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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: Completed Phase 3 study, sponsored by Sun Pharmaceutical Industries Limited.

NCT02688556 is a Phase 3 study that has completed, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 745 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Percentage of Eyes with Increase from Baseline of ≥ 10 mm in Schirmer's Test Score

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 finished NCT02688556 record still lists

NCT02688556 is an interventional study that assigns participants to a tested intervention. The registered 745 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

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

NCT02688556 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02688556's enrollment target sits among peer trials

745 475th of 2000 higher than 1,526 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT02688556, the US trial registry maintained by the National Library of Medicine. NCT02688556 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.