open angle glaucoma (OAG) or ocular hypertension (OHT)
Conditions
Interventions
Product Name: Roclatan
Product Code: PG324
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: Latanoprost
CAS Number: 130209-82-4
Current Sponsor code: PG324
Other descriptive name: LATANOP
Sponsors
Aerie Pharmaceuticals Ireland Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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 > 18mmHg and 20mmHg and 17mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range 472
Exclusion criteria
Exclusion criteria: 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. Prior treatment with GANFORT topical eye drops 6. Known hypersensitivity to any component of the investigational formulations to be used (e.g., benzalkonium chloride etc.) or to fluorescein 7. Previous glaucoma intraocular surgery, including SLT or ALT in either eye 8. Refractive surgery in either eye (e.g., radial keratotomy, PRK, LASIK, corneal cross-linking, keratoplasty) 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 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 12. Mean central corneal thickness greater than 620µm at screening 13. Any abnormality preventing reliable Goldmann applanation tonometry of either eye (e.g., keratoconus) Systemic: 14. Clinically significant abnormalities in laboratory tests at screening 15. Known hypersensitivity or contraindication to GANFORT (Appendix 3 Marketed Product Medication Information section 3) and 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; cardiac failure, cardiac shock and severe diabetes). 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate: • The ocular hypotensive efficacy of PG324 Ophthalmic Solution relative to GANFORT® Ophthalmic solution over a 3-month period • The ocular and systemic safety of PG324 Ophthalmic Solution relative to GANFORT® Ophthalmic solution over a 6-month period ;Secondary Objective: To evaluate: • 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® • 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: • 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy outcomes will be comparison of PG324 Ophthalmic Solution relative to GANFORT® for: • Mean diurnal IOP within a treatment group at each post-treatment visit • Mean change from diurnally adjusted baseline IOP at each post-treatment time point • Mean change from baseline in diurnal IOP at each post-treatment visit • Mean percent change from diurnally adjusted baseline IOP at each post-treatment time point • Mean percent change from baseline in diurnal IOP at each post-treatment visit • Mean percent change from diurnally adjusted baseline IOP at each post-treatment time point • Mean percent change from baseline in diurnal IOP at each post-treatment visit • Percentages of subjects achieving pre-specified mean, mean change, and percent mean change in diurnal IOP levels Other secondary efficacy analyses may be carried out as described in the study Statistical Analysis Plan. ;Timepoint(s) of evaluation of this end point: end of last dose treatment and at the end of clinical trial | — |
Countries
Austria, Belgium, France, Germany, Hungary, Italy, Latvia, Poland, Spain, United Kingdom
Contacts
Public ContactFinbar O’Neill
Aerie Pharmaceuticals Ireland Ltd.
Outcome results
None listed