Evaluation of the Repeated Usage of Systane Ultra Eyedrop

Dry Eye Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01051804
• Other study ID #: SMA-09-33
• Status: Completed
• Phase: Phase 4
• First received: January 18, 2010
• Last updated: January 31, 2012
• Start date: November 2009

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

Comparison of two contact lens solutions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or more.

• Non contact lens wearer.

• Symptomatology as defined below for the Ocular Surface Disease Index (OSDI) questionnaire:

• Score =13 for OSDI Questionnaire total score; AND

• Scores of at least 2 for 2 out of the 6 vision related questions of the OSDI questionnaire

• Best visual acuity of 6/9 or better in each eye.

• Willingness to adhere to the instructions set in the clinical protocol.

• Signature of the subject informed consent form.

Exclusion Criteria:

• Use of systemic medication which might produce dry eye side effects.

• Systemic disease which might produce dry eye side effects.

• Active ocular infection.

• Use of ocular medication.

• Significant ocular anomaly.

• Previous ocular surgery

• Previous use of Restasis

• Any medical condition that might be prejudicial to the study.

• The subject, based on their knowledge, must NOT be pregnant or lactating at the time of enrolment.

• The subject, based on his/her knowledge, must NOT have an infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. Human Immunodeficiency Virus).

• The subject, based on their knowledge, must NOT have diabetes.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye

Intervention

Other:
• Systane Ultra
Systane Ultra 1 to 2 drops per eye at least 4 times daily for 4 weeks
• Optive lubricant Eye Drops
Optive Lubricant Eye Drops 1 to 2 drops per eye at least 4 times daily for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in objective vision		4 weeks	No
Secondary	Measurement of tear film evaporation		4 weeks	No