To Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients With Conjunctivochalasis

Conjunctivochalasis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Pilot Study to Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients With Moderate to Severe Conjunctivochalasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02810119
• Other study ID #: WP-LO2A-02
• Status: Completed
• Phase: Phase 2
• First received: June 19, 2016
• Last updated: October 25, 2017
• Start date: November 2016
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: Ocuwize LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Phase 2a, randomized, placebo-controlled, pilot study in up to 21 adult patients with moderate to severe CCh. Eligible patients will be randomly assigned in a 2:1 (active:placebo) ratio to one of two treatment groups, LO2A or placebo.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Conjunctivochalasis

Intervention

Drug:
• LO2A

• Placebo

Locations

Country	Name	City	State
Israel	Barzilai MC	Ashkelon

Sponsors (1)

Lead Sponsor	Collaborator
Ocuwize LTD

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline in lissamine green conjunctival staining (LGCS) score		baseline and 3 months
Secondary	The change in the lid-parallel conjunctival fold (LIPCOF) grade score at 1 and 3 months compared to baseline		baseline, 1 month and 3 months
Secondary	The change from baseline in LGCS score		baseline and 1 month
Secondary	The change in tear-film break up time (TFBUT) compared to baseline at 1 and 3 months		baseline, 1 month and 3 months]
Secondary	The change in ocular surface disease index (OSDI) questionnaire score compared to baseline at 1 and 3 months		baseline, 1 month and 3 months