AmetropiaNCT00722891
Ocular Responses to Short and Long-term Lens Wear
A study testing Purevision Lenses with ReNu Multiplus and Purevision Lenses with Optifree RepleniSH in people with Ametropia, run by Bausch & Lomb Incorporated at 1 site in Canada.
Trial summary
The purpose of this study was to determine whether ocular surface sensitivity to pneumatic, mechanical and chemical stimulation would be affected by the use of the combination of a specific silicone hydrogel lens material with two lens care products over a four week period. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ametropia
- What is being tested?
- Purevision Lenses with ReNu Multiplus and Purevision Lenses with Optifree RepleniSH
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2008to Sep 2009
- Phase
- Interventional
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Is at least 17 years old and has full legal capacity to volunteer;
- Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction;
- Is a current soft lens wearer and wears contact lenses six or more days/week;
- Has clear corneas and no active ocular disease.
Who cannot join
- Has any clinically significant blepharitis or dry eye;
- Has undergone corneal refractive surgery;
- Is aphakic;
- Has any active ocular disease;
- Has any systemic disease affecting ocular health;
- Is using any systemic or topical medications that may affect ocular health;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ocular Responses to Acute and Chronic Lens Wear
The purpose of this study was to determine whether ocular surface sensitivity to pneumatic, mechanical and chemical stimulation would be affected by the use of the combination of a specific silicone hydrogel lens material with two lens care products over a four week period.
- Conditions
- Ametropia
- Being tested
- Purevision Lenses with ReNu Multiplus, Purevision Lenses with Optifree RepleniSH
- Keywords
- Eye Diseases
- Medical subject headings
- Refractive Errors, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purevision Lenses with ReNu MultiplusDevice
Also called Balafilcon A
Purevision lenses using ReNu Multiplus lens solution for 28 days
Purevision Lenses with Optifree RepleniSHDevice
Also called Balafilcon A
Purevision lenses using Optifree RepleniSH lens solution for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Purevision Lens with ReNu | Active comparator | Purevision Lenses with ReNu Multiplus Solution Receives: Device: Purevision Lenses with ReNu Multiplus |
| Purevision Lenses with RepleniSH | Active comparator | Purevision Lenses with Optifree RepleniSH Solution Receives: Device: Purevision Lenses with Optifree RepleniSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify the ocular response to acute and chronic lens wear using slit lamp examination, tear assay and corneal sensitivity.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmetropiaStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Trefford Simpson, DipOptom,MSc,PhD, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722891
- Sponsor's protocol ID
- P/289/07/B
- Status last verified
- Nov 2019
- First submitted
- 24 Jul 2008
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Responses to Acute and Chronic Lens Wear
- ClinicalTrials.gov ID
- NCT00722891
- Acronym / sponsor ID
- P/289/07/B
- Conditions
- Ametropia
- Keywords
- Eye Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 28 Jul 2008 (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 purpose of this study was to determine whether ocular surface sensitivity to pneumatic, mechanical and chemical stimulation would be affected by the use of the combination of a specific silicone hydrogel lens material with two lens care products over a four week period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Purevision Lens with ReNu | Active comparator | Device: Purevision Lenses with ReNu MultiplusPurevision Lenses with ReNu Multiplus Solution |
| Purevision Lenses with RepleniSH | Active comparator | Device: Purevision Lenses with Optifree RepleniSHPurevision Lenses with Optifree RepleniSH Solution |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Is at least 17 years old and has full legal capacity to volunteer;
- Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction;
- Is a current soft lens wearer and wears contact lenses six or more days/week;
- Has clear corneas and no active ocular disease.
Key exclusion criteria (6 listed)
- Has any clinically significant blepharitis or dry eye;
- Has undergone corneal refractive surgery;
- Is aphakic;
- Has any active ocular disease;
- Has any systemic disease affecting ocular health;
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 |
|---|---|---|
| Purevision Lenses with ReNu MultiplusAlso: Balafilcon APurevision lenses using ReNu Multiplus lens solution for 28 days | Device | Purevision Lens with ReNu |
| Purevision Lenses with Optifree RepleniSHAlso: Balafilcon APurevision lenses using Optifree RepleniSH lens solution for 28 days | Device | Purevision Lenses with RepleniSH |
Primary outcome
Quantify the ocular response to acute and chronic lens wear using slit lamp examination, tear assay and corneal sensitivity.
Time frame: 5 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 26 Nov 2019.
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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.
Trefford Simpson, DipOptom,MSc,PhD principal investigator
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Purevision Lenses with ReNu Multiplus and Purevision Lenses with Optifree RepleniSH in people with Ametropia, run by Bausch & Lomb Incorporated at 1 site in Canada.
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 4 inclusion and 6 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 26 Nov 2019. 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 Canada. 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.
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?
Quantify the ocular response to acute and chronic lens wear using slit lamp examination, tear assay and corneal sensitivity. (time frame: 5 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 26 Nov 2019.