Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension

• Status: Completed
• Trial end date: 2020-11-06
• Target enrollment: 0
• Participant gender: All

Summary

The study is intended to test the effectiveness and safety of Netarsudil / Latanoprost 0.02% / 0.005% Ophthalmic Solution, relative to GANFORT® for lowering of intraocular pressure (IOP) in patients with elevated intraocular pressure

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aerie Pharmaceuticals
• Treatments: Bimatoprost; Cloprostenol; Latanoprost; Ophthalmic Solutions; Pharmaceutical Solutions; Timolol

Criteria

Inclusion Criteria:

1. Must be 18 years or older

2. Diagnosis of Open Angle Glaucoma or Ocular Hypertension

3. Participants insufficiently controlled and/or considered in need for combination therapy

4. Medicated intraocular pressure (IOP) greater than or equal to 17 mmHg and less than 28 mmHg in both eyes at screening visit

5. Unmedicated (post-washout) IOP greater than 20mmHg in at least one eye and less than 36mmHg in both eyes at two qualification visits. At 2nd qualification visit to have IOP greater than 17mmHg in at least one eye and less than 36mmHg in both eyes. If only one eye qualifies at 2nd qualification visit it MUST be the same eye qualified on the 1st visit (this will be known as the study eye).

6. Best corrected visual acuity +1.0 logMAR or better

7. Be willing and able to give informed consent and follow instructions

8. Women must be either of non-child bearing potential, or women with child bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study

9. Women of child bearing potential must have a negative urine pregnancy test within 7 days of first dose of study treatment and agree to use highly effective contraception from time of randomization and for 3 months after last dose of study medication

10. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from time of randomization and for 3 months following the last dose of study medication

11. In France, a subject will be eligible for inclusion in this study only if either affiliated to or as a beneficiary of a social security number

Exclusion Criteria:

Ophthalmic

1. Clinically significant ocular disease which might interfere with interpretation of the study results, including subjects with glaucomatous damage so severe that washout of ocular hypotensive medication for four weeks or longer would not be judged as safe

2. Pseudoexfoliation or pigment dispersion glaucoma, history of narrow angles or angle closure glaucoma. Previous laser peripheral iridotomy is not permitted

3. IOP (NOTE - fixed dose combinations, for the purpose of this exclusion criterion count as one medication); however subjects currently taking 2 fixed dose combination products are excluded.

4. Treatment-naïve subjects

5. Prior treatment with GANFORT® topical eye drops, where subjects IOP did not achieve target IOP and was considered a failure or an insufficient response. Subjects currently (prior to screening visit) being treated with GANFORT® are excluded from the study.

6. Known hypersensitivity to any component of the investigational formulations to be used

7. Previous glaucoma intra ocular surgery

8. Refractive surgery in either eye

9. Ocular trauma within 6 months prior to screening, or ocular surgery or non- refractive laser treatment within 3 months prior to screening

10. Recent or current evidence of ocular infection or inflammation in either eye.

11. Use of ocular medication in either eye within 30 days of screening and throughout the study with the exception of permitted ocular medication (which must be the same medication for 30 days prior to screening) as prescribed by the investigator

12. Mean central corneal thickness greater than 620μm at screening

13. Any abnormality preventing reliable Goldmann applanation tonometry of either eye

Systemic

14. Clinically significant abnormalities in laboratory tests at screening

15. Known hypersensitivity or contraindication to GANFORT® and to β-adrenoceptor antagonists

16. Clinically significant systemic disease which might interfere with the study

17. Participation in any investigational study within 30 days prior to screening

18. Systemic medication (including corticosteroids) that could have a substantial effect on IOP which HAVE NOT been maintained at a consistent dose and regime within 30 days prior to screening, and are anticipated to change in dose and/or regime during the study

19. Use of topical steroids containing medications on the face or in or around the eyes will exclude the subject

20. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable and highly effective form of birth control

21. Vulnerable subjects such as minors, adults under legal protection or unable to express their consent, persons deprived of liberty or persons subject to psychiatric care