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NCT03848221 · ClinicalTrials.gov registry record · Phase 4
Direct Application of Systane Complete to Contact Lenses
A Phase 4 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 4
- Development phase
- 73
- Enrollment target
NCT03848221: Completed Phase 4 study, sponsored by University of Alabama at Birmingham.
NCT03848221 is a Phase 4 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 73 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03848221, a Phase 4 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 73 participants
- Enrollment target
Study Summary
A common first line treatment for patients with dryness symptoms or contact lens discomfort is the application of artificial tears or rewetting drops, respectively. Rewetting drops are specifically formulated for use with contact lenses while artificial tears are indicated for dry eye. Modern rewetting drops and artificial tears have similar formulations with similar preservatives, preservatives that have been shown to be compatible with contact lenses. While rewetting drops and artificial tears are regulated under different U.S. Food \& Drug Administration policies, artificial tears are not specifically indicated for direct use with contact lenses. Nevertheless, clinicians commonly prescribe artificial tears to contact lens wearers likely because newer formulations of artificial tear have the potential to outperform available rewetting drops. The safety and efficacy of using artificial tears with contact lenses for the treatment of discomfort is supported by Caffery and Josephson and Ozkan and Papas who found that artificial tears significantly reduces dryness symptoms in contact lens wearers. Thus, the purpose of this study is to test the safety of directly applying a new artificial tear, Systane Complete, to the contact lens wearing eye and its ability to alleviate symptoms while wearing contact lenses during the day.
Primary Outcome
The Corneal Staining Scores are measured by the BHVI grading scale. The grading scales are a quick reference to the key signs associated with contact lens related inflammation and infection. Used as a reference tool in the clinic, they provide a guide for determining how much normal ocular appearance has changed in a patient, and can help inform clinical management decisions. The range of the scores are: 0-4 in five regions (total sum score = 20). A lower score indicates a better outcome.
Interventions
- DRUG Systane Complete
- DRUG Sensitive Eyes Rewetting Drops
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2019-05-28 |
| Est. Completion | 2019-10-20 |
| Phase | Phase 4 |
What the finished NCT03848221 record still lists
NCT03848221 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Systane Complete is the first listed.
NCT03848221 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03848221 about?
NCT03848221 is a clinical study titled "Direct Application of Systane Complete to Contact Lenses". A common first line treatment for patients with dryness symptoms or contact lens discomfort is the application of artificial tears or rewetting drops, respectively. Rewetting drops are specifically formulated for use with contact lenses while artificial tears are indicated for dry eye. Modern rewett...
What is the current status of trial NCT03848221?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 73 participants. The study started on 2019-05-28. Estimated completion is 2019-10-20.
What interventions are being tested in trial NCT03848221?
The interventions under investigation include: Systane Complete (DRUG), Sensitive Eyes Rewetting Drops (DRUG).
Who is sponsoring clinical trial NCT03848221?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03848221's enrollment target sits among peer trials
73 1033rd of 2000 higher than 966 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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