Stop Retinal Ganglion Cell Dysfunction Study

The PERG is recorded from small metallic buttons taped on the skin similarly to an
electrocardiogram, with the difference that the electrodes are around the eyes.

The only physical contact you will experience is a gentle cleaning of the skin with an
alcohol prep pad. During the test you must look with both eyes at a Television (TV) display
for about 3 minutes. During the follow up period you may be asked to take one more PERG test
lying down in a bed.

This will cause a momentary increase of your eye pressure similar to the one that occurs
during your normal sleep. This may help to understand whether or not your optic nerve
functions normally when the pressure in your eye increases. For OCT evaluation, the pupil has
to be dilated with drops as you did before for your eye exam. You have to briefly look at a
mark inside the instrument one eye at a time.

PERG and OCT will be performed during the same day of your visit with the eye doctor. If you
have already done these tests in the past, as part of another study or as part of your
standard treatment, the results of these tests will be obtained from your record, and be
included in this study.

If you are a participant in the Observation Group, you will be monitored with PERG, OCT, and
standard clinical examinations every six months until close of study. If you are a
participant in the Medication Group you will be also treated with eye drop medicines.

RISKS:

There are certain risks and discomforts that may be associated with this research. You should
be aware that you are at risk of developing glaucoma whether you participate in the study or
not. It is not known whether the risk of developing glaucoma is reduced by eye drops to lower
eye pressure; the study will attempt to answer this question.

For the PERG, the only significant risk to you is a small chance of a rash to the cleansing
agent for skin electrodes, which should go away without treatment. For OCT, there is a rare
risk to you of an allergic reaction to the drops used to dilate your pupils. The risk is even
lower if you did not have any reaction during your previous eye exams. In case of an allergic
reaction, your eye doctor will immediately treat it. If you had previous problems with pupil
dilation, you may wish to speak to your eye doctor about the option of doing this additional
test.

Inclusion Criteria:

1. Age 18 to 85 years, inclusive

2. Refractive errors within -5 to +3 diopters

3. Best corrected visual acuity (BCVA) better than or equal to 20/30 (Snellen)

4. Normal standard automated perimetry (SAP) according to the Ocular Hypertension
Treatment Study (OHTS) criteria15 (reliability < 15% on all indices, normality > 5% on
all global indices in two consecutive sessions 6 months apart)

5. Minimum untreated Intraocular pressure IOP of 15 mm Hg

6. Glaucoma Suspect Status defined as one or more of the following:

- Glaucomatous optic disc appearance (vertical cup-to-disc ratio [C/D] ≥0.5

- Cup disc ratio asymmetry ≥0.2

- Localized thinning of the disc

- Presence or history of splinter disc hemorrhage

- Moderately increased IOP (>21 to <28 mm Hg).

- Family history of vision loss for glaucoma

Exclusion Criteria:

1. Age-related macular degeneration

2. Diabetes

3. Parkinson's disease

4. Multiple sclerosis

5. Unwilling or unable to give consent, unwilling to accept randomization, or unable to
return for scheduled protocol visits.

6. Pregnant or nursing women.

7. Currently using prescribed pressure lowering medicines and unwilling to be withdrawn
from them.

8. An OHTS risk score high enough in the judgment of the ophthalmologist or optometrist
managing the patient to recommend pressure lowering medicine to the patient and not
randomization.

9. An OCT abnormal enough in a pattern consistent with glaucoma.