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Evaluate the Efficacy and Safety of LO2A Eye Drops for Symptomatic Improvement of Dry Eye in Patients With Sjögren's Syndrome

Primary Purpose

Dry Eye Due to Sjögren's Syndrome

Status

Completed

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

LO2A eye drops

Systane Ultra UD

About this trial

This is an interventional treatment trial for Dry Eye Due to Sjögren's Syndrome

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female of any race and ≥ 18 years of age.
Willing and able to provide voluntary written informed consent.
Primary or secondary Sjögren's syndrome according to the American- European Consensus Classification Criteria (2002).
Females of childbearing potential must agree to use effective contraception consistently throughout the study (such as hormonal contraception or two forms of barrier contraception) and have a negative urine pregnancy test at screening.
Willing and able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

Subject has concurrent, uncontrolled medical condition, or psychiatric illness which could place him/her at unacceptable risk.
Subjects with pterygium.
Subjects with active, allergic keratoconjunctivitis, or conjunctivitis of infectious origin.
Subjects with blepharitis requiring treatment.
Subjects with a history of surgery affecting the eye surface, as well as eye injuries within 3 months of screening.
Subjects currently using any topical ophthalmic treatment (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial.
Female subjects who are pregnant or breast-feeding, or plan to become pregnant during the study.
Subjects that have started or changed the dose of chronic systemic medication within 7 days of Visit 1.
Known hypersensitivity to sodium hyaluronate or any LO2A excipients (glycerol and Carbomer 981) or any of the components in Systane Ultra UD.
Active abuse of alcohol or drugs.
Any condition, which in the opinion of the Investigator, would place the patient at an unacceptable risk if participating in the study protocol.

Sites / Locations

HaEmek MC
Rambam
Rabin MC
Kaplan MC
Ichilov medical center Tel Aviv

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LO2A

Systane Ultra UD

Arm Description

1 drop of sodium hyaluronate instilled into each eye 4 times daily

1 drop of Systane Ultra UD instilled into each eye 4 times daily

Outcomes

Primary Outcome Measures

Change in corneal / conjunctival staining score using the National Eye Institute/Industry(NEI) Industry Grading System

NEI/Industry Workshop Conjunctival Staining Grading System. Devitalized epithelial cells of the bulbar conjunctiva are stained with lissamine green and can graded across six zones The scores for each zone (0-3) are summed to obtain an overall score for each eye (0-18.( The higher the results, the more severe the dryness of the eye.

Secondary Outcome Measures

Change in Ocular Surface Disease Index (OSDI) questionnaire score.

The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.

Change in corneal / conjunctival staining score using the National Eye Institute/Industry(NEI) Industry Grading System

Full Information

NCT ID

NCT03319420

First Posted

October 19, 2017

Last Updated

February 24, 2021

Sponsor

Ocuwize LTD

1. Study Identification

Unique Protocol Identification Number

NCT03319420

Brief Title

Evaluate the Efficacy and Safety of LO2A Eye Drops for Symptomatic Improvement of Dry Eye in Patients With Sjögren's Syndrome

Official Title

A Randomized, Double-Masked, Comparative Study Versus Systane Ultra UD, to Evaluate the Efficacy and Safety of LO2A Eye Drops for Symptomatic Improvement of Dry Eye in Patients With Sjögren's Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

March 29, 2018 (Actual)

Primary Completion Date

January 1, 2021 (Actual)

Study Completion Date

January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ocuwize LTD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Dry eye complaints occur in 5.5 to 33.7% of the population, and are ranked as the most frequent symptoms of patients visiting ophthalmologists. Dry eye syndrome is caused by the reduced production and/or improper quality of the tear film. One of the causes of reduced tear production is Sjögren's syndrome. Sjögren's is estimated to affect up to 4 million patients in the US alone. It affects mostly middle aged women (40-50 years of age) with a female to male prevalence ratio of 9:1. The current study seeks to evaluate the safety and efficacy of LO2A ophthalmic solution in the symptomatic treatment of dry eye in patients with Sjögren's syndrome. This study will be conducted in compliance with the protocol, GCP,and applicable regulatory requirements.

