Tear Film Break-Up Time Evaluation of FID 114657

Dry Eye Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023464
• Other study ID #: C-09-030
• Status: Completed
• Phase: N/A
• First received: November 25, 2009
• Last updated: November 17, 2016
• Start date: October 2009

Study information

• Verified date: February 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To evaluate the effects of FID 114657 on tear film break-up time in dry eye patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The informed consent document and HIPAA privacy document must be read, signed and dated by the patient or legally authorized representative before conducting any procedures.

2. Patients (minimum age 18) with dry eye. Criteria for the diagnosis must include the following characteristics at Visit 1 (Screening): Patients' 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 <5 seconds in at least one eye; > Grade 1 for Meibomian Gland Expression in both eyes; Evidence of missing meibomian glands in both eyes.

3. Able and willing to follow study instructions.

4. Patients must have best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart at Visit 1.

5. Patients must not have used any topical ocular drops for approximately 24 hours prior to Visit 1.

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 of intolerance or hypersensitivity to any component of the study medications.

5. 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.

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

7. Patients using systemic medications that may contribute to dry eye (e.g. cold and allergy medications, tricyclic antidepressants, hormone replacement therapies) may not be enrolled in the study unless they have been on a stable dosing regimen for a minimum of 30 days prior to Visit 1. In addition, the dosing regimen must remain stable throughout the study.

8. Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude safe administration of the test article.

9. Individuals unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued at least one week prior to Visit 1.

10. Enrollment of investigator's office staff, relatives, or members of their respective households; or enrollment of more than one member of the same household.

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye

Intervention

Other:
• FID114657
artificial tears
• SootheXP Emollient (Lubricant) Eye Drops
artificial tears

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

References & Publications (1)

Benelli U. Systane lubricant eye drops in the management of ocular dryness. Clin Ophthalmol. 2011;5:783-90. doi: 10.2147/OPTH.S13773. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tear film break-up time (TFBUT)		Instill assigned test article to both eyes and begin timing the evaluation process. Measure TFBUT at 15, 30, 60 and 120 minutes post instillation.	No
Secondary	Acute comfort		Immediately post instillation of test article	No