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Treatment of Dry Eye Syndrome With Cyclosporin A Eye Drops
NCT00001731 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG Cyclosporin A
Study Locations (1)
Maryland
- National Eye Institute (NEI) — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 1997-11 |
| Est. Completion | 2000-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001731
The ClinicalTrials.gov registry entry for NCT00001731 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 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 214 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT00001731 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00001731?
The interventions under investigation include: Cyclosporin A (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00001731?
This trial is sponsored by National Eye Institute (NEI), which has 214 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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