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A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients with Open-Angle Glaucoma or Ocular Hypertension

PHRR160714-001306

192024-093

2016-CT0347

A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients with Open-Angle Glaucoma or Ocular Hypertension

multicenter, paired-eye, randomized, efficacy evaluator-masked 14-month
study

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2018-08-20 14 2019-10-20 0000-00-00

Ongoing

Institution Classification Region LTO #
Allergan (North America) Private Business United States of America N/A
Institution Classification Region LTO #
PAREXEL Clinical Research (Philippines) Ltd. Corp. Private Business NCR CDRR-NCR-CRO-4
Institution Region
Allergan (North America) United States of America
Name E-Mail Institution and Institution Address
Jan Banaticla Jan.Banaticla@allergan.com 21st Floor Robinsons Cyberscape Beta, Topaz & Ruby Road, Ortigas Center, Pasig City 1605 Philippines
Name E-Mail Institution and Institution Address
Jean Lou MD Lou_Jean@allergan.com 2525 Dupont Drive Irvine, California USA 92612
Name Expertise Affiliation
Harvey Uy, MD Principal Investigator Peregrine Eye and Laser Institute
Maria Imelda Veloso, MD Principal Investigator Asian Eye Institute
Nilo Vincent de Guzman Florcruz, MD Principal Investigator American Eye Center
Patricia Khu, MD Principal Investigator Cardinal Santos Medical Center
Project Location Institutional Ethics Review Board
Peregrine Eye and Laser Institute Peregrine Eye and Laser Institute Institutional Review Board
Asian Eye Institute Asian Eye Institute Ethics Review Committee
American Eye Center N/A
Cardinal Santos Medical Center Cardinal Santos Medical Center Ethics Review Committee

Open-Angle Glaucoma or Ocular Hypertension

ocular pressure (IOP)-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty (SLT) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT)

Unspecified

Recruiting

  • Australia
  • Canada
  • Estonia
  • Germany
  • Israel
  • New Zealand
  • Philippines
  • United Kingdom
  • United States

Clinical Trial

192024-093

20160218122310

2016-07-05

0000-00-00

10

8

Unspecified

2018-08-20

Inclusion Criteria

The following are requirements for entry into the study:

1. Male or female, 18 years of age or older

2. Written informed consent and authorization for use and release of personal health information are obtained in accordance with the relevant country and local privacy requirements, where applicable and written Data Protection consent

3. Patient is willing to withhold his/her IOP treatments according to the study requirements, and in the opinion of the investigator, can do so without significant risk. Note: If patients cannot discontinue their current prescribed therapy for up to 6 weeks to meet the Washout period for study entry, the investigator may switch the patient's medication to one that requires a shorter washout interval during the washout of the original medication

4. Patient has the ability to understand and the willingness to follow study instructions and requirements and is likely to complete all required visits and procedures

5. In the investigator’s opinion, patient’s IOP is not adequately managed with topical medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence)

6. Negative pregnancy test or Baseline for females of childbearing potential

Ocular Inclusion Criteria for Both Eyes
7. In the investigator’s opinion, both eyes can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog (eg, LUMIGAN, Xalatan®, Travatan®) eye drops as the sole therapy if medication was taken as directed

8. In the investigator’s opinion, patient’s IOP can be adequately managed with SLT monotherapy

9. In the investigator’s opinion, patient is a suitable candidate for SLT

10. Diagnosis of either OAG (ie, primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or OHT in each eye, requiring bilateral IOP-lowering treatment (Note: diagnosis does not have to be the same in both eyes)

11. Central endothelial cell density by specular microscopy confirmed as being qualified by Reading Center assessment prior to beginning Washout

12. The iridocorneal angle inferiorly must be independently confirmed as being qualified by 2 ophthalmologists using the following criteria:

a. Shaffer Grade ≥ 3 on clinical gonioscopy of the inferior angle

b. Peripheral anterior chamber depth by Van Herick examination ≥ 1/2 corneal thickness

Note: The independent eligibility assessments must both agree that the Shaffer grade is ≥3 an dthe Van Herick grade is ≥ 1/2 corneal thickness

13. At the Baseline visit, patient has been appropriately washed out of all IOP-lowering medications

14. At the Baseline visit (8:00 AM ± 1 hour), IOP of ≥ 22 and ≤ 34 mm Hg, with difference between eyes of ≤ 5 mm Hg

15. At the Screening and Baseline (Day -3 to -1) visits, Best-Corrected Visual Acuity (Snellen equivalent, by manifest refraction) of 20/50 or better in each eye.

