NCT02117687

Brief Summary

This study will evaluate the safety and efficacy of OPTIVE FUSION™ compared to VISMED® Multi for the management of dry eye.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2014

Shorter than P25 for phase_4

Geographic Reach
2 countries

2 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

April 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
23 days until next milestone

Study Start

First participant enrolled

May 14, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2015

Completed
11 months until next milestone

Results Posted

Study results publicly available

February 19, 2016

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

9 months

First QC Date

April 16, 2014

Results QC Date

January 22, 2016

Last Update Submit

April 9, 2019

Conditions

Dry Eye SyndromesKeratoconjunctivitis Sicca

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Global Ocular Staining Score in the Study Eye

    Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.

    Baseline, Day 35

Secondary Outcomes (13)

  • Change From Baseline in Global Ocular Staining Score in the Study Eye

    Baseline, Month 3

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

    Baseline, Day 35

  • Change From Baseline in the Schirmer Test in the Study Eye

    Baseline, Day 35

  • Subject Assessment of Dry Eye Symptoms on a 5-Point Scale

    Baseline, Day 35, Month 3

  • Subject Global Assessment of Treatment Efficacy on a 5-Point Scale

    Baseline, Day 35, Month 3

  • +8 more secondary outcomes

Study Arms (2)

OPTIVE FUSION™

ACTIVE COMPARATOR

1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.

Drug: carboxymethylcellulose 0.5%/glycerin 0.9%

VISMED® Multi

ACTIVE COMPARATOR

1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.

Drug: sodium hyaluronate 0.18%

Interventions

carboxymethylcellulose 0.5%/glycerin 0.9%DRUG

1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.

Also known as: OPTIVE FUSION™
OPTIVE FUSION™
sodium hyaluronate 0.18%DRUG

1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.

Also known as: VISMED® Multi
VISMED® Multi

Eligibility Criteria

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

You may qualify if:

  • Use of artificial tears for dry eye in both eyes for at least 3 months
  • Use of preservative-free artificial tears at least twice daily for 2 weeks;

You may not qualify if:

  • Cataract, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK) surgery in the last 12 months
  • Use of punctal plugs or contact lenses in the last month
  • Active ocular allergy within last 2 years
  • Best corrected visual acuity (BCVA) less than 20/200 in either eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Paris, France

Location

Unknown Facility

London, United Kingdom

Location

Related Publications (1)

  • Labetoulle M, Chiambaretta F, Shirlaw A, Leaback R, Baudouin C. Osmoprotectants, carboxymethylcellulose and hyaluronic acid multi-ingredient eye drop: a randomised controlled trial in moderate to severe dry eye. Eye (Lond). 2017 Oct;31(10):1409-1416. doi: 10.1038/eye.2017.73. Epub 2017 Apr 28.

    PMID: 28452989BACKGROUND

MeSH Terms

Conditions

Dry Eye SyndromesKeratoconjunctivitis Sicca

Interventions

Carboxymethylcellulose Sodium

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesKeratoconjunctivitisConjunctivitisConjunctival DiseasesKeratitisCorneal Diseases

Intervention Hierarchy (Ancestors)

MethylcelluloseCelluloseGlucansPolysaccharidesCarbohydrates

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
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2014

First Posted

April 21, 2014

Study Start

May 14, 2014

Primary Completion

January 27, 2015

Study Completion

March 17, 2015

Last Updated

April 18, 2019

Results First Posted

February 19, 2016

Record last verified: 2019-04

Locations

GB(1)FR(1)