A prospective, double-masked, randomized, multi-center, active-controlled, parallel-group 12-month study assessing the safety and ocular hypotensive efficacy of PG324 Ophthalmic Solution compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in subjects with elevated intraocular pressure.
Principal Investigator: Yao Liu
Coordinator: Chris Smith 608-263-7169
The ocular hypotensive efficacy of PG324 Ophthalmic Solution relative to each of its active components, AR-13324, 0.02% and Latanoprost, 0.005% at 08:00, 10:00, and 16:00 hours at Week 2, Week 6, and Month 3
The ocular and systemic safety of PG324 Ophthalmic Solution during a 12-month treatment period
Subjects have to meet all of the following criteria at screening and qualification visits to enter into the study:
1. Must be 18 years of age or older
2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) in both eyes (OAG in one eye and OHT in the fellow eye is acceptable)
3. Unmedicated (post-washout) IOP > 20 mmHg and < 36 mmHg in one or both eyes at 2 qualification visits at 08:00 hour, 2-7 days apart. At the second qualification visit, have IOP > 17 mmHg and < 36 mmHg in one or both eyes at 10:00 and 16:00 hours. If only one eye qualifies at the second qualification visit, it must be the same eye at all time points as the eye that qualified at the first qualification visit. Note: For purposes of determining eligibility of subjects to be enrolled, any non-integral mean IOP number should not be rounded.
4. Best corrected visual acuity +1.0 logMAR or better by ETDRS chart in each eye (equivalent to 20/200 or better Snellen visual acuity in each eye)
Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure, or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
Previous glaucoma intraocular surgery including SLT or ALT in either eye
Use of more than two ocular hypotensive medications within 30 days of screening. (Note: fixed dose combinations count as one medication). Patient must safely complete washout.
Ocular surgery or non-refractive laser treatment within three months prior to screening.
Ocular trauma in either eye within the six months prior to screening