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This is an open label, single dose (100 ng/day) study to assess the safety, tolerability and biodegradation of the PA5436 Latanoprost FA SR Ocular Implant in adults who have OAG or OHT.
Participants who are currently administering Intraocular Pressure lowering drop therapy for Open Angle Glaucoma or Ocular Hypertension will be recruited.
Prior to recruitment, participants will be medicated with IOP lowering drop therapy, including a prostaglandin analogue to manage their POAG. The IOP lowering eye drops will be stopped in the intent to treat (ITT) eye at least 28 days and no greater than 49 days prior to the date of implant administration.
Participants will be required to have an unmedicated (post washout) 8:00 AM IOP ≥ 24 mmHg and ≤ 36 mmHg in the ITT eye at either of 2 screening visits 2 weeks apart.
Participants are also required to have an unmedicated (post washout) IOP ≥ 20 mmHg and ≤ 36 mmHg at 12:00 noon and 4:00 PM in the same eye on the same screening visit where the 8:00 AM IOP was IOP ≥ 24 mmHg and ≤ 36mmHg.
The PA5346 Latanoprost FA SR Ocular Implant will be administered to one eye (unilateral) of each participant.
IOP will be monitored and if during the course of the study it is found to rise ≥ 30% over baseline in the study eye(s), IOP lowering eye drops will be resumed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Dose 100ng/day PA5346 Latanoprost FA SR Ocular Implant | Experimental | After washout, eligible subjects will be dosed with a single 100ng/day PA5346 Latanoprost FA SR Ocular Implant at study Day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100ng/day PA5346 Latanoprost FA SR Ocular Implant | Drug | PA5346 ocular implant is a small, clear rod-shaped implant that is placed in the anterior (front) chamber of the eye, at a single timepoint, and slowly releases a drug called latanoprost free acid (100ng/day) over a period of approximately 30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in adults with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT). | Clinically significant changes to haematology or biochemistry | Change from baseline to 40 weeks |
| To assess the safety and tolerability of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in adults with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT). | Clinically significant changes to urinalysis | Change from baseline to 40 weeks |
| To assess the safety and tolerability of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in adults with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT). | Clinically significant changes to physical examination | Change from baseline to 40 weeks |
| To assess the safety and tolerability of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in adults with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT). | Clinically significant changes to vital signs | Change from baseline to 40 weeks |
| To assess the safety and tolerability of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in adults with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT). | Clinically significant changes to visual acuity | Change from baseline to 40 weekls |
| To assess the period of biodegradation of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in adults with OAG or OHT. | Biodegradation will be assessed by Gonioscopy or anterior Optical Coherence at Tomography (OCT) at Weeks 6, 12, 18, 26, 34, 40 and each subsequent 6 week visit thereafter until the implant has completely biodegraded. These tests allow the implant to be located by the ophthalmologist. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the initial efficacy of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in controlling IOP during a study period in adults with OAG or OHT. | IOP will be assess by using a tonometer at Day 1, Weeks 6, 18, 26, 34, 40 and every 6 weekly visit after intervention commencement. | Up to 12 months |
| Extent of hyperaemia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tony Wells, MD | Capital Eye Specialists | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Eye Specialists | Te Aro | Wellington Region | 6011 | New Zealand | ||
| Rotorua Eye Clinic |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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|
| Up to 12 months |
Assessed by Slit lamp Biomicroscopy for Conjunctival Redness Day 1, Weeks 6, 18, 26, 34, 40 and every 6 weekly visit after intervention commencement. |
| Up to 12 months |
| Ophthalmologist-reported ease of use of bespoke administration device | This questionnaire is descriptive only and includes questions such as:
| Day 0 |
| Rotorua |
| 3015 |
| New Zealand |