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COMPLETED Phase 2

Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery

NCT01666210 · View on ClinicalTrials.gov ↗

Study Summary

To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of ocular inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.

Interventions

  • DRUG OTX-DP (Dexamethasone punctum plug)
  • DRUG Placebo Vehicle Punctum Plug

Study Locations (1)

Illinois

  • Chicago Cornea Consultants, Ltd. — Hoffman Estates

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2012-10
Est. Completion 2013-08
Phase Phase 2

Sponsor

Ocular Therapeutix

39 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01666210

The ClinicalTrials.gov registry entry for NCT01666210 describes a study currently listed as completed. It is categorized as Phase 2, 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 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ocular Therapeutix, which has 39 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Ocular Inflammation and Pain appearing as the primary indexed condition, and to 2 interventions — of which OTX-DP (Dexamethasone punctum plug) 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: NCT01666210 reports 1 study location spanning 1 distinct geographic area — top geographies include Illinois. 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 NCT01666210 about?

NCT01666210 is a clinical study titled "Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery". To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of ocular inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.

What is the current status of trial NCT01666210?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2012-10. Estimated completion is 2013-08.

What conditions does trial NCT01666210 study?

This clinical trial studies the following conditions: Ocular Inflammation and Pain. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01666210?

The interventions under investigation include: OTX-DP (Dexamethasone punctum plug) (DRUG), Placebo Vehicle Punctum Plug (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01666210?

This trial is sponsored by Ocular Therapeutix, which has 39 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01666210 being conducted?

This trial has 1 study location across Illinois. 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