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Trial record 2 of 2 for:    "Atopic Keratoconjunctivitis" | "Cyclosporins"

Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis

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ClinicalTrials.gov Identifier: NCT00884585
Recruitment Status : Completed
First Posted : April 21, 2009
Results First Posted : November 5, 2012
Last Update Posted : November 5, 2012
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Atopic Conjunctivitis
Interventions Drug: Cyclosporine Vehicle
Drug: Cyclosporine 0.010%
Enrollment 176
Recruitment Details  
Pre-assignment Details Per protocol defined pre-specified criteria, both eyes could qualify for treatment. However, only one eye was designated as the study eye.
Arm/Group Title Cyclosporine Ophthalmic Solution (COS) Followed by COS Placebo Followed by COS
Hide Arm/Group Description Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day. Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day.
Period Title: Double-Masked Phase (Day 1-Month 3)
Started 89 87
Completed 79 83 [1]
Not Completed 10 4
[1]
All placebo patients who completed the double-masked phase received COS in the open-label phase.
Period Title: Open-Label Phase (Months 3-9)
Started 162 [1] 0 [2]
Completed 147 0
Not Completed 15 0
[1]
All patients who completed the double-masked phase received COS in the open-label phase.
[2]
All placebo patients who completed the double-masked phase received COS in the open-label phase.
Period Title: Open-Label Maintenance (Months 9-12)
Started 147 0
Completed 144 0
Not Completed 3 0
Arm/Group Title Cyclosporine Ophthalmic Solution (COS) Followed by COS Placebo Followed by COS Total
Hide Arm/Group Description Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day. Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day. Total of all reporting groups
Overall Number of Baseline Participants 89 87 176
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 89 participants 87 participants 176 participants
<18 years 7 8 15
18 to <30 years 15 13 28
30 to <50 years 32 38 70
50 to <65 years 27 22 49
>=65 years 8 6 14
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 87 participants 176 participants
Female
46
  51.7%
39
  44.8%
85
  48.3%
Male
43
  48.3%
48
  55.2%
91
  51.7%
1.Primary Outcome
Title Percentage of Treatment Responders
Hide Description Treatment responders are defined as patients with a ≥ 1 grade improvement from baseline in punctate corneal staining score and a ≥ 4 grade improvement from baseline in composite symptom score in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 (0 is ≤2 dots and 5 is >316 dots (approximately) or ulcer/erosion). The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). The composite symptom score (0 to 15) is the sum of 5 symptoms (each symptom is assessed on a scale of 0=absent to 3=severe).
Time Frame Baseline, Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat: all randomized patients
Arm/Group Title Cyclosporine Ophthalmic Solution (COS) Followed by COS Placebo
Hide Arm/Group Description:
Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
Overall Number of Participants Analyzed 89 87
Measure Type: Number
Unit of Measure: Percentage of Patients
21.3 17.2
2.Secondary Outcome
Title Percentage of Punctate Corneal Staining Responders
Hide Description Punctate corneal staining responders defined as patients achieving a punctate corneal staining score of 0 or 1 in the study eye. Punctate corneal staining is assessed on a scale of 0 to 5 where 0 is ≤2 dots, 1 is >2 dots but ≤ 10 dots, 2 is > 10 dots but ≤ 32 dots, 3 is > 32 dots but ≤ 100 dots (approximately), 4 is > 100 dots (approximately) but ≤ 316 dots (approximately), and 5 is >316 dots (approximately) or ulcer/erosion.
Time Frame Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat: all randomized patients
Arm/Group Title Cyclosporine Ophthalmic Solution (COS) Followed by COS Placebo
Hide Arm/Group Description:
Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
Overall Number of Participants Analyzed 89 87
Measure Type: Number
Unit of Measure: Percentage of Patients
24.7 23.0
3.Secondary Outcome
Title Percentage of Patients With an Improvement in the Composite Symptom Score
Hide Description Composite symptom score improvement is defined as a 4 or more grade decrease from baseline in composite symptom score in the study eye. The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). Each of the 5 symptoms is assessed on a scale of 0=absent to 3=severe. The composite symptom score is the sum of all 5 individual symptom scores, where 0 is no symptoms and 15 is the most severe symptoms.
Time Frame Baseline, Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat: all randomized patients
Arm/Group Title Cyclosporine Ophthalmic Solution (COS) Followed by COS Placebo
Hide Arm/Group Description:
Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
Overall Number of Participants Analyzed 89 87
Measure Type: Number
Unit of Measure: Percentage of Patients
30.3 28.7
4.Secondary Outcome
Title Percentage of Patients With an Improvement in the Punctate Corneal Staining Score
Hide Description Punctate corneal staining improvement is defined as a 1 or more grade decrease from baseline in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 where 0 is ≤2 dots, 1 is >2 dots but ≤ 10 dots, 2 is > 10 dots but ≤ 32 dots, 3 is > 32 dots but ≤ 100 dots (approximately), 4 is > 100 dots (approximately) but ≤ 316 dots (approximately), and 5 is >316 dots (approximately) or ulcer/erosion.
Time Frame Baseline, Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclosporine Ophthalmic Solution (COS) Followed by COS Placebo
Hide Arm/Group Description:
Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
Overall Number of Participants Analyzed 89 87
Measure Type: Number
Unit of Measure: Percentage of Patients
42.7 42.5
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety Population was used for all adverse event (AE)/serious adverse event (SAE) reporting. All patients in the safety population received at least 1 dose of study medication.
 
