Phase 3
Completed N=682
Evaluation of Safety and Efficacy of PDP-716
Source: ClinicalTrials.gov NCT03450629 ↗Enrolled (actual)
682
Serious AEs
0.6%
Results posted
Feb 2022
Primary outcomePrimary: Change From Baseline in Mean Intraocular Pressure — 20.35; 20.79; 17.38; 18.31 mmHg — p=0.0006
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The study will be conducted to evaluate the efficacy and safety of topical administration of PDP-716 compared with brimonidine tartrate ophthalmic solution.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Intraocular Pressure |
20.35; 20.79; 17.38; 18.31; 17.99; 17.57 | 0.0006 sig |
Eligibility Criteria
Inclusion Criteria
- Be male or female, of 2 years of age or older
- Have open-angle glaucoma or ocular hypertension in both the eyes
- Be able and willing to follow study instructions and complete all required visits.
Exclusion Criteria
- Females who are pregnant/lactating.
- Have uncontrolled systemic disease which might interfere with the study
- Any known allergy or sensitivity to the study medications or their components
- Any other clinically relevant abnormality
Data sourced from ClinicalTrials.gov (NCT03450629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.