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NCT01250925 · ClinicalTrials.gov registry record · Phase 4

Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface

A Phase 4 study, sponsored by Massachusetts Eye and Ear Infirmary.

Completed
Registry status
Phase 4
Development phase
94
Enrollment target

NCT01250925: Completed Phase 4 study, sponsored by Massachusetts Eye and Ear Infirmary.

NCT01250925 is a Phase 4 study that has completed, run by Massachusetts Eye and Ear Infirmary. The registered enrollment target is 94 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01250925, a Phase 4 study, has completed, sponsored by Massachusetts Eye and Ear Infirmary.

COMPLETED
Registry status
Phase 4
Development phase
94 participants
Enrollment target

Study Summary

The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across three lens care regimens in new contact lens wearers.

Primary Outcome

The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

Interventions

  • DRUG ReNu MultiPlus® MultiPurpose Solution
  • DRUG OPTI-FREE® RepleniSH®
  • DRUG Clear Care®

Trial Details

FieldValue
Enrollment Target 94 participants
Start Date 2010-08
Est. Completion 2012-07
Phase Phase 4

What the finished NCT01250925 record still lists

NCT01250925 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 3 interventions - of which ReNu MultiPlus® MultiPurpose Solution is the first listed.

NCT01250925 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01250925 about?

NCT01250925 is a clinical study titled "Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface". The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across three lens care regimens in new contact lens wearers.

What is the current status of trial NCT01250925?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 94 participants. The study started on 2010-08. Estimated completion is 2012-07.

What interventions are being tested in trial NCT01250925?

The interventions under investigation include: ReNu MultiPlus® MultiPurpose Solution (DRUG), OPTI-FREE® RepleniSH® (DRUG), Clear Care® (DRUG).

Who is sponsoring clinical trial NCT01250925?

This trial is sponsored by Massachusetts Eye and Ear Infirmary, which has 73 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01250925's enrollment target sits among peer trials

94 871st of 2000 higher than 1,127 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT01250925, the US trial registry maintained by the National Library of Medicine. NCT01250925 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.