Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001731
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Treatment of Dry Eye Syndrome With Cyclosporin A Eye Drops
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Double-Masked Randomized Vehicle-Controlled Pilot Study of the Treatment of Keratoconjunctivitis Sicca With Topical Cyclosporin A 01 Emulsion
Status:
COMPLETED
Status Verified Date:
1999-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Sjogrens 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 01 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
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 Sjogrens 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 01 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
Detailed Description:
Dry eye syndrome also known as keratoconjunctivitis sicca or KCS is a disorder of the tear film leading to damage to the ocular surface and ocular discomfort In aqueous tear deficient dry eye there is inadequate tear production Patients with dry eye include those who have KCS and those with a more severe form of KCS associated with Sjogrens Syndrome SS In SS lymphocytic infiltration of the lacrimal gland leads to destruction of acinar structures and impaired glandular function Although most cases of KCS are not due to Sjogrens Syndrome lymphocytic infiltration of the lacrimal glands of non-Sjogrens KCS patients has been demonstrated and some authors suggest that age-related atrophic changes of the lacrimal gland may be secondary to a chronic progressive inflammatory process Several clinical studies have indicated that systemic or topical CsA improves some objective or subjective signs of KCS in patients with or without SS In this protocol patients with aqueous tear deficient KCS will be randomized to treatment with topical CsA 01 or the emulsion vehicle To determine the safety and efficacy of CsA 01 treatment in patients with KCS comprehensive ophthalmologic examinations and standardized symptom assessments will be performed In addition to determine the ability of topical CSA to alter ocular surface inflammation pre- and post-treatment conjunctival biopsy specimens will be analyzed for infiltrating lymphocytes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 98-EI-0032 | None | None | None |