Open-Angle Glaucoma or Ocular Hypertension MedDRA version: 20.0 Level: PT Classification code 10030348 Term: Open angle glaucoma System Organ Class: 10015919 - Eye disorders MedDRA version: 20.0 Level: PT Classification code 10030043 Term: Ocular hypertension System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Code: DE-130A
Pharmaceutical Form: Eye drops, emulsion
INN or Proposed INN: LATANOPROST
Other descriptive name: LATANOPROST
Conc
Sponsors
Santen SAS
Eligibility
Sex/Gender
All
Inclusion criteria
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. -Post-washout IOP = 22 mmHg in at least one eye -Post-washout IOP = 32 mmHg in both eyes 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 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 305
Exclusion criteria
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 -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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The key secondary endpoints are: •Change in Corneal Fluorescein Staining (CFS) •Change in OSD symptom score Safety and Tolerability: •The incidence and severity of ocular and systemic adverse events •Best-corrected distance visual acuity •Slit lamp examination (lashes, anterior chamber and lens). •Dilated fundoscopy ; Timepoint(s) of evaluation of this end point: •Change from baseline in CFS score at Week 12 •Change from baseline in OSD symptom score (average of 3 symptoms) at Week 12 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), | — |
Primary
| Measure | Time frame |
|---|---|
| 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. ;Main Objective: 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).; Secondary Objective: - To compare the effect on improving OSD signs and symptoms between treatment groups [for the FAS population and by corneal fluorescein staining (CFS) subgroups, baseline study eye CFS = 1 vs. CFS = 2, modified Oxford scale] over 3 months (Period 1). - To estimate the effect of DE-130A on OSD signs and symptoms for the Open-Label population and by OSD subgroups up to 15 months (Periods 1 & 2). - To compare the efficacy on IOP reduction between treatment groups for the FAS population and OSD subgroups over 3 months (Period 1). - To estimate the effect of DE-130A on IOP for the Open-Label population and by OSD subgroups up to 15 months (Periods 1 & 2). - To evaluate the local ocular tolerance and systemic safety of the two treatments over 3 months (Period 1, Safety population). - To estimate the local ocular tolerance and systemic safety of DE-130A up to 15 months (Periods 1 & 2, Open-Label population). ; Primary end point(s): The primary efficacy endpoint is the change in Intra Ocular Pressure (IOP) | — |
Countries
Estonia, Finland, France, Germany, Italy, Korea, Republic of, Poland, Russian Federation, Spain, United Kingdom
Contacts
Public ContactRegulatory Affairs EMEA
Santen SAS
Outcome results
None listed