NCT01051804

Brief Summary

Comparison of two contact lens solutions.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

8 months

First QC Date

January 18, 2010

Last Update Submit

January 31, 2012

Conditions

Dry Eye

Keywords

Dry eyeVisual Performance

Outcome Measures

Primary Outcomes (1)

  • Improvement in objective vision

    4 weeks

Secondary Outcomes (1)

  • Measurement of tear film evaporation

    4 weeks

Study Arms (2)

Systane Ultra

EXPERIMENTAL

Systane Ultra Lubricant Eye Drops

Other: Systane Ultra

Optive

ACTIVE COMPARATOR

Optive Lubricant Eye Drops

Other: Optive lubricant Eye Drops

Interventions

Systane UltraOTHER

Systane Ultra 1 to 2 drops per eye at least 4 times daily for 4 weeks

Systane Ultra
Optive lubricant Eye DropsOTHER

Optive Lubricant Eye Drops 1 to 2 drops per eye at least 4 times daily for 4 weeks

Optive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2010

First Posted

January 20, 2010

Study Start

November 1, 2009

Primary Completion

July 1, 2010

Last Updated

February 2, 2012

Record last verified: 2012-01