Comfort, Vision and Wear TimePhase 4NCT00570843
Masked Comparison of a New PEG Based Artificial Tear and Optive for Comfort, Vision & Wear Time in Patients Wearing Contact Lenses
A Phase 4 study testing New PEG based artificial tear and Optive in people with Comfort, Vision and Wear Time, run by Bp Consulting, Inc at 1 site in United States.
Trial summary
The objective of this study is to evaluate the effect of a new PEG based artificial tear as compared to Optive on comfort, wear time, and vision in patients wearing contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Comfort, Vision and Wear Time
- What is being tested?
- New PEG based artificial tear and Optive
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Feb 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Use of soft contact lenses (e.g. silicone hydrogel lenses, daily disposables etc.) and multipurpose solution for cleaning, including enzyme-based cleaners (ClearCare etc.)
- Able to wear contact lenses for approximately 10-12 hours/day
- Willingness to complete entire length of trial and comply with subjective questionnaire.
Who cannot join
- Patients taking topical cyclosporine (Restasis)
- Patients currently using Optive for dryness relief.
- Patients wearing hard or rigid gas permeable lenses
- Patients with uncontrolled systemic disease which may confound the results of the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
The New York Presbyterian Hospital-Weill Cornell Medical College
New York, New York, 10021
About this study
Official title: Phase 4 Masked Comparison of a New PEG Based Artificial Tear and Optive for Comfort, Vision & Wear Time in Patients Wearing Contact Lenses
The objective of this study is to evaluate the effect of a new PEG based artificial tear as compared to Optive on comfort, wear time, and vision in patients wearing contact lenses.
- Conditions
- Comfort, Vision and Wear Time
- Being tested
- New PEG based artificial tear, Optive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New PEG based artificial tearDrug
1, 2, (in the eye) Instill one drop in the left eye or right eye four times daily (can be used more frequently if needed)
OptiveDrug
1, 2, (in the eye) Instill one drop in the left eye or right eye four times daily (can be used more frequently if needed)
| Study group | Role | What they receive |
|---|---|---|
| 1. | Active comparator | Not described Receives: Drug: New PEG based artificial tear |
| 2. | Placebo comparator | Not described Receives: Drug: Optive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
Measured: 1 month
Secondary outcomes (1)
vision and wear time
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startMar 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comfort, Vision and Wear TimeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bp Consulting, Inc
- Sponsor type
- Research network
- Investigators
- Chris Starr, MD, Principal investigator, The New York Presbyterian Hospital Weill Cornell Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570843
- Sponsor's protocol ID
- 0710009485
- Status last verified
- Feb 2010
- First submitted
- 7 Dec 2007
- Last updated
- 22 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Masked Comparison of a New PEG Based Artificial Tear and Optive for Comfort, Vision & Wear Time in Patients Wearing Contact Lenses
- ClinicalTrials.gov ID
- NCT00570843
- Acronym / sponsor ID
- 0710009485
- Conditions
- Comfort, Vision and Wear Time
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bp Consulting, IncResearch network
- Study start
- Mar 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 11 Dec 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.
The objective of this study is to evaluate the effect of a new PEG based artificial tear as compared to Optive on comfort, wear time, and vision in patients wearing contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. | Active comparator | Drug: New PEG based artificial tear |
| 2. | Placebo comparator | Drug: Optive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Use of soft contact lenses (e.g. silicone hydrogel lenses, daily disposables etc.) and multipurpose solution for cleaning, including enzyme-based cleaners (ClearCare etc.)
- Able to wear contact lenses for approximately 10-12 hours/day
- Willingness to complete entire length of trial and comply with subjective questionnaire.
Key exclusion criteria (4 listed)
- Patients taking topical cyclosporine (Restasis)
- Patients currently using Optive for dryness relief.
- Patients wearing hard or rigid gas permeable lenses
- Patients with uncontrolled systemic disease which may confound the results of the trial.
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 PEG based artificial tear1, 2, (in the eye) Instill one drop in the left eye or right eye four times daily (can be used more frequently if needed) | Drug | 1. |
| Optive1, 2, (in the eye) Instill one drop in the left eye or right eye four times daily (can be used more frequently if needed) | Drug | 2. |
Primary outcome
Comfort
Time frame: 1 month
1 secondary outcome
vision and wear time
Time frame: 1 month
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 22 Feb 2010.
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.
Chris Starr, MD principal investigator
The New York Presbyterian Hospital Weill Cornell Medical College
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 PEG based artificial tear and Optive in people with Comfort, Vision and Wear Time, run by Bp Consulting, Inc 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 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 22 Feb 2010. 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?
Comfort (time frame: 1 month). 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 22 Feb 2010.