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A Phase III Multinational Multicenter Investigator-Masked Randomised Active-Controlled Trial Comparing the Efficacy and Safety of DE-130A With Xalatan® in Patients With Open-Angle Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT04133311
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Santen SAS

Brief Summary:
A Phase III, Multinational, Multicenter, Investigator-Masked, Randomised, 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

Condition or disease Intervention/treatment Phase
Open-Angle Glaucoma or Ocular Hypertension Ocular Surface Disease Drug: DE-130A Drug: Xalatan® Phase 3

Detailed Description:

Phase III, prospective, interventional, multinational, multicentre, investigator-masked, randomised, 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®): Randomisation/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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Investigator masked
Primary Purpose: Treatment
Official Title: A Phase III, Multinational, Multicenter, Investigator-Masked, Randomised, Active-Controlled Trial, Comparing the Efficacy and Safety of DE-130A With Xalatan® in Patients With Open-Angle Glaucoma or Ocular Hypertension
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: DE-130A
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
Latanoprost 50 microg/ml eye drops emulsion, eye drops emulsion in single-dose containers

Active Comparator: Xalatan®
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®
Latanoprost 50 microg/ml eye drops solution, eye drops in 2.5 ml dropper containers




Primary Outcome Measures :
  1. IOP reduction (mm Hg) [ Time Frame: Week 12 ]
    Change from baseline (mm Hg)


Secondary Outcome Measures :
  1. Ocular Surface Disease (OSD) symptoms [ Time Frame: Week 12 ]
    Change from baseline in OSD symptom score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, 18 years of age or older
  2. The patient has signed and dated a written informed consent form and any required privacy authorization prior to the conduct of any study procedures.
  3. Diagnosis of OAG (primary open angle glaucoma, pseudo exfoliative glaucoma, or pigmentary glaucoma), or OHT in eligible eye(s) currently on monotherapy.
  4. 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.
  5. Current treatment with monotherapy for OAG or OHT with a controlled IOP ≤ 18 mmHg in each eye (pre-washout).
  6. 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.
  7. 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)
  8. 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.
  9. 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
  10. Snellen best corrected visual acuity score of 20/100 or better in each eye
  11. Patient must be willing to discontinue wearing contact lenses during the study.
  12. Adequate health for study participation as determined by the investigator
  13. In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements
  14. Patient must be willing and able to undergo and return for scheduled study-related examinations.

    -

Exclusion Criteria:

  1. Any form of glaucoma other than primary open angle glaucoma, pseudo exfoliative glaucoma, and pigmentary glaucoma in either eye.
  2. IOP at any time point during the Screening or Baseline visits (Visits 1 or 2) of > 32 mmHg in either eye.
  3. 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.
  4. Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer in either eye.
  5. Central corneal thickness ≤ 480 µm or ≥ 600 µm in either eye (historical data or at the screening visit).
  6. 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.
  7. Significant optic nerve abnormality, other than glaucomatous abnormalities in the opinion of the investigator as determined by ophthalmoscopy in either eye.
  8. Significant changes of the optic neuropathy (e.g. increase cupping since the last examination, optic nerve hemorrhage) in either eye.
  9. Inability to visualize the patient's optic nerve in either eye.
  10. Gonioscopy consistent with potential angle closure glaucoma in either eye.
  11. 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.
  12. 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.
  13. 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.
  14. Known allergy or sensitivity to the study medications.
  15. Active or expected ocular allergy during period 1.
  16. Any active ocular disease (e.g. uveitis, ocular infection, severe dry eye with CFS grade 4 or more on the modified Oxford scale) in either eye. Patients may have mild cataracts, age-related maculopathy or background diabetic retinopathy if, in the opinion of the Investigator, it would not interfere with the conduct of the study.
  17. Intraocular surgery within 6 months prior to screening in either eye.
  18. Past history of any filtering surgery for glaucoma in either eye.
  19. Refractive surgery of any type within 1 year prior to screening in either eye.
  20. Uncontrolled systemic disease of any type.
  21. Anticipated alteration in chronic therapy with or introduction of agents known to have a substantial effect on IOP (e.g., alpha-adrenergic agonists, beta-adrenergic antagonists, calcium channel blockers, ACE inhibitors and/or angiotensin II receptor blockers), unless the subject and the medication dosage have been stable for three months prior to the screening visit and the dosage is not expected to change during the study.
  22. Anticipated change in dosage of or introduction of new medications for chronic cardiac, pulmonary or hypertensive conditions.
  23. Females who are pregnant or lactating and females of child-bearing potential who are not using a medically acceptable, highly effective method of birth control.
  24. Current enrolment in an investigational drug or device study or participation in such a study within 30 days prior to screening.
  25. History of drug or alcohol abuse.
  26. Patient has any condition or situation that, in the Investigator's opinion, might confound the results of the study, may put the patient at significant risk or might interfere with the patient's ability to participate in the study.

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133311


Contacts
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Contact: Santen Pharmaceutical Co., Ltd 81-6-4802-XXXX clinical@santen.co.jp

Locations
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France
Hôpital des XV-XX Recruiting
Paris, Île-de-France, France, 75012
Contact: Christophe Baudouin, Pr    +33 (0)1 40 02 13 04      
Sponsors and Collaborators
Santen SAS
Investigators
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Study Chair: Jean-Sebastien Garrigue, PH Santen SAS

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Responsible Party: Santen SAS
ClinicalTrials.gov Identifier: NCT04133311     History of Changes
Other Study ID Numbers: 0130A01SA
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Santen SAS:
IOP
OSD
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Antihypertensive Agents