Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy

Dry Eye Syndromes Clinical Trial

— IMPACT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121847
• Other study ID #: GMA-RES-014-001
• Status: Completed
• Phase: Phase 4
• Start date: April 3, 2014
• Est. completion date: September 23, 2014

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 23, 2014
• Est. primary completion date: September 23, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• cyclosporine 0.05% ophthalmic emulsion
Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily for 6 months.
• carboxymethylcellulose-based lubricant eye drops
Carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

References & Publications (1)

Stonecipher KG, Torkildsen GL, Ousler GW 3rd, Morris S, Villanueva L, Hollander DA. The IMPACT study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye. Clin Ophthalmol. 2016 May 13;10:887-95. doi: 10.2147/OPTH.S101627. eCollection 2016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Total Corneal Staining Score With Fluorescein in the Worse Eye	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).	Baseline, Month 6
Primary	Change From Baseline in Total Conjunctival Staining Score With Fluorescein in the Worse Eye	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).	Baseline, Month 6
Primary	Change From Baseline in Total Corneal Staining Score With Lissamine Green in the Worse Eye	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).	Baseline, Month 6
Primary	Change From Baseline in Total Conjunctival Staining Score With Lissamine Green in the Worse Eye	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).	Baseline, Month 6
Primary	Change From Baseline in Reading on the Ocular Surface Disease Index (OSDI)	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.	Baseline, Month 6
Primary	Change From Baseline in Driving at Night on the OSDI	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.	Baseline, Month 6
Primary	Change From Baseline in Working With a Computer or Bank Machine on the OSDI	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.	Baseline, Month 6
Primary	Change From Baseline in Watching TV on the OSDI	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.	Baseline, Month 6
Primary	Change From Baseline in Reading Rate	Reading speed is assessed as the number of words read correctly in 2 minutes.	Baseline, Month 6
Primary	Change From Baseline in Words Read Incorrectly	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.	Baseline, Month 6
Primary	Change From Baseline in Font Size	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.	Baseline, Month 6
Secondary	Change From Baseline in OSDI	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.	Baseline, Month 6
Secondary	Change From Baseline in Ocular Discomfort on a 4-point Scale	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.	Baseline, Month 6
Secondary	Change From Baseline in Tear Film Break-up Time in the Worse Eye	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.	Baseline, Month 6
Secondary	Change From Baseline in the Interblink Interval in the Worse Eye	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.	Baseline, Month 6
Secondary	Change From Baseline in Conjunctival Redness in the Worse Eye	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.	Baseline, Month 6