunctivitis

Interventions

PRO-118
Olopatadine Hydrochloride

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Formula Reformulation

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Apr 2015Estimated

Completion Date

May 2015Estimated

First Submitted Date

Jul 19, 2012

First Submission Date that Met QC Criteria

Aug 3, 2012

First Posted Date

Aug 6, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2018

Last Update Posted Date

Oct 2, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PRO-118	Experimental	pro-118 ophthalmic solution, instill one drop in each eye once a day for 21 days	Drug: PRO-118
Olopatadine Hydrochloride	Active Comparator	Olopatadine Hydrochloride ophthalmic solution 2%, instill one drop in each eye once a day for 21 days	Drug: Olopatadine Hydrochloride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PRO-118	Drug	instill one drop in each eye once a day for 21 days	PRO-118

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
conjunctival hyperemia	Change from Baseline in conjunctival hyperemia after 21 days of treatment	day 21

Secondary Outcomes

Measure	Description	Time Frame
epiphora	Change from Baseline in epiphora after 21 days of treatment	day 21

Other Outcomes

Measure	Description	Time Frame
green lissamine dye	Number of patients with normal green lissamine dye	day 21
fluorescein dye	Number of patients with normal fluorescein dye

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003233	Conjunctivitis, Allergic

Ancestor Terms

ID	Term
D003231	Conjunctivitis
D003229	Conjunctival Diseases
D005128	Eye Diseases
D006969	Hypersensitivity, Immediate

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069605	Olopatadine Hydrochloride

Ancestor Terms

ID	Term
D003990	Dibenzoxepins
D006575	Heterocyclic Compounds, 3-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided