A prospective, double-masked, randomized, multicenter, active-controlled,parallel-group, 6-month study assessing the safety and ocular hypotensiveefficacy of PG324 Ophthalmic Solution compared to GANFORT®(bimatoprost 0.03% / timolol 0.5% Opthalmic Solution) in subjects withelevated intraocular pressure (MERCURY 3)

Phase 1

Conditions: open angle glaucoma (OAG) or ocular hypertension (OHT)
MedDRA version: 20.1Level: LLTClassification code 10043273Term: Tension ocular increasedSystem Organ Class: 100000004848
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2015-001528-41-IT

Lead Sponsor: AERIE PHARMACEUTICALS IRELAND LTD.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 440

Inclusion Criteria

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 OAG or OHT in both eyes (OAG in one eye and OHT in the fellow eye is acceptable)
3. Subjects insufficiently controlled and/or subjects considered in need for combination therapy by the investigators
4. Medicated intraocular pressure = 17mmHg in at least one eye and < 28mmHg in both eyes at the screening
5. Unmedicated (post-washout) IOP > 20mmHg in at least one eye and < 36mmHg in both eyes at 2 qualification visits at 08:00 hour, 2-7 days apart. At the second qualification visit, have IOP > 17mmHg in at least one eye and < 36mmHg in both eyes at 10:00 and 16:00 hours.
Note: For purposes of determining eligibility of subjects to be enrolled the non–integral IOP mean number will be used. Any non-integral mean IOP number should not be rounded. If only one eye qualifies at the second qualification visit it MUST be the same eye that qualified on the first visit and this will be the
study eye for the duration of the study.
6. Best corrected visual acuity +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200 or better Snellen visual acuity in each eye)
7. Be able and willing to give signed informed consent and follow study 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 during the study and for 3 months after the 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 form of contraception from time of randomization and for 3months 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 157
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 279

Exclusion Criteria

Ophthalmic:
1. Clinically significant ocular disease which might interfere with interpretation of the study efficacy endpoints or with safety assessments,including subjects with glaucomatous damage so severe that washout of ocular hypotensive medications for 4 weeks or longer if needed is not judged safe as it would put the subject at risk for further vision loss.
2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable
3.Intraocular pressure = 36mmHg (unmedicated) in either eye, or use of more than two ocular hypotensive medications within 30 days of screening. Note: fixed dose combination medications, 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 the subjects IOP did not achieve the target IOP
and was considered either a therapeutic failure or to have insufficient response. Subjects currently
being treated with GANFORT® are excluded from the study.
6. Known hypersensitivity to any component of the investigational formulations to be used or to fluorescein
7. Previous glaucoma intraocular surgery, including SLT or ALT in either eye.
8. Refractive surgery in either eye
9. Ocular trauma within the six months prior to screening, or ocular surgery or non-refractive laser treatment within the three months prior to screening
10. Recent or current evidence of ocular infection or inflammation in either eye. Current evidence of clinically significant blepharitis, conjunctivitis, keratitis, current evidence or history of herpes simplex or zoster keratitis in either eye at screening
11. Use of ocular medication in either eye of any kind within 30 days of screening and throughout the study, with the exception of a) ocular hypotensive medications which must have been the same medication for 30 days prior to screening, b) lid scrubs, c) lubricating drops for dry eye 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 ß-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 corticosteroid containing drugs 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 regimen during the study.
19. Use of topical steroid 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. An adult woman is considered to be of
childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization.
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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method