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NCT03088605 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of TOP1630 for Dry Eye Syndrome

A Phase 2 study, sponsored by ORA.

Completed
Registry status
Phase 2
Development phase
69
Enrollment target

NCT03088605: Completed Phase 2 study, sponsored by ORA.

NCT03088605 is a Phase 2 study that has completed, run by ORA. The registered enrollment target is 69 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03088605, a Phase 2 study, has completed, sponsored by ORA.

COMPLETED
Registry status
Phase 2
Development phase
69 participants
Enrollment target

Study Summary

In subjects with Dry Eye Syndrome: The primary objective of this study is to compare the safety and tolerability of TOP1630 Ophthalmic Solution to placebo. The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye syndrome.

Primary Outcome

Visual Acuity will be measured using the EDTRS chart to assess changes from baseline

Interventions

  • DRUG TOP1630 Ophthalmic Solution
  • DRUG Placebo to TOP1630 Ophthalmic Solution

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2017-02-20
Est. Completion 2017-06-15
Phase Phase 2
ORA

19 total trials

What the finished NCT03088605 record still lists

NCT03088605 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower).

The record links to 0 conditions, and to 2 interventions - of which TOP1630 Ophthalmic Solution is the first listed.

NCT03088605 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03088605 about?

NCT03088605 is a clinical study titled "Safety and Efficacy of TOP1630 for Dry Eye Syndrome". In subjects with Dry Eye Syndrome: The primary objective of this study is to compare the safety and tolerability of TOP1630 Ophthalmic Solution to placebo. The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of ...

What is the current status of trial NCT03088605?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2017-02-20. Estimated completion is 2017-06-15.

What interventions are being tested in trial NCT03088605?

The interventions under investigation include: TOP1630 Ophthalmic Solution (DRUG), Placebo to TOP1630 Ophthalmic Solution (DRUG).

Who is sponsoring clinical trial NCT03088605?

This trial is sponsored by ORA, which has 19 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03088605's enrollment target sits among peer trials

69 965th of 2000 higher than 1,034 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 NCT03088605, the US trial registry maintained by the National Library of Medicine. NCT03088605 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.