E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Open-Angle Glaucoma or Ocular Hypertension |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030348 |
E.1.2 | Term | Open angle glaucoma |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030043 |
E.1.2 | Term | Ocular hypertension |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate that the intraocular pressure (IOP) reducing effect of DE-130A (latanoprost 50 µg/ml preservative-free eye drops emulsion) is non-inferior to that of Xalatan® [latanoprost 50 µg/ml Benzalkonium Chloride (BAK)-preserved eye drops solution] in patients with Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT) at Week 12 without using any rescue medication(s). |
|
E.2.2 | Secondary objectives of the trial |
- To compare the effect on improving OSD signs and symptoms between treatment groups over 3 months (Period 1). - To estimate the effect of DE-130A on OSD signs and symptoms improvement up to 15 months (Periods 1 & 2). - To compare the efficacy on IOP reduction between treatment groups over 3 months (Period 1). - To estimate the effect of DE-130A on IOP up to 15 months (Periods 1 & 2). - To estimate the local ocular tolerance and systemic safety of the two treatments over 3 months (Period 1). - To estimate the local ocular tolerance and systemic safety of DE-130A up to 15 months (Periods 1 & 2). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Male or female, 18 years of age or older -Diagnosis of OAG (primary open angle glaucoma, pseudo exfoliative glaucoma, or pigmentary glaucoma), or OHT in eligible eye(s) currently on monotherapy. -Unilateral OAG, or OHT are permissible as long as the physician does not anticipate significant IOP changes to the fellow eye that would require treatment during the duration of the study. -Current treatment with monotherapy for OAG or OHT with a controlled IOP ≤ 18 mmHg in each eye (pre-washout). -Stable visual field. If historical visual fields not available within the last 18 months prior to screening but, at least two OCTs are available including one in the last 6 months and are stable, the patient can be enrolled if a visual field test is also performed at screening and shows no defect or only an early visual field loss in either eye (mean deviation lesser than -6 dB). -Post-washout IOP ≥ 22 mmHg in at least one eye . If IOP is <22 mmHg, wash-out period can be extended, IOP should be re-assessed 2 to 3 days after the first measurement. If the IOP is still < 22 mmHg at the second measurement, a third assessment should be performed 2 to 3 days after the second measurement. -Post-washout IOP ≤ 32 mmHg in both eyes. |
|
E.4 | Principal exclusion criteria |
-Any form of glaucoma other than primary open angle glaucoma, pseudo exfoliative glaucoma, and pigmentary glaucoma in either eye. -IOP at any time point during the Screening or Baseline visits (Visits 1 or 2) of > 32 mmHg in either eye. -Current treatment for glaucoma with a fixed-combination therapy or more than one drug or with an oral drug within 6 months prior to screening. -Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer in either eye. -Central corneal thickness ≤ 480 μm or ≥ 600 μm in either eye (historical value or at the screening visit) -Significant visual field loss (absolute defect in the 10° central point or mean deviation worse than -12 dB) or progressive field loss during the year before screening. -Significant optic nerve abnormality, other than glaucomatous abnormalities in the opinion of the investigator as determined by ophthalmoscopy. -Significant changes of the optic neuropathy (e.g. increase cupping since the last examination, optic nerve hemorrhage) -Inability to visualize the patient's optic nerve. -Gonioscopy consistent with potential angle closure glaucoma. -Patients with severe blepharitis and/or Meibomian Gland Disease (MGD). Patients enrolled with mild to moderate blepharitis and/or MGD should be treated as appropriate during the study -Known hypersensitivity to sulfonamides, severe renal impairment or hyperchloraemic acidosis. -Any active ocular disease -Intraocular surgery within 6 months prior to screening. -Past history of any filtering surgery for glaucoma. -Refractive surgery of any type within 1 year prior to screening -Anticipated alteration in chronic therapy with or introduction of agents known to have a substantial effect on IOP |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the change in Intra Ocular Pressure (IOP)
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Efficacy: The change from baseline in peak (9:00 am ± 1 hour) and trough (4:00 pm ± 1 hour) IOPs, respectively, at Week 12 between the two treatment groups in the study eye.
|
|
E.5.2 | Secondary end point(s) |
The key secondary endpoints are: •Change in Corneal Fluorescein Staining (CFS) in the study eye in patients with baseline CFS ≥ 1. •Change in OSD symptom score in the study eye in patients with baseline symptom average score>0 Safety and Tolerability: •The incidence and severity of ocular and systemic adverse events •Best-corrected distance visual acuity (BCDVA) •Slit lamp examination (lashes, anterior chamber and lens). •Dilated and undilated (cup-to-disc ratio) fundoscopy |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
•Change from baseline in CFS score at Week 12 with baseline CFS ≥ 1 •Change from baseline in OSD symptom score (average of 3 symptoms) at Week 12 with baseline symptom average score>0 Safety and Tolerability: At all visits and for each treatment (Period 1) and for the Open-Label population for DE-130A at all visits (Period 2 and Periods 1 & 2 combined), |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Period 1: investigator-masked; Period 2: open-label |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 41 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Korea, Republic of |
Russian Federation |
Austria |
Belgium |
Estonia |
Finland |
France |
Germany |
Italy |
Latvia |
Poland |
Spain |
United Kingdom |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 9 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |