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

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).

Inclusion criteria

• 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.

Exclusion criteria

• 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).
• 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.
• 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.