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NCT02688556 · ClinicalTrials.gov registry record · Phase 3

Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

A Phase 3 study, sponsored by Sun Pharmaceutical Industries Limited.

Completed
Registry status
Phase 3
Development phase
745
Enrollment target

NCT02688556 is a Phase 3 study that has completed, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 745 participants.

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The verdict

NCT02688556, a Phase 3 study, has completed, sponsored by Sun Pharmaceutical Industries Limited.

COMPLETED
Registry status
Phase 3
Development phase
745 participants
Enrollment target

Study Summary

This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50 sites.

Interventions

  • DRUG cyclosporine
  • DRUG vehicle of OTX-101

Trial Details

FieldValue
Enrollment Target 745 participants
Start Date 2016-02
Est. Completion 2016-12
Phase Phase 3

What the Registry Record Tells You About NCT02688556

The ClinicalTrials.gov registry entry for NCT02688556 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 745 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sun Pharmaceutical Industries Limited, which has 38 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which cyclosporine is the first listed.

NCT02688556 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02688556 about?

NCT02688556 is a clinical study titled "Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca". This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50 sites.

What is the current status of trial NCT02688556?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 745 participants. The study started on 2016-02. Estimated completion is 2016-12.

What interventions are being tested in trial NCT02688556?

The interventions under investigation include: cyclosporine (DRUG), vehicle of OTX-101 (DRUG).

Who is sponsoring clinical trial NCT02688556?

This trial is sponsored by Sun Pharmaceutical Industries Limited, which has 38 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.