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

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

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

Study Overview

• Status: Completed
• Conditions: Conjunctivochalasis
• Intervention / Treatment: Drug: LO2A; Drug: Saline

Detailed Description

Phase 2, randomized, placebo-controlled, parallel group, study in up to 62 adult patients with moderate to severe CCh. Eligible patients will be randomly assigned in a 1:1 ratio to one of two treatment groups, LO2A or placebo, stratified by LIPCOF grade at baseline.

This study with 4 visits, will consist of a screening period of up to 2 weeks and a 3-month treatment period (topical, OU, QID application of eye drops).

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam
  • Jerusalem, Israel
    • Hadassah
  • Tel Aviv, Israel
    • Ichilov Tel Aviv hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female of any race and ≥ 18 years of age.
2. Willing and able to provide voluntary written informed consent.

3. Moderate to severe conjunctivochalasis defined by:

   • LIPCOF score ≥ 2; and
   • Lissamine green conjunctival staining score ≥ 5 according to National Eye Institute/Industry Workshop report.
4. Willing and able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

1. 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.
2. Subjects with pterygium.
3. Subjects with active, allergic keratoconjunctivitis, or conjunctivitis of infectious origin.
4. Subjects with blepharitis requiring treatment.
5. Subjects with a history of surgery affecting the eye surface, as well as eye injuries within 3 months of screening.
6. 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.

7. 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.
8. Known hypersensitivity to sodium hyaluronate or any LO2A excipients (glycerol and Carbomer 981).
9. Active abuse of alcohol or drugs.
10. Any condition, which in the opinion of the Investigator, would place the patient at an unacceptable risk if participating in the study protocol.
11. Participation in a clinical trial of an investigational (unapproved) drug or device within 1 month prior to screening or scheduled to receive another investigational drug or device during this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LO2A; Sodium Hyaluronate	Drug: LO2A; eye drop solution.
Placebo Comparator: Placebo-Controlled; Saline.	Drug: Saline; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change from baseline in lissamine green conjunctival staining (LGCS) score.	3 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ocuwize LTD
• Investigators: Study Director: Or Eisenberg, CPA, Ocuwize Pharma

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: June 6, 2016
• First Submitted That Met QC Criteria: June 14, 2016
• First Posted (Estimate): June 17, 2016

Study Record Updates

• Last Update Posted (Actual): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: WP-LO2A-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Final Data report will be publish when the study will be finalized

Drug and device information, study documents

• 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