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Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye

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ClinicalTrials.gov Identifier: NCT01319773
Recruitment Status : Completed
First Posted : March 22, 2011
Results First Posted : March 2, 2012
Last Update Posted : September 7, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor)
Condition Dry Eye Syndromes
Interventions Drug: cyclosporine ophthalmic emulsion Formulation A
Drug: cyclosporine ophthalmic emulsion Formulation B
Drug: cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05%
Drug: cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05%
Drug: cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B
Enrollment 44
Recruitment Details  
Pre-assignment Details This study included a parallel-group phase (PGP) and a paired-eye phase (PEP). The paired-eye phase of the study began after the parallel-group phase completed. The parallel-group phase enrolled healthy volunteers and the paired-eye phase enrolled patients with dry eye symptoms.
Arm/Group Title PGP: Cyclosporine Formulation A PGP: Cyclosporine Formulation B PEP: Cyclosporine Formulation A and Cyclosporine 0.05% PEP: Cyclosporine Formulation B and Cyclosporine 0.05% PEP: Cyclosporine Formulation A and Cyclosporine Formulation B
Hide Arm/Group Description Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A PGP: cyclosporine ophthalmic emulsion Formulation B Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05% PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05% PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
Period Title: Overall Study
Started 10 10 8 8 8
Completed 10 10 8 8 8
Not Completed 0 0 0 0 0
Arm/Group Title PGP: Cyclosporine Formulation A PGP: Cyclosporine Formulation B PEP: Cyclosporine Formulation A and Cyclosporine 0.05% PEP: Cyclosporine Formulation B and Cyclosporine 0.05% PEP: Cyclosporine Formulation A and Cyclosporine Formulation B Total
Hide Arm/Group Description Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A PGP: cyclosporine ophthalmic emulsion Formulation B Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05% PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05% PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B Total of all reporting groups
Overall Number of Baseline Participants 10 10 8 8 8 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 8 participants 8 participants 8 participants 44 participants
18 to 30 years 8 8 1 1 1 19
> 30 to 40 years 2 2 0 1 0 5
> 40 years 0 0 7 6 7 20
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 8 participants 8 participants 8 participants 44 participants
Female
3
  30.0%
5
  50.0%
5
  62.5%
5
  62.5%
8
 100.0%
26
  59.1%
Male
7
  70.0%
5
  50.0%
3
  37.5%
3
  37.5%
0
   0.0%
18
  40.9%
1.Primary Outcome
Title Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP)
Hide Description Concentration of cyclosporine measured in blood at Day 1 of the parallel-group phase (PGP). Blood samples were collected up to 3 hours post-dose and concentrations of cyclosporine were measured.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: All randomized subjects who were treated with at least 1 dose of study medication.
Arm/Group Title Cyclosporine Formulation A Cyclosporine Formulation B
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: Nanogram/milliliter (ng/mL)
Time = pre-dose NA [1]  NA [1] 
Time = 0.5 hours NA [1]  NA [1] 
Time = 1 hour NA [1]  NA [1] 
Time = 3 hours NA [1]  NA [1] 
[1]
Below limit of quantification
2.Secondary Outcome
Title Number of Subjects Who Reported Ocular Symptoms During the Parallel-Group Phase (PGP)
Hide Description Number of subjects who reported ocular symptoms of any severity during the parallel-group phase (PGP) of the study. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild,+1=mild, +2=moderate, and +3=severe).
Time Frame 3 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol: All randomized subjects who received their assigned study medication and closely followed the protocol.
Arm/Group Title Cyclosporine Formulation A Cyclosporine Formulation B
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: Number of Subjects
3 1
3.Secondary Outcome
Title Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1
Hide Description Number of eyes with ocular symptoms of any severity, post-dose in the paired-eye phase (PEP) at Day 1. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild, +1=mild, +2=moderate, and +3=severe).
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol: All randomized subjects who received their assigned study medication and closely followed the protocol.
