| 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
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