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

NCT03319420 | Completed Phase 4 DMC

• 1 other identifier: WP-LO2A-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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.

Conditions

Dry Eye Due to Sjögren's Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months form the basline

Secondary Outcomes (2)

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

  1 and 3 months from the basline visit

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

  After one month

Study Arms (2)

LO2A

EXPERIMENTAL

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

Drug: LO2A eye drops

Systane Ultra UD

ACTIVE COMPARATOR

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

Drug: Systane Ultra UD

Interventions

LO2A eye drops DRUG

Sodium hyaluronate

LO2A

Systane Ultra UD DRUG

Active Ingredients; Polyethylene Glycol Propylene Glycol

Systane Ultra UD

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ocuwize LTD: lead

Study Sites (5)

HaEmek MC

Afula, Israel

Location

Rambam

Haifa, Israel

Location

Rabin MC

Petah Tikva, Israel

Location

Kaplan MC

Rehovot, Israel

Location

Ichilov medical center Tel Aviv

Tel Aviv, Israel

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator staff involved in the dispensation of study treatments and treatment compliance checks will not be involved in data collection - doublemasked treatment design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, double-Masked, comparative study

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 24, 2017
• Study Start: March 29, 2018
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: February 25, 2021

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (5)