Dry Eye SyndromesPhase 4NCT00469157
Refractive Surgery and Optive Compatibility Study
A Phase 4 study testing Optive in people with Dry Eye Syndromes, run by Innovative Medical at 1 site in United States.
Trial summary
To assess the compatibility of Optive with refractive surgery (PRK and LASIK) post-operatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Optive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Apr 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 18 and over
- Patients undergoing refractive surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
To assess the compatibility of Optive with refractive surgery (PRK and LASIK) post-operatively.
- Conditions
- Dry Eye Syndromes
- Being tested
- Optive
- Keywords
- compatibility of Optive after PRK or LASIK
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptiveDrug
Optive 30ml- (in the eye) Instill one in each eye twice daily starting one week after surgery
| Study group | Role | What they receive |
|---|---|---|
| 1. | Other | Not described Receives: Drug: Optive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess compatibility
Measured: 8 months
Secondary outcomes (1)
comfort
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startMay 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Loren Rude, OD, Principal investigator, TLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469157
- Sponsor's protocol ID
- 5303
- Status last verified
- Apr 2008
- First submitted
- 2 May 2007
- Last updated
- 17 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractive Surgery and Optive Compatibility Study
- ClinicalTrials.gov ID
- NCT00469157
- Acronym / sponsor ID
- 5303
- Conditions
- Dry Eye Syndromes
- Keywords
- compatibility of Optive after PRK or LASIK
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 4 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the compatibility of Optive with refractive surgery (PRK and LASIK) post-operatively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1. | Other | Drug: Optive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women 18 and over
- Patients undergoing refractive surgery
Key exclusion criteria (7 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OptiveOptive 30ml- (in the eye) Instill one in each eye twice daily starting one week after surgery | Drug | 1. |
Primary outcome
Assess compatibility
Time frame: 8 months
1 secondary outcome
comfort
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loren Rude, OD principal investigator
TLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Optive in people with Dry Eye Syndromes, run by Innovative Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess compatibility (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2008.