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NCT01315574 · ClinicalTrials.gov registry record · Phase 4
Effects of Anti-Glaucoma Medications on the Ocular Surface
A Phase 4 study, sponsored by Massachusetts Eye and Ear Infirmary.
- Terminated
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
NCT01315574: Clinical Trial Phase 4 study, sponsored by Massachusetts Eye and Ear Infirmary.
NCT01315574 is a Phase 4 study that was terminated before completion, run by Massachusetts Eye and Ear Infirmary. The registered enrollment target is 14 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01315574, a Phase 4 study, was terminated before completion, sponsored by Massachusetts Eye and Ear Infirmary.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of the study is to compare the efficacy of FDA-approved Travoprost (Travatan Z) and Latanoprost (Xalatan)as anti-glaucoma treatment. Several studies indicate that glaucoma medications may be associated with decreased tear production and tear film break-up time (TBUT), and increased inflammatory cells in the conjunctiva (membrane lining of the eye lids and the covering of the eye) leading to dry eye. Normal tear film (coating of the eye) is continuous and blinking maintains the tear film continuity. If you keep your eyes open long enough without blinking, the tear film will start breaking up. Your eye will feel uncomfortable forcing you to blink. In patients with dry eyes, the tear film is unstable, and breaks up faster. Therefore the tear break up time in patients who have dry eyes is shorter. In this study, the investigators will be comparing the two previously mentioned FDA-approved eye drops Latanoprost and Travoprost. The difference between the two medications is a preservative called benzalkonium chloride (BAK). Latanoprost contains BAK while Travoprost does not. The investigators will be comparing the efficacy of each medication in lowering IOP as well as trying to track the density of immune cells across the corneal surface by taking photos of your eye. The investigators will also be assessing whether either drop leads to symptoms of dry eye by comparing results from ocular surface exam tests such as TBUT.
Primary Outcome
Applanation tonometry will be used to measure patients' intraocular pressure
Interventions
- DRUG Latanoprost
- DRUG Travoprost
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2011-02 |
| Est. Completion | 2013-12 |
| Phase | Phase 4 |
Why NCT01315574 stopped before completion
NCT01315574 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Latanoprost is the first listed.
NCT01315574 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01315574 about?
NCT01315574 is a clinical study titled "Effects of Anti-Glaucoma Medications on the Ocular Surface". The purpose of the study is to compare the efficacy of FDA-approved Travoprost (Travatan Z) and Latanoprost (Xalatan)as anti-glaucoma treatment. Several studies indicate that glaucoma medications may be associated with decreased tear production and tear film break-up time (TBUT), and increased infla...
What is the current status of trial NCT01315574?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2011-02. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01315574?
The interventions under investigation include: Latanoprost (DRUG), Travoprost (DRUG).
Who is sponsoring clinical trial NCT01315574?
This trial is sponsored by Massachusetts Eye and Ear Infirmary, which has 73 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01315574's enrollment target sits among peer trials
14 1901st of 2000 higher than 91 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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