NCT01664949

Brief Summary

This study will evaluate the safety and efficacy of a carboxymethylcellulose based eye drop formulation compared with carboxymethylcellulose based preservative-free lubricant eye drops (OPTIVE™) in subjects with dry eye disease.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
460

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_3

Geographic Reach
8 countries

12 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

August 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 8, 2015

Completed
Last Updated

September 21, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

August 10, 2012

Results QC Date

May 22, 2015

Last Update Submit

September 8, 2015

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90

    The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst). A negative number 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

    Baseline, Day 90

  • Change From Baseline in Conjunctival Staining

    Baseline, Day 90

  • Change From Baseline in the Schirmer Test

    Baseline, Day 90

Study Arms (2)

Carboxymethylcellulose Based Eye Drop Formulation A

EXPERIMENTAL

Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.

Drug: Carboxymethylcellulose Based Eye Drop Formulation A

OPTIVE™

ACTIVE COMPARATOR

Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.

Drug: Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops

Interventions

Carboxymethylcellulose Based Eye Drop Formulation ADRUG

Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.

Carboxymethylcellulose Based Eye Drop Formulation A
Carboxymethylcellulose Based Preservative-Free Lubricant Eye DropsDRUG

Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.

Also known as: REFRESH OPTIVE™, OPTAVA™
OPTIVE™

Eligibility Criteria

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

You may qualify if:

  • Have used artificial tears for dry eye

You may not qualify if:

  • Start date of over the counter, herbal, prescription or nutritional supplements that may affect dry eye or vision within 3 months prior to study start or an anticipated change in dosage during the study
  • History of eye surgery or trauma in the 6 months prior to study start
  • Current use or use within 2 weeks of study start, of topical eye medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Randwick, New South Wales, Australia

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Marseille, France

Location

Unknown Facility

Tours, France

Location

Unknown Facility

Freiburg im Breisgau, Germany

Location

Unknown Facility

Padua, Italy

Location

Unknown Facility

Parma, Italy

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Huelva, Spain

Location

Unknown Facility

Valencia, Spain

Location

Unknown Facility

Southampton, Hampshire, United Kingdom

Location

Unknown Facility

Great Yarmouth, Norfolk, United Kingdom

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
Therapeutic Area Head,
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 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

August 10, 2012

First Posted

August 14, 2012

Study Start

January 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

September 21, 2015

Results First Posted

June 8, 2015

Record last verified: 2015-09

Locations

DE(1)BE(1)ES(2)AU(1)IT(2)GB(2)FR(2)RU(1)