NCT00469157

Brief Summary

To assess the compatibility of Optive with refractive surgery (PRK and LASIK) post-operatively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 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
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

April 17, 2008

Status Verified

April 1, 2008

Enrollment Period

11 months

First QC Date

May 2, 2007

Last Update Submit

April 16, 2008

Conditions

Dry Eye Syndromes

Keywords

compatibility of Optive after PRK or LASIK

Outcome Measures

Primary Outcomes (1)

  • Assess compatibility

    8 months

Secondary Outcomes (1)

  • comfort

    8 months

Study Arms (1)

1.

OTHER
Drug: Optive

Interventions

OptiveDRUG

Optive 30ml- (in the eye) Instill one in each eye twice daily starting one week after surgery

1.

Eligibility Criteria

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

You may qualify if:

  • Men and women 18 and over
  • Patients undergoing refractive surgery

You may not qualify if:

  • Concurrent ocular conditions or pathology that could affect 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TLC

Fullerton, California, 92831, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Loren Rude, OD

    TLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
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

April 1, 2008

Study Completion

April 1, 2008

Last Updated

April 17, 2008

Record last verified: 2008-04

Locations

US(1)