Corneal StainingPhase 4NCT00518700
Comfort Evaluation of a New MPS vs. Replenish in Contact Lens Patients
A Phase 4 study testing new MPS and RepleniSH in people with Corneal Staining, run by Innovative Medical at 1 site in United States.
Trial summary
To compare corneal staining after contact lens instillation with a new MPS vs. RepleniSH Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Staining
- What is being tested?
- new MPS and RepleniSH
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento 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
- Adult, Older adult
Who may be able to join
- Patients 18 yrs or older
- Males or females
- Any race or ethnic background
- CL patients using MPS products currently
- Patients using Contact Lenses habitually (at least 1 month)
Who cannot join
- Corneal refractive surgery within 6 months of this study.
- Contact lens use on day of examination.
- Corneal ectasia.
- Current use of Restasis
Trial locations and contacts
1 site in 1 country.
About this study
To compare corneal staining after contact lens instillation with a new MPS vs. RepleniSH
- Conditions
- Corneal Staining
- Being tested
- new MPS, RepleniSH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new MPSOther
RepleniSHOther
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2007 (estimated)
- 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 Corneal StainingStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Milton Hom, OD, FAAO, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518700
- Sponsor's protocol ID
- 5321
- Status last verified
- Apr 2008
- First submitted
- 17 Aug 2007
- Last updated
- 24 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comfort Evaluation of a New MPS vs. Replenish in Contact Lens Patients
- ClinicalTrials.gov ID
- NCT00518700
- Acronym / sponsor ID
- 5321
- Conditions
- Corneal Staining
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 21 Aug 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 corneal staining after contact lens instillation with a new MPS vs. RepleniSH
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients 18 yrs or older
- Males or females
- Any race or ethnic background
- CL patients using MPS products currently
- Patients using Contact Lenses habitually (at least 1 month)
Key exclusion criteria (4 listed)
- Corneal refractive surgery within 6 months of this study.
- Contact lens use on day of examination.
- Corneal ectasia.
- Current use of Restasis
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 |
|---|---|---|
| new MPS | Other | – |
| RepleniSH | Other | – |
Primary outcome
Not reported in the source record.
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 24 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.
Milton Hom, OD, FAAO principal investigator
Private Practice
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 new MPS and RepleniSH in people with Corneal Staining, 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 5 inclusion and 4 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 24 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.
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 24 Apr 2008.