Arm/Group Title Cyclosporine Ophthalmic Solution (COS) Followed by COS Placebo
Hide Arm/Group Description Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day. Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
All-Cause Mortality
Cyclosporine Ophthalmic Solution (COS) Followed by COS Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cyclosporine Ophthalmic Solution (COS) Followed by COS Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   11/171 (6.43%)   3/87 (3.45%) 
Gastrointestinal disorders     
Abdominal Hernia  1  1/171 (0.58%)  0/87 (0.00%) 
Immune system disorders     
Anaphylactic Shock  1  0/171 (0.00%)  1/87 (1.15%) 
Infections and infestations     
Pneumonia  1  1/171 (0.58%)  0/87 (0.00%) 
Infectious Mononucleosis  1  1/171 (0.58%)  0/87 (0.00%) 
Herpes Zoster * 1  1/171 (0.58%)  0/87 (0.00%) 
Injury, poisoning and procedural complications     
Forearm Fracture  1  1/171 (0.58%)  0/87 (0.00%) 
Joint Injury * 1  1/171 (0.58%)  0/87 (0.00%) 
Investigations     
Prostatic Specific Antigen Increased  1  1/171 (0.58%)  0/87 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis * 1  1/171 (0.58%)  0/87 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast Cancer  1  0/171 (0.00%)  1/87 (1.15%) 
Psychiatric disorders     
Depression * 1  1/171 (0.58%)  0/87 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  0/171 (0.00%)  1/87 (1.15%) 
Skin and subcutaneous tissue disorders     
Dermatitis Atopic * 1  1/171 (0.58%)  0/87 (0.00%) 
Vascular disorders     
Hypertension  1  1/171 (0.58%)  0/87 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cyclosporine Ophthalmic Solution (COS) Followed by COS Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   44/171 (25.73%)   16/87 (18.39%) 
Eye disorders     
Allergic Keratitis  1  24/171 (14.04%)  10/87 (11.49%) 
Blepharitis  1  10/171 (5.85%)  3/87 (3.45%) 
Punctate Keratitis  1  10/171 (5.85%)  3/87 (3.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00884585     History of Changes
Other Study ID Numbers: 192371-016
First Submitted: April 17, 2009
First Posted: April 21, 2009
Results First Submitted: September 27, 2012
Results First Posted: November 5, 2012
Last Update Posted: November 5, 2012