5333419
Last Update Posted: 2024-04-12
Recruiting has ended
All Genders accepted | 18 Years + |
1 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Study of a Latanoprost Ocular Implant for Treatment of Open Angle Glaucoma or Ocular Hypertension.
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.
Eligibility
Relevant conditions:
Open Angle Glaucoma
Ocular Hypertension
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
Inclusion criteria
Exclusion criteria
locations
Contact Information
Overall Contact
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Data sourced from ClinicalTrials.gov