A prospective, double-masked, randomized, multicenter, active-controlled, parallel-group, 6-month study assessing the safety and ocular hypotensive efficacy of PG324 Ophthalmic Solution compared to GANFORT® (bimatoprost 0.03% / timolol 0.5% Opthalmic Solution) in subjects with elevated intraocular pressure (MERCURY 3)
- Conditions
- open angle glaucoma (OAG) or ocular hypertension (OHT)Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2015-001528-41-ES
- Lead Sponsor
- Aerie Pharmaceuticals Ireland Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 430
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 > 18mmHg and < 25mmHg in both eyes at screening visit
5.Unmedicated (post-washout) IOP > 20mmHg 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 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.
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 contraception from time of randomization and for 3months following the last dose of study medication
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 472
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 472
Subjects meeting any of the following criteria during screening or qualification evaluations (e.g., at the time of randomization) will be excluded from entry into the study:
Ophthalmic:
1.Clinically significant ocular disease (e.g. corneal edema, uveitis, or severe keratoconjunctivitis sicca) 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 (i.e., Grade 2 Shaffer (Chan Ry 1981) or less; extreme narrow angle with complete or partial closure). Note: Previous laser peripheral iridotomy is NOT acceptable
3.Intraocular pressure = 36mmHg (unmedicated) in either eye (individuals who are excluded for this criterion are not allowed to attempt requalification), 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
4.Treatment-naïve subjects
5.Known hypersensitivity to any component of the investigational formulations to be used (e.g., benzalkonium chloride etc.) or to fluorescein
6.Previous glaucoma intraocular surgery, including SLT or ALT in either eye
7.Refractive surgery in either eye (e.g., radial keratotomy, PRK, LASIK, corneal cross-linking, keratoplasty)
8.Ocular trauma within the six months prior to screening, or ocular surgery or non-refractive laser treatment within the three months prior to screening
9.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
10.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 be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after, screening), c) lubricating drops for dry eye (which may be used throughout the study) as prescribed by the Investigator
11.Mean central corneal thickness greater than 620µm at screening
12.Any abnormality preventing reliable Goldmann applanation tonometry of either eye (e.g., keratoconus)
Systemic:
13.Clinically significant abnormalities in laboratory tests at screening
14.Known hypersensitivity or contraindication to ß-adrenoceptor antagonists (e.g. Chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure or heart rate; second or third degree heart block or congestive heart failure; severe diabetes)
15.Clinically significant systemic disease which might interfere with the study
16.Participation in any investigational study within 30 days prior to screening
17.Systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study, including any corticosteroid-containing drug regardless of route of administration
18.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 ad
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate:<br>•The ocular hypotensive efficacy of PG324 Ophthalmic Solution relative to GANFORT® Ophthalmic solution over a 3-month period<br>•The ocular and systemic safety of PG324 Ophthalmic Solution relative to GANFORT® Ophthalmic solution over a 6-month period;Secondary Objective: To evaluate:<br>•Change in Self-Administered National Eye Institute ( NEI) Visual Functioning Questionnaire 25 (VFQ 25) score from baseline to study exit for PG324 compared to GANFORT®<br>•Change in self-administered Short Form Health Survey Questionnaire 36 (SF-36 v2) score from baseline to study exit for PG324 compared to GANFORT®;Primary end point(s): The primary efficacy outcome will be comparison of PG324 Ophthalmic Solution relative to GANFORT® for:<br>•Mean IOP within a treatment group at the following time points: 08:00, 10:00, and 16:00 hours at the Week 2, Week 6, and Month 3 study visits;Timepoint(s) of evaluation of this end point: end of last dose treatment and at the end of clinical trial
- Secondary Outcome Measures
Name Time Method