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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

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ClinicalTrials.gov Identifier: NCT03319420
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Ocuwize LTD

Tracking Information
First Submitted Date  ICMJE October 19, 2017
First Posted Date  ICMJE October 24, 2017
Last Update Posted Date April 26, 2018
Actual Study Start Date  ICMJE March 29, 2018
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2017)
Change in corneal / conjunctival staining score using the National Eye Institute/Industry(NEI) Industry Grading System [ Time Frame: 3 months form the basline ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 23, 2017)
Change in corneal / conjunctival staining score using the NEI/Industry Grading System [ Time Frame: 3 months ]
Change History Complete list of historical versions of study NCT03319420 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2018)
  • Change in Ocular Surface Disease Index (OSDI) questionnaire score. [ Time Frame: 1 and 3 months from the basline visit ]
    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 [ Time Frame: After one month ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2017)
  • Change in Ocular Surface Disease Index (OSDI) questionnaire score. [ Time Frame: After one the three months ]
  • Change in corneal / conjunctival staining score using the NEI/Industry Grading System [ Time Frame: After one month ]
  • Change in tear production using Schirmer's test. [ Time Frame: After one the three months ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Efficacy and Safety of LO2A Eye Drops for Symptomatic Improvement of Dry Eye in Patients With Sjögren's Syndrome
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A randomized, double-Masked, comparative study
Masking: Triple (Participant, Investigator, Outcomes 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.
Primary Purpose: Treatment
Condition  ICMJE Dry Eye Due to Sjögren's Syndrome
Intervention  ICMJE
  • Drug: LO2A eye drops
    Sodium hyaluronate
  • Drug: Systane Ultra UD
    Active Ingredients; Polyethylene Glycol Propylene Glycol
Study Arms
  • Experimental: LO2A
    1 drop of sodium hyaluronate instilled into each eye 4 times daily
    Intervention: Drug: LO2A eye drops
  • Active Comparator: Systane Ultra UD
    1 drop of Systane Ultra UD instilled into each eye 4 times daily
    Intervention: Drug: Systane Ultra UD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 4, 2018)
60
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2017)
40
Estimated Study Completion Date February 2019
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Sergiu Socea, MD 972 (4) 777-2489 sergiusoc@gmail.com
Contact: Meital Abecasis 972 (4) 777-2489 m_abecassis@rambam.health.gov.il
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03319420
Other Study ID Numbers  ICMJE WP-LO2A-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Ocuwize LTD
Study Sponsor  ICMJE Ocuwize LTD
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ocuwize LTD
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP