Trial Outcomes & Findings for Long-term Topical Cyclosporine for Atopic Keratoconjunctivitis (NCT NCT00987467)

Results Overview

Symptoms (itching, tearing, discomfort, discharge, photophobia) and signs (Bulbar conjunctival hyperemia, upper tarsal conjunctival papillae, punctate keratitis, corneal neovascularization, cicatrizing conjunctivitis, and blepharitis) evaluated on a 4 point scale of 0-3, with a minimum symptom score of 0- maximum 15, and sign score minimum 0- maximum 18. These scores are combined to yeild a total composite score of signs and symptoms of minimum 0-maximum 33. The highest score would indicate the most severe case of Atopic Keratoconjunctivitis (AKC). The composite score is reported.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

Baseline and 8 weeks

Results posted on

2018-04-02

Participant Flow

Patients were recruited from the PI's medical clinic.

Patients started with a conjunctival biopsy prior to enrolling in the study. Following biopsy, for one week, patients were discontinued on antiinflammatories and given only topical antibiotic prior to the study treatment of topical cyclosporin.

Participant milestones

Participant milestones
Measure	Cyclosporine Patients with atopic keratoconjunctivitis were started with cyclosporine 0.05% ophthalmic eye drops, starting with 1 drop in both eyes 6 times daily for first month, followed by 1 drop in both eyes 4 times daily for the following month, then adjusted by clinician as needed for appropriate disease control. Cyclosporins : Cyclosporine 0.05% ophthalmic solution, 6 times in both eyes daily for first month, then 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Cyclosporine Patients with atopic keratoconjunctivitis were started with cyclosporine 0.05% ophthalmic eye drops, starting with 1 drop in both eyes 6 times daily for first month, followed by 1 drop in both eyes 4 times daily for the following month, then adjusted by clinician as needed for appropriate disease control. Cyclosporins : Cyclosporine 0.05% ophthalmic solution, 6 times in both eyes daily for first month, then 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator
Overall Study Lost to Follow-up	2

Baseline Characteristics

Long-term Topical Cyclosporine for Atopic Keratoconjunctivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cyclosporine n=12 Participants Patients with atopic keratoconjunctivitis were started with cyclosporine 0.05% ophthalmic eye drops, starting with 1 drop in both eyes 6 times daily for first month, followed by 1 drop in both eyes 4 times daily for the following month, then adjusted by clinician as needed for appropriate disease control. Cyclosporins : Cyclosporine 0.05% ophthalmic solution, 6 times in both eyes daily for first month, then 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Symptoms (itching, tearing, discomfort, discharge, photophobia) and signs (Bulbar conjunctival hyperemia, upper tarsal conjunctival papillae, punctate keratitis, corneal neovascularization, cicatrizing conjunctivitis, and blepharitis) evaluated on a 4 point scale of 0-3, with a minimum symptom score of 0- maximum 15, and sign score minimum 0- maximum 18. These scores are combined to yeild a total composite score of signs and symptoms of minimum 0-maximum 33. The highest score would indicate the most severe case of Atopic Keratoconjunctivitis (AKC). The composite score is reported.

Outcome measures

Outcome measures
Measure	Patients With Steroid Resistant/ Dependant AKC. n=10 Participants Ten patients with significant AKC either steroid dependent or resistant who were having active inflammation were enrolled in this study.
Ocular Symptoms and Signs Total Composite Score Baseline	29.1 units on a scale Interval 14.0 to 40.0
Ocular Symptoms and Signs Total Composite Score 8 weeks	4.7 units on a scale Interval 0.0 to 15.0

SECONDARY outcome

Timeframe: Entire follow-up period (Approximately 12 months)

Number of flare-ups requiring topical steroid-use across all participants over the entire 12 month follow-up period

Outcome measures

Outcome measures
Measure	Patients With Steroid Resistant/ Dependant AKC. n=10 Participants Ten patients with significant AKC either steroid dependent or resistant who were having active inflammation were enrolled in this study.
Corticosteroid Usage	3 Total number of flare-up episodes

Adverse Events

Cyclosporine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Esen Akpek, MD, Associate Professor of Ophthalmology, Wilmer Eye Institute

Johns Hopkins University, Wilmer Eye Institute

Phone: 410-955-5214

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place