NCT02280473

Brief Summary

This study will evaluate the safety and efficacy o fRefresh Optive® Gel Drops in patients with dry eye disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
13 days until next milestone

Study Start

First participant enrolled

November 13, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2015

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

June 7, 2017

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

4 months

First QC Date

October 29, 2014

Results QC Date

May 12, 2017

Last Update Submit

April 9, 2019

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score

    The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.

    Baseline, Day 30

Secondary Outcomes (4)

  • Change From Baseline in the OSDI© Score

    Baseline, Day 7

  • Change From Baseline in Tear Break-up Time (TBUT)

    Baseline, Day 30

  • Change From Baseline in the Combined Corneal and Conjunctival Staining Scores

    Baseline, Day 30

  • Change From Baseline in the Schirmer Test

    Baseline, Day 30

Study Arms (2)

Refresh Optive® Gel Drops

EXPERIMENTAL

Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Drug: Refresh Optive® Gel Drops

REFRESH LIQUIGEL®

ACTIVE COMPARATOR

REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Drug: REFRESH LIQUIGEL®

Interventions

Refresh Optive® Gel DropsDRUG

Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Refresh Optive® Gel Drops
REFRESH LIQUIGEL®DRUG

REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.

REFRESH LIQUIGEL®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current use of an artificial tear product
  • Visual acuity of at least 20/32 (while wearing glasses, if necessary).

You may not qualify if:

  • Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
  • Cataract surgery, laser-assisted in situ keratomileusis \[LASIK\], or photorefractive keratectomy, within the last 6 months
  • Current eye infection or inflammation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

North Bay Eye Associates

Petaluma, California, 94954, United States

Location

Eric M. White, OD, Inc.

San Diego, California, 92123, United States

Location

Eye Center Northeast

Bangor, Maine, 04401, United States

Location

Moyes Eye Center, PC

Kansas City, Missouri, 64154, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Comprehensive Eye Care, Ltd.

Washington, Missouri, 63090, United States

Location

Rochester Ophthalmological Group, PC

Rochester, New York, 14618, United States

Location

David W. Ferris & Associates, Inc.

Warwick, Rhode Island, 02888, United States

Location

Primary Eyecare Group, PC

Brentwood, Tennessee, 37027, United States

Location

The Eye Center at Southern College of Optometry

Memphis, Tennessee, 38104, United States

Location

Related Publications (1)

  • Lievens C, Berdy G, Douglass D, Montaquila S, Lin H, Simmons P, Carlisle-Wilcox C, Vehige J, Haque S. Evaluation of an enhanced viscosity artificial tear for moderate to severe dry eye disease: A multicenter, double-masked, randomized 30-day study. Cont Lens Anterior Eye. 2019 Aug;42(4):443-449. doi: 10.1016/j.clae.2018.12.003. Epub 2018 Dec 17.

    PMID: 30573298BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Carboxymethylcellulose Sodium

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

MethylcelluloseCelluloseGlucansPolysaccharidesCarbohydrates

Results Point of Contact

Title
Michael Robinson
Organization
Allergan plc
Robinson_Michael@Allergan.com
1-714-246-6415

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 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2014

First Posted

October 31, 2014

Study Start

November 13, 2014

Primary Completion

March 16, 2015

Study Completion

March 16, 2015

Last Updated

April 16, 2019

Results First Posted

June 7, 2017

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(10)