Exclusion Criteria

The following are criteria for exclusion from participating in the study:

1. Uncontrolled systemic disease

2. Females who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study

3. Known allergy or sensitivity to the study medication or its components, any component of the delivery vehicle, or any diagnostic or surgical prep agents used during the study

4. Any condition which would preclude the patient's ability to comply with study requirements (including completion of the study)

5. Patients who have a condition or are in a situation, which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study

6. Concurrent or anticipated enrollment in an investigational drug or device study or participation in such a study from 2 months prior to Baseline visit through the final study visit

7. Previous or concurrent enrolment in another Allergan Bimatoprost SR study

8. Known history of bleeding disorder or prolonged bleeding after surgery (in the opinion of the investigator). Note: Patients receiving pharmacologic blood thinners (eg. aspirin, Coumadin) may be enrolled at the investigator's discretion.

Ocular Exclusion Criteria for Both Eyes:

9. History of previous laser trabeculoplasty

10. History or evidence of clinically relevant, substantial ocular trauma (eg. a traumatic cataract, traumatic angle recession, etc.)

11. The following surgical history:

a. History or evidence of complicated cataract surgery: eg. surgery resulting in complicated lens placement (such as anterior chamber intraocular lens implant [IOL], sulcus IOL, aphakia, etc) or intraoperative complications (such as posterior capsule tear [with or without vitreous loss], sustantial iris trauma, etc).

Note: history of uncomplicated cataract surgery is not an exclusion

b. History of phakic IOL inserton for refractive error correction

12. Intraocular surgery (including cataract surgery) and/or any ocular laser surgery within the 6 months prior to treatment (Day 1)

13. Any history of corneal graft, including partial grafts (eg. Descemet's Stripping Endothelial Keratoplasty [DESK], Descemet's Membrane Endothelial Keratoplasty [DMEK]; or incisional refractive surgery (eg. radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions

14. Corneal or other ocular abnormalities that would preclude accurate readings with an applanation tonometer, anterior segment-optical coherence tomography, specular microscope, and/or a contact pachymeter, or could confound study results, eg. moderate to severe corneal dystrophy, including Anterior Basement Membrane Disease (ABMD; ie, Map-Dot-Fingerprint [MDF]) and guttata. Mild ABMD or mild guttata are not exclusionary by clinical examination if, in the opinion of the investigator, the condition is stable and not likely to cause corneal changes during the course of the study.

15. Active or recurrent ocular disease (eg. uveitis, ocular infection, chronic moderate to severe blepharitis or severe dry eye, severe ocular seasonal allergies) or sight threatening diseases (eg, neovascular age-related macular degeneration [ARMD], diabetic macular edema) that, in the opinion of the investigator, would put the patient at a significant risk or would interfere with the interpretation of the study data. Patients with slowly progressive eye diseases (ei, mild cataracts, nonneovascular ARMD) can be enrolled at the discretion of the investigator.

16. Any history of external ocular or intraocular malignancy, and/or any history of benign ocular neoplasia that in the investigator's opinion resulted in clinically significant ocular morbidity

17. History of hepatic ocular diseases (including herpes simplex virus and varicella zoster virus)

18. The following ocular surface findings:

a. Bulbar conjunctival hyperemia, on either macroscopic or slit-lamp examination, >+1 (mild) at baseline

b. Active ocular surface findings other than bulbar conjunctival hyperemia, on either macroscopic or slit-lamp examination, >+1 (mild) at Baseline

19. History of moderate or worse (≥+2) bulbar conjunctival hyperemia due to marketed prostaglandin, prostamide, or prostaglandin analog use

