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Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy (IMPACT)

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ClinicalTrials.gov Identifier: NCT02121847
Recruitment Status : Completed
First Posted : April 24, 2014
Results First Posted : April 25, 2016
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
This study will evaluate the safety and efficacy of cyclosporine 0.05% ophthalmic emulsion (Restasis®) in patients with dry eye disease.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: cyclosporine 0.05% ophthalmic emulsion Drug: carboxymethylcellulose-based lubricant eye drops Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : April 3, 2014
Actual Primary Completion Date : September 23, 2014
Actual Study Completion Date : September 23, 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: cyclosporine 0.05% ophthalmic emulsion
Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
 Drug: cyclosporine 0.05% ophthalmic emulsion
Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily for 6 months.
Other Name: Restasis®

Drug: carboxymethylcellulose-based lubricant eye drops
Carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
Other Name: Refresh OPTIVE® Advanced


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Total Corneal Staining Score With Fluorescein in the Worse Eye [ Time Frame: Baseline, Month 6 ]
    Total corneal staining with fluorescein is measured in the worse eye utilizing the Ora CalibraTM Corneal Flourescein Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).

  2. Change From Baseline in Total Conjunctival Staining Score With Fluorescein in the Worse Eye [ Time Frame: Baseline, Month 6 ]
    Total conjunctival staining with fluorescein is measured in the worse eye utilizing the Ora CalibraTM Conjunctiva Flourescein Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).

  3. Change From Baseline in Total Corneal Staining Score With Lissamine Green in the Worse Eye [ Time Frame: Baseline, Month 6 ]
    Total corneal staining with lissamine green is measured in the worse eye utilizing the Ora CalibraTM Corneal Lissamine Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).

  4. Change From Baseline in Total Conjunctival Staining Score With Lissamine Green in the Worse Eye [ Time Frame: Baseline, Month 6 ]
    Total conjunctival staining with lissamine is measured in the worse eye utilizing the Ora CalibraTM Conjunctiva Lissamine Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).

  5. Change From Baseline in Reading on the Ocular Surface Disease Index (OSDI) [ Time Frame: Baseline, Month 6 ]
    The OSDI consists of 12 questions measuring the presence of ocular symptoms. The reading question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The reading score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.

  6. Change From Baseline in Driving at Night on the OSDI [ Time Frame: Baseline, Month 6 ]
    The OSDI consists of 12 questions measuring the presence of ocular symptoms. The driving at night question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The driving at night score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.

  7. Change From Baseline in Working With a Computer or Bank Machine on the OSDI [ Time Frame: Baseline, Month 6 ]
    The OSDI consists of 12 questions measuring the presence of ocular symptoms. The working with a computer or bank machine question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The working with a computer or bank machine score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.

  8. Change From Baseline in Watching TV on the OSDI [ Time Frame: Baseline, Month 6 ]
    The OSDI consists of 12 questions measuring the presence of ocular symptoms. The watching TV question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The watching TV score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.

  9. Change From Baseline in Reading Rate [ Time Frame: Baseline, Month 6 ]
    Reading speed is assessed as the number of words read correctly in 2 minutes.

  10. Change From Baseline in Words Read Incorrectly [ Time Frame: Baseline, Month 6 ]
    The numbers of words read incorrectly are counted in 2 minutes. A positive change from baseline indicates a worsening, and a negative change from baseline indicates an improvement.

  11. Change From Baseline in Font Size [ Time Frame: Baseline, Month 6 ]
    The minimum font (letter) size read correctly is assessed. Smaller font size indicates better ability. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.


Secondary Outcome Measures :
  1. Change From Baseline in OSDI [ Time Frame: Baseline, Month 6 ]
    The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.

  2. Change From Baseline in Ocular Discomfort on a 4-point Scale [ Time Frame: Baseline, Month 6 ]
    Ocular discomfort is assessed on a 4-point scale where 0=no discomfort and 3=most discomfort. A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.

  3. Change From Baseline in Tear Film Break-up Time in the Worse Eye [ Time Frame: Baseline, Month 6 ]
    TFBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement and a negative number change from baseline indicates a worsening.

  4. Change From Baseline in the Interblink Interval in the Worse Eye [ Time Frame: Baseline, Month 6 ]
    The interblink interval measures the time (seconds) between blinks in the worse eye. A positive number change from baseline indicates a worsening (more frequent blinks) and a negative number change from baseline (less frequent blinks) indicates an improvement.

  5. Change From Baseline in Conjunctival Redness in the Worse Eye [ Time Frame: Baseline, Month 6 ]
    Conjunctival redness is scored in the worse eye on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of dry eye in both eyes
  • Willing to use eye drops for dry eye symptoms

Exclusion Criteria:

  • Anticipate wearing contact lenses during the study
  • Laser-assisted in situ keratomileusis (LASIK) surgery within the past 12 months
  • Any ocular and/or lid surgeries within the past 6 months
  • Cataract surgery in either eye
  • Current or anticipated use of temporary punctal plugs during the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02121847


Locations
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United States, Massachusetts
Andover, Massachusetts, United States
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Publications:

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02121847    
Other Study ID Numbers: GMA-RES-014-001
First Posted: April 24, 2014    Key Record Dates
Results First Posted: April 25, 2016
Last Update Posted: April 18, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Cyclosporine
Carboxymethylcellulose Sodium
Ophthalmic Solutions
Lubricant Eye Drops
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Pharmaceutical Solutions
Laxatives
Gastrointestinal Agents