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CompletedNCT00469157Updated Apr 17, 2008

Refractive Surgery and Optive Compatibility Study

A Phase 4 interventional study of Optive in Dry Eye Syndromes, sponsored by Innovative Medical. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-04-17.

Sponsored by Innovative Medical · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
92
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Dry Eye Syndromes

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Keywords

  • compatibility of Optive after PRK or LASIK
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 192 are open to participants now.

This study's enrollment of 92 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Innovative Medical is the lead sponsor of 50 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
92 participants (actual)

Study arms

  • Other
    1.

    Drug: Optive

Interventions

  • DrugOptive

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

06

What researchers measure

Primary outcomes

  1. Assess compatibility

    Time frame: 8 months

Secondary outcomes

  1. comfort

    Time frame: 8 months

07

Study locations

1 site
  • TLC
    Fullerton, California 92831, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00469157
Lead sponsor
Innovative Medical
First posted
May 4, 2007
Start date
May 2007
Primary completion
Apr 2008
Completion
Apr 2008
Last update
Apr 17, 2008

Study contacts

Loren Rude, OD
principal investigator · TLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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