International clinical study comparing the efficacy and safety of DE-130A with Xalatan® in patients with glaucoma (high pressure inside the eye).

Phase 1

• Conditions: 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; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2017-004262-95-GB
• Lead Sponsor: Santen SAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-05
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 380

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified