Dry EyePhase 4NCT00477763
Oasys vs. Extreme H20 Xtra 59
A Phase 4 study testing Restasis, Refresh Endura in people with Dry Eye, run by Innovative Medical at 1 site in United States.
Trial summary
To compare the performance of Oasys to Extreme H20 xtra 59 in dry eye contact lens pts who receive Restasis in 1 eye and vehicle (Endura) in the other eye. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Restasis, Refresh Endura
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Feb 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female at least 19 years of age
- Contact Lens Wearers
- Patients with mild to moderate symptoms of dry eye
Who cannot join
- male or female younger than 19 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Hazleton Eye Specialists
Hazleton, Pennsylvania, 18202
About this study
To compare the performance of Oasys to Extreme H20 xtra 59 in dry eye contact lens pts who receive Restasis in 1 eye and vehicle (Endura) in the other eye.
- Conditions
- Dry Eye
- Being tested
- Restasis, Refresh Endura
- 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.
Restasis, Refresh EnduraDrug
- Restasis 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening
- Refresh Endura 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Restasis, Refresh Endura |
| 2 | Placebo comparator | Not described Receives: Drug: Restasis, Refresh Endura |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing performance of contact lens
Measured: 10 months
Secondary outcomes (1)
Dry eye
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startMay 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Kislan, OD, Principal investigator, Hazleton Eye Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477763
- Sponsor's protocol ID
- 5300
- Status last verified
- Feb 2008
- First submitted
- 21 May 2007
- Last updated
- 18 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oasys vs. Extreme H20 Xtra 59
- ClinicalTrials.gov ID
- NCT00477763
- Acronym / sponsor ID
- 5300
- Conditions
- Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 24 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 compare the performance of Oasys to Extreme H20 xtra 59 in dry eye contact lens pts who receive Restasis in 1 eye and vehicle (Endura) in the other eye.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Restasis, Refresh Endura |
| 2 | Placebo comparator | Drug: Restasis, Refresh Endura |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female at least 19 years of age
- Contact Lens Wearers
- Patients with mild to moderate symptoms of dry eye
Key exclusion criteria (1 listed)
- male or female younger than 19 years of age
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 |
|---|---|---|
| Restasis, Refresh Endura1. Restasis 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening 2. Refresh Endura 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening | Drug | 1, 2 |
Primary outcome
comparing performance of contact lens
Time frame: 10 months
1 secondary outcome
Dry eye
Time frame: 10 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 18 Feb 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.
Thomas Kislan, OD principal investigator
Hazleton Eye Specialists
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 Restasis, Refresh Endura in people with Dry Eye, 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 3 inclusion and 1 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 18 Feb 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. Some participants in this study may receive a placebo. 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?
comparing performance of contact lens (time frame: 10 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 18 Feb 2008.