Detailed Description

This is a randomized, double-masked, comparative study versus Systane ultra UD, to evaluate the efficacy and safety of LO2A eye drops for symptomatic improvement of dry eye in Patients with Sjögren's syndrome. Eligible patients will be randomly assigned in a 1:1 ratio to one of two treatment groups, LO2A or Systane ultra UD, respectively. The study will consist of a screening period of up to two weeks and a 3-month double blind treatment period (topical application of eye drops four times daily) Up to 60 subjects are planned to be recruited to this study, randomized to one of two treatment arms using a 1:1 active (LO2A) to Systane ultra UD ratio.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Due to Sjögren's Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

A randomized, double-Masked, comparative study

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Investigator staff involved in the dispensation of study treatments and treatment compliance checks will not be involved in data collection - doublemasked treatment design.

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LO2A

Arm Type

Experimental

Arm Description

1 drop of sodium hyaluronate instilled into each eye 4 times daily

Arm Title

Systane Ultra UD

Arm Type

Active Comparator

Arm Description

1 drop of Systane Ultra UD instilled into each eye 4 times daily

Intervention Type

Drug

Intervention Name(s)

LO2A eye drops

Intervention Description

Sodium hyaluronate

Intervention Type

Drug

Intervention Name(s)

Systane Ultra UD

Intervention Description

Active Ingredients; Polyethylene Glycol Propylene Glycol

Primary Outcome Measure Information:

Title

Change in corneal / conjunctival staining score using the National Eye Institute/Industry(NEI) Industry Grading System

Description

Time Frame

3 months form the basline

Secondary Outcome Measure Information:

Title

Change in Ocular Surface Disease Index (OSDI) questionnaire score.

Description

Time Frame

1 and 3 months from the basline visit

Title

Change in corneal / conjunctival staining score using the National Eye Institute/Industry(NEI) Industry Grading System

Description

Time Frame

After one month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female of any race and ≥ 18 years of age. Willing and able to provide voluntary written informed consent. Primary or secondary Sjögren's syndrome according to the American- European Consensus Classification Criteria (2002). Females of childbearing potential must agree to use effective contraception consistently throughout the study (such as hormonal contraception or two forms of barrier contraception) and have a negative urine pregnancy test at screening. Willing and able to adhere to the study visit schedule and other protocol requirements. Exclusion Criteria: Subject has concurrent, uncontrolled medical condition, or psychiatric illness which could place him/her at unacceptable risk. Subjects with pterygium. Subjects with active, allergic keratoconjunctivitis, or conjunctivitis of infectious origin. Subjects with blepharitis requiring treatment. Subjects with a history of surgery affecting the eye surface, as well as eye injuries within 3 months of screening. Subjects currently using any topical ophthalmic treatment (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial. Female subjects who are pregnant or breast-feeding, or plan to become pregnant during the study. Subjects that have started or changed the dose of chronic systemic medication within 7 days of Visit 1. Known hypersensitivity to sodium hyaluronate or any LO2A excipients (glycerol and Carbomer 981) or any of the components in Systane Ultra UD. Active abuse of alcohol or drugs. Any condition, which in the opinion of the Investigator, would place the patient at an unacceptable risk if participating in the study protocol.

Facility Information:

Facility Name

HaEmek MC

City

Afula

Country

Israel

Facility Name

Rambam

City

Haifa

Country

Israel

Facility Name

Rabin MC

City

Petah tikva

Country

Israel

Facility Name

Kaplan MC

City

Reẖovot

Country

Israel

Facility Name

Ichilov medical center Tel Aviv

City

Tel Aviv

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluate the Efficacy and Safety of LO2A Eye Drops for Symptomatic Improvement of Dry Eye in Patients With Sjögren's Syndrome

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