20. The anticipated wearing of contact lenses during the study that deviates from the following (contact lens wear is allowed during the study, but is to be temporarily discontinued before study visits, and before and after an Administration Day according to the following:

a. Use of soft lenses should be discontinued at least 3 days prior to Baseline, and use of rigid gas permeable or hard contact lenses should be discontinued at least 1 week prior to Baseline

b. Use of soft lenses should be discontinued at least 3 days and use of rigid gas permeable or hard contact lenses should be discontinued at least 1 week prior to a scheduled study visit or Administration Day visit

c. Use of contact lenses of any kind should be discontinued for 1 week following any Bimatoprost SR (or Sham) administration

21. Central corneal thickness of < 480 or > 620 micrometers

22. Anticipated  need for any incisional or laser ocular surgery during the study

23. History of anatomically narrow angle resulting in evidence of angle changes or any history of closed angle glaucoma. Note: historically narrow angled patients whose angle has been opened by cataract surgery or peripheral iridotomy may be eligible for enrollment if they have no evidence of angle abnormalities.

24. History or evidence of a peripheral iridotormy/iridectomy in the inferior iris

25. Any history of trabeculectomy or other types of glaucoma surgery, including a glaucoma seton or aqueous bypass stents

26. Peripheral anterior synechiae (PAS) in the inferior iridocorneal angle on gonioscopic examination at Screening

27. Visual field loss that, in the opinion of the investigator, is functionally significant (eg, split fixation, field defect within the central 10 degrees that is visually significant or likely to cause central visual impairment upon progression) or shows evidence of progressive visual field loss within the year prior to baseline (Note: Two visual fields are required for qualification, 1 performed within the 10 months prior to or at Screening, and 1 performed at baseline during the washout period using the protocol-required testing method. The same test methodology should be used for all historical and study-related examination for a given patient.)

28. Evidence of macular edema during screening or in patient's medical history

29. Anticipated use of corticosteroids in either eye (except as described in Section 4.4.4 [Permissible Medications/Treatments]) or systemically during the study, or historical use prior to Baseline within:

- 3 years: intraocular fluocinolone acetonide

- 6 months: intraocular corticosteroid(s) other that fluocinolone; any injectable periocular or sub-Tenon's/subconjunctivital corticosteroid

- 2 months: systemic (eg. oral, intramuscular, intravenous) or topical ocular corticosteroids

- 2 weeks: dermal corticosteroids applied to skin of the eyelid(s), around the eye, or adnexa

30. Anticipated use of other topical ocular medications except as described in Section 4.4.4 (Permissible Medications/Treatments)

Interventional

Bimatoprost SR 15 μg; Bimatoprost SR 10 μg

Bimatoprost SR 15 μg, Bimatoprost SR 10 μg and 360° SLT administration

Date Amendment Classification Reason
2016-08-02 Amendments related to the trial arrangements Change of the trial site or addition of new site
2016-08-02 Amendments related to the trial arrangements Change of the principal investigator or addition of new ones
2019-01-08 Amendments related to the protocol Informed consent
2019-11-11 Amendments related to the protocol Informed consent
2018-11-20 Amendments related to the protocol Protocol Amendment 3 dated 05 Sep 2018
2018-05-03 Amendments related to the protocol Informed consent
2017-12-12 Amendments related to the protocol (1) 192024-093 NEI-VFQ25_IA - United States/English V1.0 dated 27Jul2017 (2) 192024-093 NEI-VFQ25_IA - Philippines/Tagalog V1.0 dated 10Oct2017
2017-08-22 Amendments related to the protocol (1) Protocol Amendment 2 dated 01 May 2017 (2) 192024-093 Philippines ICF/Country Level v3.0 05Jun2017_ENG (3) 192024-093 Philippines ICF/Country Level v3.0 05Jun2017_TAG
2016-09-16 Amendments related to the trial arrangements Change of the trial site or addition of new site
2016-09-26 Amendments related to the protocol Informed consent
2020-03-26 Amendments related to the protocol Protocol Amendment 4 dated 31 Jan 2020 and ICF v7.0 14 Feb 2020
2020-12-28 Amendments related to the protocol Protocol 192024-093 Amendment 6 dated 28 Aug 2020; Informed Consent Form v9.0 30 Oct 2020 (English and Tagalog)

Randomized

Double Blind

Unspecified

Parallel

evaluate the intraocular pressure (IOP)-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty (SLT) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence)

Phase III

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