A Phase III, Multinational, Multicenter, Investigator-Masked, Randomized, Active-Controlled Trial, comparing the efficacy and safety of DE-130A with Xalatan® in Patients with Open-Angle Glaucoma or Ocular Hypertension over a 3-Month period, followed by a 12-Month Follow-Up with Open-Label DE-130A Treatment.
Phase III, prospective, interventional, multinational, multicentre, investigator-masked, randomized, active-controlled trial Study duration: * 5 days to 5-week washout period * 15 months for the first 130 patients * 12 weeks for the next 250 patients Patients will attend 6 visits following the wash-out phase (up to 5 weeks): * Period 1 (3-month investigator-masked treatment period, DE-130A vs Xalatan®): Randomization/Baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days) * Period 2 (12-month follow-up from Week 12, open-label DE-130A treatment for the first 130 patients who complete their week 12 visit and agree to participate in the open-label period of the study): Month 6 (± 7days), Month 9 (±7 days) and Month 15 (± 1 week) visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
386
Latanoprost 50 microg/ml eye drops emulsion, preservative-free eye drops emulsion in single-dose containers.
Latanoprost 50 microg/ml eye drops solution, eye drops in 2.5 ml dropper containers.
After Week 12, received DE-130A continuously.
From week 12 onwards, DE-130A was continued to be administered instead of Xalatan®.
Hôpital des XV-XX
Paris, Île-de-France Region, France
Intraocular Pressure (IOP) Change (mmHg) at Week 12
Intraocular Pressure (IOP) change from baseline peak (mmHg). IOP was measured using calibrated Goldman applanation tonometer in the morning (9:00 am ± 1 hour). Analysis using Mixed-Effects Model for Repeated Measures (MMRM).
Time frame: Week 12 (09:00) peak timepoint
Intraocular Pressure (IOP) Change (mmHg) at Week 12
Intraocular Pressure (IOP) change from baseline trough (mmHg). IOP was measured using calibrated Goldman applanation tonometer in the afternoon (4:00 pm ± 1 hour). Analysis using Mixed-Effects Model for Repeated Measures (MMRM).
Time frame: Week 12 (16:00) trough timepoint
Corneal Fluorescein Staining (CFS) Change From Baseline (First Key Secondary Endpoint)
CFS Change from baseline in participants with baseline CFS score ≥ 1 at Week 12 Staining using fluorescein were graded using the Modified Oxford scale (7-point ordinal scale, score 0, 0.5, and 1 to 5 per area for cornea and conjunctiva separately) as shown below: * Score = 0: No staining dots * Score = 0.5: One staining dot per area * Score = 1: More staining dot per area than score 0.5 * Score = 2: More staining dot per area than score 1 * Score = 3: More staining dot per area than score 2 * Score = 4: More staining dot per area than score 3 * Score = 5: More staining dot per area than score 4 A Mixed-Effects Model for Repeated Measures (MMRM) was fitted to the CFS change from baseline at each visit.
Time frame: Week 12
Ocular Surface Disease (OSD) Symptoms (Average of 3 Symptoms); Second Key Secondary Endpoint
Change from baseline in OSD symptom score (average of 3 symptoms: dry eye sensation, blurred/poor vision and burning/stinging/itching) in the study eye at Week 12 in patients with baseline symptom average score\>0. Ocular symptoms were graded on a 5-point scale as shown below: * Scale = 0: Absent * Scale = 1: Mild * Scale = 2: Moderate * Scale = 3: Severe * Scale = 4: Very severe Least Square Means and p-values were obtained by fitting a Mixed-Effects Model for Repeated Measures (MMRM) model to the Ocular Surface Disease (OSD) average change from baseline at each visit.
Time frame: Week 12
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