NCT00469573

Brief Summary

The purpose of this study is to determine if Optive®eye drops are safe for people who wear contact lenses and have dry eyes. The second goal of the study is to determine if using Optive®eye drops can improve my dry eye scores on a standard dry eye test (called the OSDI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

April 1, 2008

Status Verified

March 1, 2008

Enrollment Period

10 months

First QC Date

May 2, 2007

Last Update Submit

March 31, 2008

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Safety

    8 months

Secondary Outcomes (1)

  • Efficacy

    8 months

Study Arms (1)

1.

OTHER
Drug: 1. Optive

Interventions

1. OptiveDRUG

Optive 15ml- (in the eye) Instill one drop twice daily in each eye

1.

Eligibility Criteria

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

You may qualify if:

  • Men and women 18 and over
  • Self-reported use of daily-wear soft contact lenses that have been a proper fit for at least one month prior to the screening visit.
  • Complaint of dry eyes
  • OSDI score \> 23

You may not qualify if:

  • Use of RGP or PMMA contact lenses
  • Poorly fitting contact lenses
  • Concurrent ocular conditions or pathology that could affect contact lens fit or patient's ability to complete study
  • Concurrent use of topical medications other than study medications
  • Use of systemic medications with ocular drying sequelae:
  • Antihistamines
  • Decongestants
  • Antispasmotics Antidepressants Change in contact lens care solutions within the prior 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Shore Eye Care

Wantagh, New York, 11793, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Jodi Luchs, MD

    South Shore Eye Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 2, 2007

First Posted

May 4, 2007

Study Start

May 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

April 1, 2008

Record last verified: 2008-03

Locations

US(1)