Evaluation of the Repeated Usage of Systane Ultra Eyedrop

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01051804
• Collaborator: (none)
• Enrollment: 57
• Arms: 2

Study Details

Study Description

Brief Summary

Comparison of two contact lens solutions.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Other: Systane Ultra; Other: Optive lubricant Eye Drops	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Systane Ultra Systane Ultra Lubricant Eye Drops	Other: Systane Ultra; Systane Ultra 1 to 2 drops per eye at least 4 times daily for 4 weeks
Active Comparator: Optive Optive Lubricant Eye Drops	Other: Optive lubricant Eye Drops; Optive Lubricant Eye Drops 1 to 2 drops per eye at least 4 times daily for 4 weeks

Outcome Measures

Primary Outcome Measures

1. Improvement in objective vision [4 weeks]

Secondary Outcome Measures

1. Measurement of tear film evaporation [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01051804
• Other Study ID Numbers: SMA-09-33
• First Posted: Jan 20, 2010
• Last Update Posted: Feb 2, 2012
• Last Verified: Jan 1, 2012

• Keywords provided by Alcon Research: Dry eye; Visual Performance
• Additional relevant MeSH terms: Dry Eye Syndromes; Ophthalmic Solutions; Lubricant Eye Drops

Study Results

No Results Posted as of Feb 2, 2012