Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients With Moderate to Severe Conjunctivochalasis

NCT02804191 | Completed Phase 2

• 1 other identifier: WP-LO2A-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 3

Brief Summary

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients with Moderate to Severe Conjunctivochalasis

Conditions

Conjunctivochalasis

Outcome Measures

Primary Outcomes (1)

• The change from baseline in lissamine green conjunctival staining (LGCS) score.

  3 Months

Secondary Outcomes (4)

• The change in the lid-parallel conjunctival fold (LIPCOF) grade score at 1 and 3 months compared to baseline

  3 Months

• The change from baseline in LGCS score

  1 month

• The change in tear-film break up time (TFBUT) compared to baseline at 1 and 3 months

  3 Months

• The change in ocular surface disease index (OSDI) questionnaire score compared to baseline at 1 and 3 months

  3 Months

Study Arms (2)

LO2A

EXPERIMENTAL

Sodium Hyaluronate

Drug: LO2A

Placebo-Controlled

PLACEBO COMPARATOR

Saline.

Drug: Saline

Interventions

LO2A DRUG

eye drop solution.

LO2A

Saline DRUG

Placebo

Placebo-Controlled

Eligibility Criteria

• Age: 18 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.
• Moderate to severe conjunctivochalasis defined by:
• LIPCOF score ≥ 2; and
• Lissamine green conjunctival staining score ≥ 5 according to National Eye Institute/Industry Workshop report.
• 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, including, but not limited to:
• Subject has been diagnosed or treated for another malignancy within 3 years of screening, except in situ malignancy, or low-risk prostate, skin or cervix cancer after curative therapy.
• A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications.
• 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.
• Subjects who have used any of the following medications or treatments:
• LASIK or PRK surgery within 12 months of Visit 1.
• Use of contact lenses within 7 days of Visit 1.
• Punctal plug insertion within 30 days of Visit 1.
• Use of topical or systemic cyclosporine within 30 days of Visit 1.
• Use of medications known to cause ocular drying (e.g. antihistamines, sleep aids, etc.), unless at a stable dose, within 30 days of Visit 1.
• Known hypersensitivity to sodium hyaluronate or any LO2A excipients (glycerol and Carbomer 981).

Sponsors & Collaborators

• Ocuwize LTD: lead

Study Sites (3)

Rambam

Haifa, Israel

Location

Hadassah

Jerusalem, Israel

Location

Ichilov Tel Aviv hospital

Tel Aviv, Israel

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Or Eisenberg, CPA

  Ocuwize Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 17, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: February 25, 2021

Record last verified: 2017-09

Locations

IL (3)