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NCT00001731 · ClinicalTrials.gov registry record · Phase 2

Treatment of Dry Eye Syndrome With Cyclosporin A Eye Drops

A Phase 2 study of Sjogren's Syndrome and Keratoconjunctivitis Sicca, sponsored by National Eye Institute (NEI).

Completed
Registry status
Phase 2
Development phase
30
Enrollment target
1
Study location

NCT00001731 is a Phase 2 study of Sjogren's Syndrome and Keratoconjunctivitis Sicca that has completed, run by National Eye Institute (NEI). The registered enrollment target is 30 participants, below the 287-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00001731, a Phase 2 study of Sjogren's Syndrome and Keratoconjunctivitis Sicca, has completed, sponsored by National Eye Institute (NEI).

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

This study will examine whether cyclosporin A eye drops alleviate dry eye syndrome, a disorder of tear deficiency or excessive tear evaporation. The condition damages the surface of the eye and causes discomfort. Age-related dry eye syndrome may result from a problem with the immune system in which cells called lymphocytes infiltrate the tear glands and cause a chronic, progressive inflammatory process. Previous studies suggest that cyclosporin A may increase tear production or decrease inflammation on the surface of the eye, or both, improving dry eye symptoms. Patients in the study will undergo a complete eye examination, and a small tear sample will be collected to study tear consistency and composition. A small amount of conjunctiva (the clear, thin covering of the eye lining the eyelids and eyeball) will be removed to study substances in it that might provide information on what causes dry eye. A blood sample also will be taken to look for antibodies found in patients with Sjogren's syndrome, a disorder characterized by dryness of the mouth, eyes and other mucous membranes. Patients will also fill out forms providing information on the extent to which their dry eyes bother them. Patients will be randomly divided into two treatment groups: one will take a cyclosporin 0.1% eye drop emulsion; the other will take the emulsion vehicle alone-that is, the same drops but without the active ingredient cyclosporin. Both groups will take one drop in each eye 4 times a day for 2 months. Neither the patients nor the doctors will know which patients are receiving which medication until the study ends. All patients will also be given artificial teardrops to use for comfort if needed.

Interventions

  • DRUG Cyclosporin A

Study Locations (1)

Maryland

  • National Eye Institute (NEI) - Bethesda

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 1997-11
Est. Completion 2000-10
Phase Phase 2

Sponsor

National Eye Institute (NEI)

221 total trials

What the Registry Record Tells You About NCT00001731

The ClinicalTrials.gov registry entry for NCT00001731 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 287-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (90% lower). The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Sjogren's Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Cyclosporin A is the first listed.

NCT00001731 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00001731 about?

NCT00001731 is a clinical study titled "Treatment of Dry Eye Syndrome With Cyclosporin A Eye Drops". This study will examine whether cyclosporin A eye drops alleviate dry eye syndrome, a disorder of tear deficiency or excessive tear evaporation. The condition damages the surface of the eye and causes discomfort. Age-related dry eye syndrome may result from a problem with the immune system in which...

What is the current status of trial NCT00001731?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 1997-11. Estimated completion is 2000-10.

What conditions does trial NCT00001731 study?

This clinical trial studies the following conditions: Sjogren's Syndrome, Keratoconjunctivitis Sicca.

What interventions are being tested in trial NCT00001731?

The interventions under investigation include: Cyclosporin A (DRUG).

Who is sponsoring clinical trial NCT00001731?

This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00001731 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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