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

• ClinicalTrials.gov Identifier: NCT02804191
• Recruitment Status: Completed
• First Posted: June 17, 2016
• Last Update Posted: February 25, 2021
• Sponsor: Ocuwize LTD
• Information provided by (Responsible Party): Ocuwize LTD

Study Description

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

Condition or disease	Intervention/treatment	Phase
Conjunctivochalasis	Drug: LO2A; Drug: Saline	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: July 2016
• Actual Primary Completion Date: June 2019
• Actual Study Completion Date: June 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. The change from baseline in lissamine green conjunctival staining (LGCS) score. [ Time Frame: 3 Months ]

Secondary Outcome Measures :

1. The change in the lid-parallel conjunctival fold (LIPCOF) grade score at 1 and 3 months compared to baseline [ Time Frame: 3 Months ]
2. The change from baseline in LGCS score [ Time Frame: 1 month ]
3. The change in tear-film break up time (TFBUT) compared to baseline at 1 and 3 months [ Time Frame: 3 Months ]
4. The change in ocular surface disease index (OSDI) questionnaire score compared to baseline at 1 and 3 months [ Time Frame: 3 Months ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Israel

Rambam

Haifa, Israel

Hadassah

Jerusalem, Israel

Ichilov Tel Aviv hospital

Tel Aviv, Israel

Sponsors and Collaborators

Ocuwize LTD

Investigators

• Study Director: Or Eisenberg, CPA; Ocuwize Pharma

More Information

• Responsible Party: Ocuwize LTD
• ClinicalTrials.gov Identifier: NCT02804191
• Other Study ID Numbers: WP-LO2A-01
• First Posted: June 17, 2016
• Last Update Posted: February 25, 2021
• Last Verified: September 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Final Data report will be publish when the study will be finalized