Arm/Group Title Cyclosporine Formulation A Cyclosporine Formulation B Cyclosporine 0.05%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 8 8 8
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
16 16 16
Measure Type: Number
Unit of Measure: Number of Eyes
Blurring 2 1 1
Foreign Body Sensation 0 0 0
Pain 0 1 0
Burning/Stinging 3 2 2
Tearing 1 2 3
Itching 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
 
Arm/Group Title PGP: Cyclosporine Formulation A PGP: Cyclosporine Formulation B PEP: Cyclosporine Formulation A and Cyclosporine 0.05% PEP: Cyclosporine Formulation B and Cyclosporine 0.05% PEP: Cyclosporine Formulation A and Cyclosporine Formulation B
Hide Arm/Group Description Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A PGP: cyclosporine ophthalmic emulsion Formulation B Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05% PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05% PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
All-Cause Mortality
PGP: Cyclosporine Formulation A PGP: Cyclosporine Formulation B PEP: Cyclosporine Formulation A and Cyclosporine 0.05% PEP: Cyclosporine Formulation B and Cyclosporine 0.05% PEP: Cyclosporine Formulation A and Cyclosporine Formulation B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PGP: Cyclosporine Formulation A PGP: Cyclosporine Formulation B PEP: Cyclosporine Formulation A and Cyclosporine 0.05% PEP: Cyclosporine Formulation B and Cyclosporine 0.05% PEP: Cyclosporine Formulation A and Cyclosporine Formulation B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PGP: Cyclosporine Formulation A PGP: Cyclosporine Formulation B PEP: Cyclosporine Formulation A and Cyclosporine 0.05% PEP: Cyclosporine Formulation B and Cyclosporine 0.05% PEP: Cyclosporine Formulation A and Cyclosporine Formulation B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/10 (40.00%)   2/10 (20.00%)   5/8 (62.50%)   8/8 (100.00%)   8/8 (100.00%) 
Eye disorders           
Punctate Keratitis  1  1/10 (10.00%)  2/10 (20.00%)  2/8 (25.00%)  1/8 (12.50%)  0/8 (0.00%) 
Conjunctival Hyperaemia  1  1/10 (10.00%)  0/10 (0.00%)  4/8 (50.00%)  4/8 (50.00%)  6/8 (75.00%) 
Abnormal Sensation in Eye * 1  0/10 (0.00%)  0/10 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%) 
Dry Eye * 1  0/10 (0.00%)  0/10 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%) 
Eyelid Irritation * 1  0/10 (0.00%)  0/10 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%) 
Eye Irritation * 1  0/10 (0.00%)  0/10 (0.00%)  0/8 (0.00%)  5/8 (62.50%)  2/8 (25.00%) 
Eye Pain * 1  0/10 (0.00%)  0/10 (0.00%)  0/8 (0.00%)  3/8 (37.50%)  1/8 (12.50%) 
Eye Pruritus * 1  0/10 (0.00%)  0/10 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  3/8 (37.50%) 
Lacrimation Increased * 1  0/10 (0.00%)  0/10 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  1/8 (12.50%) 
Vision Blurred * 1  0/10 (0.00%)  0/10 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  2/8 (25.00%) 
Eye Discharge * 1  0/10 (0.00%)  0/10 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%) 
Foreign Body Sensation in Eyes * 1  0/10 (0.00%)  0/10 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Photophobia * 1  0/10 (0.00%)  0/10 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Nervous system disorders           
Headache * 1  2/10 (20.00%)  0/10 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Dysguesia * 1  0/10 (0.00%)  0/10 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
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
Name/Title: Therapeutic Area Head
Organization: Allergan, Inc.
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01319773     History of Changes
Other Study ID Numbers: 192371-021
First Submitted: March 18, 2011
First Posted: March 22, 2011
Results First Submitted: January 31, 2012
Results First Posted: March 2, 2012
Last Update Posted: September 7, 2015