Evaluation of Maintaining Visual Performance in Participants Who Engage in Electronic Visual Tasking While Using Restasis®

NCT02554981 | Completed Phase 4 Results

• 1 other identifier: MA-RES-015-001
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief Summary

This study will evaluate the efficacy of Restasis® in participants with dry eye disease who engage in electronic visual tasking.

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (10)

• Change From Baseline in the Total Corneal Staining Score With Fluorescein in the Worse Eye

  Total corneal staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). 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). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).

  Baseline, Month 6

• Change From Baseline in the Total Conjunctival Staining Score With Fluorescein in the Worse Eye

  Total conjunctival staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). 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). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).

  Baseline, Month 6

• Change From Baseline in the Central Region Staining Score With Fluorescein in the Worse Eye

  Staining with fluorescein in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).

  Baseline, Month 6

• Change From Baseline in the Total Corneal Staining Score With Lissamine Green in the Worse Eye

  Total corneal staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). 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). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).

  Baseline, Month 6

• Change From Baseline in the Total Conjunctival Staining Score With Lissamine Green in the Worse Eye

  Total conjunctival staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). 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). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).

  Baseline, Month 6

• Change From Baseline in the Central Region Staining Score With Lissamine Green in the Worse Eye

  Staining with lissamine green in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).

  Baseline, Month 6

• Change From Baseline in Font Size

  The minimum font (letter) size read correctly was assessed. Smaller font size (less points) indicates better ability. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening.

  Baseline, Month 6

• Change From Baseline in Words Read Incorrectly

  The numbers of words read incorrectly are counted. A positive change from Baseline indicates a worsening (more words read incorrectly) and a negative change from Baseline indicates an improvement.

  Baseline, Month 6

• Change From Baseline in Time to Read Passage

  The time to read passage (selected portion of text ) in seconds was assessed. A negative change from Baseline indicates an improvement (less time to read the passage).

  Baseline, Month 6

• Change From Baseline in Reading Rate

  Reading speed was assessed as the number of words read correctly calculated as words/minute. A positive change from Baseline indicates an improvement (more words read correctly/minute) and a negative change from Baseline indicates a worsening (less words read correctly/minute).

  Baseline, Month 6

Secondary Outcomes (11)

• Change From Baseline in Tear Film Break Up Time (TFBUT) in the Worse Eye

  Baseline, Month 6

• Change From Baseline in Ocular Protection Index (OPI) 2.0 in the Worse Eye

  Baseline, Month 6

• Change From Baseline in Interblink Interval (IBI) in the Worst Eye

  Baseline, Month 6

• Change From Baseline in OSDI© Total Score

  Baseline, Month 6

• Change From Baseline in Driving at Night on the OSDI©

  Baseline, Month 6

Study Arms (1)

RESTASIS®

EXPERIMENTAL

1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.

Drug: Cyclosporine 0.05% Ophthalmic Emulsion

Interventions

Cyclosporine 0.05% Ophthalmic Emulsion DRUG

Cyclosporine 0.05% Ophthalmic Emulsion (RESTASIS®) 1 drop instilled in each eye twice a day.

Also known as: RESTASIS®

RESTASIS®

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Has Eye Symptoms when using video display terminals
• Has a reported history of dry eye in both eyes.

You may not qualify if:

• Diagnosed with eye infection or active inflammation.
• Has worn contact lenses within the past 7 days or anticipated use during the study.
• Has used any eye drops within 2 hours.
• Has had laser-assisted in situ keratomileusis (LASIK) within 12 months.
• Has used Restasis® within 90 days.
• Has had any eye and or/lid surgeries within 6 months.
• Has had cataract surgery in either eye.
• Has current punctal occlusion or anticipate a change in punctal occlusion status at any point during the study.
• Is currently taking any topical ophthalmic prescriptions or over-the-counter solutions, artificial tears, gels or lid scrubs that cannot be discontinued for the trial duration.
• Use of medication known to cause ocular drying that is not on a stable dose for at least 30 days.

Sponsors & Collaborators

• Allergan: lead

Study Sites (2)

Andover Eye Associates, Inc

Andover, Massachusetts, 01810, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

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

• Jai Parekh

  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: September 17, 2015
• First Posted: September 21, 2015
• Study Start: July 21, 2015
• Primary Completion: March 24, 2016
• Study Completion: March 24, 2016
• Last Updated: June 1, 2017
• Results First Posted: June 1, 2017

Record last verified: 2017-05

Locations

US (2)