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

NCT04133311 | Completed Phase 3 Results

• 1 other identifier: 0130A01SA
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Open-Angle Glaucoma or Ocular Hypertension; Ocular Surface Disease

Keywords

IOP; OSD

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  Week 12 (16:00) trough timepoint

Secondary Outcomes (2)

• Corneal Fluorescein Staining (CFS) Change From Baseline (First Key Secondary Endpoint)

  Week 12

• Ocular Surface Disease (OSD) Symptoms (Average of 3 Symptoms); Second Key Secondary Endpoint

  Week 12

Study Arms (4)

DE-130A

EXPERIMENTAL

Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT

Drug: DE-130A

Xalatan®

ACTIVE COMPARATOR

Instillation of one drop, once daily in the evening (9 pm ± 1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT

Drug: Xalatan®

DE-130A/DE-130A

OTHER

After 12 weeks, continue to use DE-130A once daily for an additional 12 months.

Drug: DE-130A/DE-130A

Xalatan®/DE-130A

OTHER

After 12 weeks, use DE-130A instead of Xalatan® once daily for an additional 12 months.

Drug: Xalatan®/DE-130A

Interventions

DE-130A DRUG

Latanoprost 50 microg/ml eye drops emulsion, preservative-free eye drops emulsion in single-dose containers.

Also known as: Catiolanze®

DE-130A

Xalatan® DRUG

Latanoprost 50 microg/ml eye drops solution, eye drops in 2.5 ml dropper containers.

Xalatan®

DE-130A/DE-130A DRUG

After Week 12, received DE-130A continuously.

Also known as: Catiolanze®

DE-130A/DE-130A

Xalatan®/DE-130A DRUG

From week 12 onwards, DE-130A was continued to be administered instead of Xalatan®.

Also known as: Catiolanze®

Xalatan®/DE-130A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years of age or older
• The patient has signed and dated a written informed consent form and any required privacy authorization prior to the conduct of any study procedures.
• 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 (based on at least two visual fields available within the last 18 months prior to screening, including one in the last 6 months; A visual field test will be performed at screening if not already performed within the last 6 months prior to screening) in each eye.
• Post-washout IOP ≥ 22 mmHg in at least one eye (defined at baseline visit \[Day 1\] by IOP measurement at both 9:00 am ± 1 hour and 4:00 pm ±1 hour)
• Post-washout IOP ≤ 32 mmHg (defined at baseline visit \[Day 1\] by IOP measurement at both 9:00 am ±1 hour and 4:00 pm ±1 hour) in both eyes.
• Ability to discontinue their current topical IOP-lowering medication for the required washout period. Washout periods should be as follows;
• Prostaglandin analogs = 4 weeks
• Topical beta blockers ≥ 3 weeks and ≤ 4 weeks
• Topical carbonic anhydrase inhibitors ≥ 5 days and ≤ 4 weeks
• All other IOP lowering medication ≥ 2 weeks and ≤ 4 weeks
• Snellen best corrected visual acuity score of 20/100 or better in each eye
• Patient must be willing to discontinue wearing contact lenses during the study.

You may not qualify if:

• 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 in either eye 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 data 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 in either.
• Significant optic nerve abnormality, other than glaucomatous abnormalities in the opinion of the investigator as determined by ophthalmoscopy in either eye.
• Significant changes of the optic neuropathy (e.g. increase cupping since the last examination, optic nerve hemorrhage) in either eye.
• Inability to visualize the patient's optic nerve in either eye.
• Gonioscopy consistent with potential angle closure glaucoma in either eye.
• 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 in either eye.
• Use of oral or topical ophthalmic steroid within the past 14 days from screening date, or anticipated need for ocular steroid treatment during the study in either eye.
• Use of intravitreal or peribulbar injection of depot steroid or placement of an intravitreal steroid implant within the past 3 months from screening date in either eye.
• Known allergy or sensitivity to the study medications.
• Active or expected ocular allergy during period 1.

Sponsors & Collaborators

• Santen SAS: lead

Study Sites (1)

Hôpital des XV-XX

Paris, Île-de-France Region, 75012, France

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Director of R&D Quality Management
• Organization: Santen Inc

evelyn.chikere@santen.com

15106851794

Study Officials

• Jean-Sebastien Garrigue, PhD

  Santen SAS

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 21, 2019
• Study Start: April 10, 2019
• Primary Completion: February 3, 2022
• Study Completion: October 26, 2022
• Last Updated: May 28, 2024
• Results First Posted: May 28, 2024

Record last verified: 2024-05

Locations

FR (1)