Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy

NCT02121847 | Completed Phase 4 Results

• 1 other identifier: GMA-RES-014-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Change From Baseline in Reading Rate

  Reading speed is assessed as the number of words read correctly in 2 minutes.

  Baseline, Month 6

• 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

• 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 Outcomes (5)

• Change From Baseline in OSDI

  Baseline, Month 6

• Change From Baseline in Ocular Discomfort on a 4-point Scale

  Baseline, Month 6

• Change From Baseline in Tear Film Break-up Time in the Worse Eye

  Baseline, Month 6

• Change From Baseline in the Interblink Interval in the Worse Eye

  Baseline, Month 6

• Change From Baseline in Conjunctival Redness in the Worse Eye

  Baseline, Month 6

Study Arms (1)

cyclosporine 0.05% ophthalmic emulsion

EXPERIMENTAL

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; Drug: carboxymethylcellulose-based lubricant eye drops

Interventions

cyclosporine 0.05% ophthalmic emulsion DRUG

Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily for 6 months.

Also known as: Restasis®

cyclosporine 0.05% ophthalmic emulsion

carboxymethylcellulose-based lubricant eye drops DRUG

Carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.

Also known as: Refresh OPTIVE® Advanced

cyclosporine 0.05% ophthalmic emulsion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Andover, Massachusetts, United States

Location

Related 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.

  PMID: 27257373 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporine; Cyclosporins

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Vice President Medical Affairs,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 24, 2014
• Study Start: April 3, 2014
• Primary Completion: September 23, 2014
• Study Completion: September 23, 2014
• Last Updated: April 18, 2019
• Results First Posted: April 25, 2016

Record last verified: 2019-04

Locations

US (1)