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Trial record 1 of 2 for:    "Atopic Keratoconjunctivitis" | "Cyclosporins"
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Long-term Topical Cyclosporine for Atopic Keratoconjunctivitis

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ClinicalTrials.gov Identifier: NCT00987467
Recruitment Status : Completed
First Posted : October 1, 2009
Results First Posted : October 8, 2013
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Atopic Keratoconjunctivitis
Intervention Drug: Cyclosporin 0.05% ophthalmic
Enrollment 12
Recruitment Details Patients were recruited from the PI's medical clinic.
Pre-assignment Details 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.
Arm/Group Title Cyclosporine
Hide Arm/Group Description

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

Period Title: Overall Study
Started 12
Completed 10
Not Completed 2
Reason Not Completed
Lost to Follow-up             2
Arm/Group Title Cyclosporine
Hide Arm/Group Description

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 Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
41  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
6
  50.0%
Male
6
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Ocular Symptoms and Signs Total Composite Score
Hide Description 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.
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Steroid Resistant/ Dependant AKC.
Hide Arm/Group Description:
Ten patients with significant AKC either steroid dependent or resistant who were having active inflammation were enrolled in this study.
Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: units on a scale
Baseline
29.1
(14 to 40)
8 weeks
4.7
(0 to 15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients With Steroid Resistant/ Dependant AKC.
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Corticosteroid Usage
Hide Description Number of flare-ups requiring topical steroid-use across all participants over the entire 12 month follow-up period
Time Frame Entire follow-up period (Approximately 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topical Steroid Resistant/Dependant AKC
Hide Arm/Group Description:
Patients with topical steroid resistant or dependant AKC were used for this study.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Total number of flare-up episodes
3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cyclosporine
Hide Arm/Group Description

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

All-Cause Mortality
Cyclosporine
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cyclosporine
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cyclosporine
Affected / at Risk (%)
Total   0/12 (0.00%) 
We were not able to have a control group and the treatment was not masked.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Esen Akpek, MD, Associate Professor of Ophthalmology, Wilmer Eye Institute
Organization: Johns Hopkins University, Wilmer Eye Institute
Phone: 410-955-5214
EMail: esakpek@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00987467     History of Changes
Other Study ID Numbers: NA_00010864
First Submitted: September 30, 2009
First Posted: October 1, 2009
Results First Submitted: April 15, 2013
Results First Posted: October 8, 2013
Last Update Posted: April 2, 2018