Evaluation of Extended Tear Film Break Up Time (TFBUT) With an Ocular Emulsion

Dry Eye Clinical Trial

Official title:

The Evaluation of Extended Tear Film Break Up Time (TFBUT) With an Ocular Emulsion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368198
• Other study ID #: ID11-10
• Status: Completed
• Phase: N/A
• First received: May 6, 2011
• Last updated: January 31, 2012
• Start date: March 2011
• Est. completion date: June 2011

Study information

• Verified date: January 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

The secondary objective of this investigation will be to compare the tear film break up time measured with two different techniques.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The subject must be 18 years of age or older;

2. The subject must have a best corrected visual acuity of 0.6 LogMAR (~6/24) or better in each eye

3. The subject must not have used any topical ocular drops for approximately 24 hours prior to the enrolment/screening visit

4. 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.

Exclusion Criteria:

1. History or evidence of ocular or intraocular surgery in either eye within the past six months.

2. History or evidence of serious ocular trauma in either eye within the past six months.

3. Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).

4. 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.

5. Use of any concomitant topical ocular medications during the study period.

6. Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation.

7. Participation in an investigational drug or device study within 30 days of entering this study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dry Eye

Intervention

Other:
• Systane Balance Lubricating Eye Drops
One instillation of the eye drop in each eye
• OPTIVE™
One instillation of the eye drop in each eye

Locations

Country	Name	City	State
United Kingdom	OTG Research & Consultancy	London	England
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Alcon Research	Optometric Technology Group Ltd

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of the tear film break-up time using DET sodium fluorescein strips.		Enrollment Test visit 1	No
Secondary	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	No