AmetropiaPhase 3NCT00371787
Evaluation of the Performance of Non-molded Soft Contact Lenses
A Phase 3 study testing Soft contact lens in people with Ametropia, run by University of Waterloo at 1 site in Canada.
Trial summary
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties. 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?
- Soft contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2006to Dec 2007
- Phase
- Phase 3
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
- Male or female, good health, age >17yrs, able to wear contact lenses as primary vision correction, able to see well and achieve good fit with study lens, has understood \& signed consent form.
Who cannot join
- Has active ocular disease, uses topical eye medication, wears gas permeable/silicone hydrogel /overnight wear contact lenses, is a participant in another clinical study, is deemed unsuitable for soft contact lens wear.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Contact Lens Research, University of Waterloo,
Waterloo, Ontario, N2L 3G1
About this study
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties.
Read the detailed description
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties in a group of participants who present with lens related changes.
- Conditions
- Ametropia
- Being tested
- Soft contact lens
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft contact lensDevice
Also called Custom O2Optix
Soft contact lens
| Study group | Role | What they receive |
|---|---|---|
| soft contact lens | Experimental | Not described Receives: Device: Soft contact lens |
| non-lens wear | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
Measured: baseline
Visual Acuity
level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
Measured: 9 month
Neovascularisation
length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
Measured: baseline
Neovascularization
length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startAug 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- CIBA VISION
- Investigators
- Desmond Fonn, Principal investigator, Centre for Contact Lens Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371787
- Sponsor's protocol ID
- P/240/06/CV
- Status last verified
- Jan 2011
- First submitted
- 1 Sep 2006
- Last updated
- 10 Jan 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No