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Open Label, Sequential-dose Study of PA5108 Latanoprost FA SR Ocular Implant for Mild-moderate Glaucoma

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ClinicalTrials.gov Identifier: NCT04060758
Recruitment Status : Not yet recruiting
First Posted : August 19, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
PolyActiva Pty Ltd

Brief Summary:
This is a multi-centre, open label, interventional, comparative, phase I study to identify a safe and efficacious dose (within the range of 16.2 to 60 microgram) of PA5108 (PolyActiva product code) Latanoprost free acid (FA) sustained release (SR) Ocular Implant in adults who have Open Angle Glaucoma (Primary or Secondary) or Ocular Hypertension.

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Drug: PA5108 Latanoprost FA SR Ocular Implant Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Comparative, Sequential-dose, Multi-centre Study Involving Intracameral Administration of a PA5108 Latanoprost FA SR Ocular Implant Into the Eye of Patients With Mild-moderate Glaucoma
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost

Arm Intervention/treatment
Experimental: 60 microgram
PA5108 Latanoprost FA SR Ocular Implant which releases 60 microgram
Drug: PA5108 Latanoprost FA SR Ocular Implant
Ocular Implant
Other Name: PA5108

Experimental: 30 microgram
PA5108 Latanoprost FA SR Ocular Implant which releases 30 microgram
Drug: PA5108 Latanoprost FA SR Ocular Implant
Ocular Implant
Other Name: PA5108

Experimental: 45 microgram
PA5108 Latanoprost FA SR Ocular Implant which releases 45 microgram
Drug: PA5108 Latanoprost FA SR Ocular Implant
Ocular Implant
Other Name: PA5108

Experimental: 16.2 microgram
PA5108 Latanoprost FA SR Ocular Implant which releases 16.2 microgram. Inclusion of this arm is dependent on result of 30 microgram arm.
Drug: PA5108 Latanoprost FA SR Ocular Implant
Ocular Implant
Other Name: PA5108




Primary Outcome Measures :
  1. Effective dose [ Time Frame: Intraocular Pressure (IOP) change measured at; baseline, week 12 and week 26. ]
    Determine the minimum effective dose (as daily release rate of LtpFA) that achieves an IOP lowering effect >20% with minimal adverse events.

  2. Safety and Tolerability-incidence of treatment emergent Adverse Events [ Time Frame: Incidence of Treatment-Emergent Adverse Events throughout the study (up to 1 year). ]
    Assess the safety and tolerability of PA5108 Latanoprost FA SR Ocular Implant in adults with Open Angle Glaucoma (Primary or Secondary) or Ocular Hypertension. Incidence of Treatment-Emergent Adverse Events from visit 1 until end of study. Safety laboratory evaluations (biochemistry, haematology, urinalysis). Physical examinations and vital signs. Changes in ocular examinations from baseline to end of study.


Secondary Outcome Measures :
  1. Ease of Use [ Time Frame: At visit 2-Day 0, after use of device to insert the implant into the eye. ]
    Assess the ease of use of the bespoke administration device- Administering ophthalmologist's assessment of ease of use of the bespoke administration device, verbal communication.



Information from the National Library of Medicine

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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:

Participants who:

  • Provide written informed consent
  • Are at least 18 years of age.
  • Diagnosis of open angle glaucoma or ocular hypertension. Diagnosis of open angle glaucoma must be classified as Grade 3 or 4 on the modified Shaffer-Etienne scale. Diagnosis of ocular hypertension must be without evidence of disc or visual field change.
  • Unmedicated (post-washout) 8:00am IOP ≥ 24 mmHg and ≤ 36mmHg in the intent to treat eye at either of two qualification visits 2 weeks apart. Additionally, the IOP at 12:00 and 16:00 hrs must be ≥ 20mmHg and ≤ 36mmHg on the same qualification visit where the 8:00am IOP was IOP ≥ 24 mmHg and ≤ 36mmHg.
  • Corrected visual acuity in each eye no less than (+0.3logMAR) or better by Early Treatment of Diabetic Retinopathy Study (EDTRS) in the study eye (equivalent to 6/12).
  • Minimum endothelial cell density of greater than or equal to 1500 cells per mm2
  • Currently managing their glaucoma with IOP lowering drop therapy, including a prostaglandin analogue.
  • Agree to comply with the contraceptive measures described in the protocol.
  • Are able and willing to follow study instructions and undergo eye examinations

Exclusion Criteria:

Participants who:

  • Have pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
  • Have a history of or current uveitis, cystoid macular oedema (CME), or cornea oedema in the study eye.
  • Have aphakic eyes or only one eye.
  • Have significant corneal guttata in the study eye.
  • Have had any intraocular surgery, glaucoma surgery or cornea/refractive surgery in either eye within the past 6 months or anticipate a need for eye surgery (including laser) in the study eye during the study period.
  • Subjects with Fuchs' Endothelial Corneal Dystrophy (FECD) grade greater than or equal to 1 in the study eye.
  • Have a current retinal detachment or history of blunt trauma in the study eye.
  • Ocular trauma in either eye within the three months prior to screening, or ocular surgery or non-refractive laser treatment within the six months prior to screening or anticipate a need for eye surgery (including laser) in either eye during the study period.
  • Known sensitivity to any component of the product (e.g. latanoprost or polytriazole sensitivity), or to topical therapy used during course of study (e.g. povidone iodine, or anaesthetics).
  • Recent or current evidence of ocular infection or inflammation in either eye. Current evidence of clinically significant blepharitis, conjunctivitis, or a history of herpes simplex or zoster keratitis at screening in either eye.
  • Clinically significant ocular disease in either eye (e.g., corneal oedema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for 4-weeks is not judged safe (e.g., cup-disc ratio > 0.8, severe visual field defect).
  • Ocular medication in either eye of any kind within 30 days of screening, with the exception of a) ocular hypotensive medications (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after screening) or c) lubricating drops for dry eye (which may be used throughout the study).
  • Central corneal thickness in either eye that is less than 470 µm or greater than 630 µm at screening (or a difference between the eyes >70 µm).
  • Any abnormality in either eye preventing reliable applanation tonometry, including aphakic eyes or significant corneal guttatae.
  • Clinically significant systemic disease (as determined by physician) which might interfere with the study.
  • Immunosuppressed patients.
  • Clinically significant abnormalities (as determined by the treating physician) in laboratory tests at screening.
  • Have received any investigational research agent within 30 days or five half-lives (whichever is longer) prior to the administration of the ocular implant.
  • Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
  • Have a known or current alcohol or substance abuse problem.
  • Have progressive or relapsing haematological malignancy, a current solid tumour, or previous malignant solid tumour that is likely to recur during the period of the study (with the exception of a past history of basal or squamous cell carcinomas).
  • Have any other medical, psychiatric, or social condition which, in the opinion of the investigator, makes the participant unsuitable for participation 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): NCT04060758


Contacts
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Contact: Teresa Morgan 0425795597 teresa.morgan@polyactiva.com
Contact: Russell Tait +61396570700 russell.tait@polyactiva.com

Sponsors and Collaborators
PolyActiva Pty Ltd
Investigators
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Principal Investigator: Keith Martin Royal Victoria Eye and Ear Hospital
Principal Investigator: Michael Coote Melbourne Eye Specialists

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Responsible Party: PolyActiva Pty Ltd
ClinicalTrials.gov Identifier: NCT04060758     History of Changes
Other Study ID Numbers: LATA CS102
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Latanoprost
Antihypertensive Agents