NCT02553772

Brief Summary

This study will evaluate the safety and efficacy of a new eye drop formulation in patients with dry eye disease.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
242

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_3

Geographic Reach
2 countries

13 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

September 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

January 6, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2016

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 17, 2017

Completed
Last Updated

November 17, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

September 16, 2015

Results QC Date

August 16, 2017

Last Update Submit

October 18, 2017

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

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

    The OSDI© consists of 12 questions the patient is asked measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale where 0=none of the time and 4=all of the time. The score is converted to a 0 to 100-point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement.

    Baseline, Day 90

Secondary Outcomes (4)

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

    Baseline, Day 90

  • Change From Baseline in Corneal Staining Score

    Baseline, Day 90

  • Change From Baseline in Conjunctival Staining Score

    Baseline, Day 90

  • Change From Baseline in the Schirmer Test

    Baseline, Day 90

Study Arms (2)

OM3 Tear

EXPERIMENTAL

Carboxymethylcellulose based eye drop \[Omega-3 (OM3) Tear\] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.

Drug: Carboxymethylcellulose Based Eye Drop

REFRESH OPTIVE® ADVANCED

ACTIVE COMPARATOR

Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.

Drug: Carboxymethylcellulose Sodium 0.5%

Interventions

Carboxymethylcellulose Based Eye DropDRUG

Carboxymethylcellulose based eye drop (OM3 Tear) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.

OM3 Tear
Carboxymethylcellulose Sodium 0.5%DRUG

Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.

Also known as: REFRESH OPTIVE® ADVANCED
REFRESH OPTIVE® ADVANCED

Eligibility Criteria

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

You may qualify if:

  • Used artificial tears for dry eye
  • 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
  • Herpes keratitis in the last 6 months
  • Cataract surgery, laser-assisted in situ keratomileusis \[LASIK\], or photorefractive keratectomy, within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

The Private Practice of Milton Hom, OD

Azusa, California, 91702, United States

Location

Havana Research Institute LLC

Burbank, California, 91506, United States

Location

Lugene Eye Institute

Glendale, California, 91204, United States

Location

Eric M. White, OD, INC

San Diego, California, 92123, United States

Location

Moyes Eye Center, PC

Kansas City, Missouri, 64154, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Rochester Ophthalmological Group, PC

Rochester, New York, 14618, United States

Location

Charlotte Eye Ear Nose

Charlotte, North Carolina, 28210, United States

Location

Scott and Christie and Associate

Cranberry Township, Pennsylvania, 16066, United States

Location

Texan Eye

Austin, Texas, 78731, United States

Location

Department of Optometry & Vision Sciences, The University of Melbourne

Parkville, VIC 3010, Australia

Location

Prof. M.T. Coroneo Pty. Ltd.

Randwick, NSW 2031, Australia

Location

The University of New South Wales School of Optometry and Vision Science

Sydney, NSW 2052, Australia

Location

Related Links

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
Therapeutic Area Head,
Organization
Allergan, Inc
IR-CTRegistration@allergan.com
1-877-277-8566

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

September 16, 2015

First Posted

September 18, 2015

Study Start

January 6, 2016

Primary Completion

September 9, 2016

Study Completion

September 9, 2016

Last Updated

November 17, 2017

Results First Posted

November 17, 2017

Record last verified: 2017-10

Locations

US(10)AU(3)