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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-29

Study Completion Date

2021-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dry Eye Due to Sjögren's Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, double-Masked, comparative study

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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

Study Groups

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LO2A

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

Group Type EXPERIMENTAL

LO2A eye drops

Intervention Type DRUG

Sodium hyaluronate

Systane Ultra UD

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

Group Type ACTIVE_COMPARATOR

Systane Ultra UD

Intervention Type DRUG

Active Ingredients; Polyethylene Glycol Propylene Glycol

Interventions

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LO2A eye drops

Sodium hyaluronate

Intervention Type DRUG

Systane Ultra UD

Active Ingredients; Polyethylene Glycol Propylene Glycol

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No