A Double-Masked, Randomized, Vehicle-Controlled Pilot Study of the Treatment of Keratoconjunctivitis Sicca With Topical Cyclosporin A 0.1% Emulsion

Study start date: November 1, 1997

Diagnosis of CS with documented symptoms and signs (as required below) despite conventional management which may include artificial tears, gels and ointments, sympathomimetic agents and parasympathomimetic agents: Schirmer (without anesthesia) less than or equal to 8 mm/5 min in at least one eye; HOWEVER, if Schirmer (without anesthesia) is zero (0) mm, Schirmer with nasal stimulation greater than or equal to 3 mm/ 5 min in the same eye, OR; Schirmer (with anesthesia) less than or equal to 10 mm/ 5 min in at least one eye and sum of interpalpebral staining greater than or equal to 3+ or corneal staining greater than or equal to 1+ in the same eye. Able and willing to provide informed consent. Willingness and ability to meet followup requirements. Female patients of childbearing potential must use reliable forms of contraception during the study. A negative pregnancy test result in women of childbearing potential. Normal lid position and closure. The following topical (creams, ointments or patches) or systemic medications are allowed as long as the patient has been on a stable dose for at least 90 days before the baseline visit: Estrogen-progesterone, or other estrogen derivatives. If using concomitant medications, and the patient's condition is stable, the patient must agree to remain on a stable dose of his or her concomitant medications throughout the study period, or if the patient's condition is not stable, then they must agree not to use concomitant medications. Review of the instructions for use of concomitant medications during the study, prior to the eye examination, and agreement from the patient that they will comply with the instructions. A copy of the instructions must be given to the patient prior to enrollment. Patient must not have uncontrolled systemic disease (e.g., hypertension, diabetes) or the presence of any significant illness (e.g., serious gastrointestinal, renal, hepatic, endocrine, pulmonary, cardiac, neurologic disease, cancer, AIDS, or cerebral dysfunction) that could, in the judgment of the investigator, interfere with interpretation of the study results. Patients must not have used ophthalmic topical or systemic cyclosporine in the past 90 days. Patients must not have Schirmer readings less than 3 mm/5 min, without anesthesia, in both eyes after stimulation thereby indicating end stage lacrimal gland disease. Patient must not have active ocular infection or non-KCS ocular inflammation. Patient must not have a history of recurrent herpes keratitis or active disease within the last six months. Patient must not have corneal disorder or abnormality that effects corneal sensitivity or normal spreading of the tear film (except SPK). Patient must not have severe blepharitis or obvious inflammation of the lid margin which in the judgment of the investigator may interfere with the interpretation of the study results. No plug placement (laser, cautery, silicone, or collagen implant) within one month prior to the screening visit. No punctal occlusion performed during the study. Patient must not have a history of anterior segment surgery or trauma which could affect corneal sensitivity (e.g., cataract surgery or any surgery involving a limbal or corneal incision within the last 12 months). Patient must not have KCS secondary to the destruction of conjunctival goblet cells as occurs with vitamin A deficiency or scarring such as that with cicatricial pemphigoid, alkali burns, Stevens-Johnson syndrome, trachoma, or irradiation. Patients must not use Saligan or antihistamines more than 3 times a week.