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COMPLETED Phase 3

Evaluation of Safety and Efficacy of PDP-716

NCT03450629 · View on ClinicalTrials.gov ↗

Study Summary

The study will be conducted to evaluate the efficacy and safety of topical administration of PDP-716 compared with brimonidine tartrate ophthalmic solution.

Interventions

  • DRUG Brimonidine Tartrate Ophthalmic Suspension
  • DRUG Brimonidine Tartrate Ophthalmic Solution

Study Locations (20)

Florida

  • SPARC Site 11 — Coral Springs
  • SPARC Site 29 — Deerfield Beach
  • SPARC Site 34 — Fort Myers
  • SPARC Site 46 — Hollywood
  • SPARC Site 21 — Jacksonville
  • SPARC Site 35 — Miami
  • SPARC Site 27 — Miami
  • SPARC Site 10 — Miami
  • SPARC Site 16 — Miami

California

  • SPARC Site 38 — Burbank
  • SPARC Site 44 — Glendale
  • SPARC Site 45 — Glendale
  • SPARC Site 43 — Mission Hills
  • SPARC Site 1 — Newport Beach
  • SPARC Site 14 — Santa Barbara
  • SPARC Site 47 — Torrance

Arizona

  • SPARC Site 4 — Chandler
  • SPARC Site 5 — Prescott
  • SPARC Site 3 — Sun City

Colorado

  • SPARC Site 7 — Colorado Springs

Trial Details

FieldValue
Enrollment Target 682 participants
Start Date 2018-09-13
Est. Completion 2020-12-01
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03450629

The ClinicalTrials.gov registry entry for NCT03450629 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 682 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sun Pharma Advanced Research Company Limited, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Ocular Hypertension appearing as the primary indexed condition, and to 2 interventions — of which Brimonidine Tartrate Ophthalmic Suspension is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03450629 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03450629 about?

NCT03450629 is a clinical study titled "Evaluation of Safety and Efficacy of PDP-716". The study will be conducted to evaluate the efficacy and safety of topical administration of PDP-716 compared with brimonidine tartrate ophthalmic solution.

What is the current status of trial NCT03450629?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 682 participants. The study started on 2018-09-13. Estimated completion is 2020-12-01.

What conditions does trial NCT03450629 study?

This clinical trial studies the following conditions: Ocular Hypertension, Open Angle Glaucoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03450629?

The interventions under investigation include: Brimonidine Tartrate Ophthalmic Suspension (DRUG), Brimonidine Tartrate Ophthalmic Solution (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03450629?

This trial is sponsored by Sun Pharma Advanced Research Company Limited, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03450629 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial