Evaluation of the Repeated Usage of Systane Ultra Eyedrop
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01051804
First received: January 18, 2010
Last updated: January 31, 2012
Last verified: January 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Comparison of two contact lens solutions.
| Condition | Intervention | Phase |
|---|---|---|
|
Dry Eye |
Other: Systane Ultra Other: Optive lubricant Eye Drops |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Improvement in objective vision [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Measurement of tear film evaporation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 57 |
| Study Start Date: | November 2009 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT01051804 History of Changes |
| Other Study ID Numbers: | SMA-09-33 |
| Study First Received: | January 18, 2010 |
| Last Updated: | January 31, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Alcon Research:
|
Dry eye Visual Performance |
Additional relevant MeSH terms:
|
Keratoconjunctivitis Sicca Dry Eye Syndromes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases Tetrahydrozoline |
Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013