Study to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution Versus Vehicle in Patients With Glaucoma

Exclusion Criteria

• •1. Participant has another optic nerve or retinal degenerative disease or co-morbidity causing significant vision loss, irrespective of whether it is currently treated or untreated, that could limit the possibility of visual recovery.
• •2. Participant is blind in one eye.
• •3. Participant has a requirement of acyclovir and/or related products during study duration. 4- Participant has evidence of corneal opacification or lack of optical clarity.
• •4. Participant has evidence of corneal opacification or lack of optical clarity.
• •5. Participant has undergone lens removal in the last 3 months, with or without intra-ocular lens implantation, or has undergone intra-ocular lens replacement within 3 months, or has undergone any other ocular surgery within 9 months prior to initiation of study drug.
• •6. Participant is receiving systemic steroids or other immunosuppressive medications.
• •7. Participant is currently participating in or has within the last 3 months participated in any other clinical trial of a non-clinically approved drug by ocular or systemic administration.
• •8. Participant has uveitis or other ocular inflammatory disease.
• •9. Participant has diabetic macular edema.
• •10. Participant has a history of ocular herpes zoster.
• •11. Participant is on chemotherapy.
• •12. Participant has a history of malignancy, not counting basal cell carcinomas, UNLESS it was treated successfully 2 years prior to inclusion in the trial.
• •13. Known hypersensitivity to one of the components of the study or procedural medications.
• •14. History of drug, medication or alcohol abuse or addiction.
• •15. Females of childbearing potential (those who are not surgically sterilized or post- menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions:
• •1. are currently pregnant or,
• •2. have a positive result on the urine pregnancy test at the Screening/Baseline Visit or,
• •3. intend to become pregnant during the study treatment period or,
• •4. are breast-feeding or,
• •5. not willing to use highly effective birth control measures, such as: Hormonal contraceptives - oral, implanted, transdermal, or injected and/or mechanical barrier methods - spermicide in conjunction with a barrier such as a condom or diaphragm or IUD during the entire course of and 30 days after the study treatment periods.