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NCT01294956 Clinical Trial

A Clinical Evaluation of an Investigational Lubricant Eye Gel (FID 115958D)

Dry Eye Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01294956
Other study ID # C-10-043
Secondary ID
Status Completed
Phase N/A
First received February 10, 2011
Last updated November 17, 2016
Start date January 2011
Est. completion date April 2011

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

Clinical Trial Summary

The purpose of this study is to estimate the change in sodium fluorescein staining, as a sign of dry eye, during six weeks of treatment with FID 115958D or Refresh Liquigel.

Recruitment information / eligibility
Status Completed
Enrollment 147
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Documented diagnosis of dry eye

- NaFl Corneal staining sum score = 3 in either eye

- Current use of a lubricant eye gel or ointment at least once per week (over the previous month)

Exclusion Criteria:

- No contact lenses wear throughout the study period

- Must not have had punctal plugs inserted within 30 days preceding enrollment

Study Design

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

Related Conditions & MeSH terms

Intervention

Other:
• Lubricant Eye Drop
1 drop in each eye, four times a day for 42 days
• Refresh Liquigel
1 drop in each eye, four times a day for 42 days

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

References & Publications (1)

Cohen S, Martin A, Sall K. Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose. Clin Ophthalmol. 2014;8:157-64. doi: 10.2147/OPTH.S53822. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Corneal Staining Day 42 No
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