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NCT02435914 · ClinicalTrials.gov registry record · Phase 2

Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease

A Phase 2 study, sponsored by Allergan.

Completed
Registry status
Phase 2
Development phase
236
Enrollment target

NCT02435914: Completed Phase 2 study, sponsored by Allergan.

NCT02435914 is a Phase 2 study that has completed, run by Allergan. The registered enrollment target is 236 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02435914, a Phase 2 study, has completed, sponsored by Allergan.

COMPLETED
Registry status
Phase 2
Development phase
236 participants
Enrollment target

Study Summary

This study will evaluate the safety, efficacy, tolerability, and systemic pharmacokinetics of 3 different doses of topical ophthalmic AGN-223575 suspension compared to AGN-223575 vehicle in patients with dry eye disease.

Primary Outcome

Nasal and temporal bulbar conjunctival hyperemia were graded separately in each eye by the investigator under slit-lamp magnification by assigning a score of 0 to 4 for each quadrant based on comparison to the Allergan Dry Eye Redness Scale with photographic reference where: 0=Normal, vessels of bulbar conjunctiva are easily observed; 1=Trace redness; 2=Mild redness; 3=Moderate redness; 4=Severe redness, and each score is associated with a reference photo. For each eye, the study quadrant was de

Interventions

  • DRUG AGN-223575 ophthalmic solution
  • DRUG AGN-223575 vehicle ophthalmic solution

Trial Details

FieldValue
Enrollment Target 236 participants
Start Date 2015-06
Est. Completion 2016-01
Phase Phase 2
Allergan

314 total trials

What the finished NCT02435914 record still lists

NCT02435914 is an interventional study that assigns participants to a tested intervention. The registered 236 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% higher).

The record links to 0 conditions, and to 2 interventions - of which AGN-223575 ophthalmic solution is the first listed.

NCT02435914 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02435914 about?

NCT02435914 is a clinical study titled "Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease". This study will evaluate the safety, efficacy, tolerability, and systemic pharmacokinetics of 3 different doses of topical ophthalmic AGN-223575 suspension compared to AGN-223575 vehicle in patients with dry eye disease.

What is the current status of trial NCT02435914?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 236 participants. The study started on 2015-06. Estimated completion is 2016-01.

What interventions are being tested in trial NCT02435914?

The interventions under investigation include: AGN-223575 ophthalmic solution (DRUG), AGN-223575 vehicle ophthalmic solution (DRUG).

Who is sponsoring clinical trial NCT02435914?

This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02435914's enrollment target sits among peer trials

236 255th of 2000 higher than 1,746 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02435914, the US trial registry maintained by the National Library of Medicine. NCT02435914 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.