NCT01368198

Brief Summary

The primary objective of this investigation will be to quantify the increase in tear film break-up time (TFBUT) associated with the instillation of a single eyedrop of an Ocular Emulsion in dry eye sufferers.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2011

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

3 months

First QC Date

May 6, 2011

Last Update Submit

January 31, 2012

Conditions

Dry Eye

Keywords

Ocular EmulsionOPTIVE™ LubricantTear Film Break Up Time

Outcome Measures

Primary Outcomes (1)

  • Measurement of the tear film break-up time using DET sodium fluorescein strips.

    Enrollment Test visit 1

Secondary Outcomes (1)

  • Measurement of the tear film break-up time in a non invasive manner using the Tearscope®. Measurement of the tear film break-up time in a non invasive manner using the Tearscope®.

    Enrollment Test visit 2

Study Arms (2)

Ocular Emulsion

ACTIVE COMPARATOR

An Ocular Emulsion

Other: Systane Balance Lubricating Eye Drops

OPTIVE™

ACTIVE COMPARATOR

An OPTIVE™

Other: OPTIVE™

Interventions

Systane Balance Lubricating Eye DropsOTHER

One instillation of the eye drop in each eye

Also known as: Ocular Emulsion
Ocular Emulsion
OPTIVE™OTHER

One instillation of the eye drop in each eye

Also known as: Optive
OPTIVE™

Eligibility Criteria

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

You may qualify if:

  • The subject must be 18 years of age or older;
  • The subject must have a best corrected visual acuity of 0.6 LogMAR (\~6/24) or better in each eye
  • The subject must not have used any topical ocular drops for approximately 24 hours prior to the enrolment/screening visit
  • The subject must be classified as dry eye at enrolment/screening visit according to the following criteria:
  • Subjects' self-assessment of dry eye status (answer of at least "some of the time" to the question, "How often have your eyes felt dry enough to want to use eye drops?");
  • TFBUT measured with DET ≤ 5 seconds in at least one eye;
  • Grade 1 for meibomian gland expression in both eyes;
  • Evidence of missing meibomian glands in both eyes.

You may not qualify if:

  • History or evidence of ocular or intraocular surgery in either eye within the past six months.
  • History or evidence of serious ocular trauma in either eye within the past six months.
  • Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).
  • History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
  • Use of any concomitant topical ocular medications during the study period.
  • Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation.
  • Participation in an investigational drug or device study within 30 days of entering this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

OTG Research & Consultancy

London, England, SW1E 6AU, United Kingdom

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2011

First Posted

June 7, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

February 2, 2012

Record last verified: 2012-01

Locations

US(1)GB(1)