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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 March 2021
• Main ID: NCT03319420
• Date of registration: 19/10/2017
• Prospective Registration: Yes
• Primary sponsor: Ocuwize LTD
• Public title: Evaluate the Efficacy and Safety of LO2A Eye Drops for Symptomatic Improvement of Dry Eye in Patients With Sjögren's Syndrome
• Scientific 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
• Date of first enrolment: March 29, 2018
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03319420
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Israel

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 95 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dry Eye Due to Sjögren's Syndrome

Intervention(s)

Drug: LO2A eye drops

Drug: Systane Ultra UD

Primary Outcome(s)

Change in corneal / conjunctival staining score using the National Eye Institute/Industry(NEI) Industry Grading System [Time Frame: 3 months form the basline]

Secondary Outcome(s)

Change in corneal / conjunctival staining score using the National Eye Institute/Industry(NEI) Industry Grading System [Time Frame: After one month]

Change in Ocular Surface Disease Index (OSDI) questionnaire score. [Time Frame: 1 and 3 months from the basline visit]

Secondary ID(s)

WP-LO2A-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors