AstigmatismNCT01120782
Non-dispensing Study to Check Prescription Equivalence of Two Daily Disposable Toric Contact Lens Types
A study testing etafilcon A toric contact lens with new wetting agent and etafilcon A toric contact lens in people with Astigmatism, run by Johnson & Johnson Vision Care, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether the prescription determined for a new daily disposable toric contact lens will be a good match to a prescription determined for an existing brand of lens. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Astigmatism
- What is being tested?
- etafilcon A toric contact lens with new wetting agent and etafilcon A toric contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2010to 1 Feb 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The subject must be between 18 and 40 years old.
- The subject must have normal eyes.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.
- The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00 DS in each eye.
- The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.
Show all 10Show fewer
- The subject's refractive cylinder axis must be 180 +/- 30 in each eye.
- The subject must be an adapted wearer of soft toric contact lenses in both eyes.
- The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye.
- Subjects must already possess a wearable pair of spectacles. -
Who cannot join
- Ocular or systemic allergies or disease that may interfere with contact lens wear.
- Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear.
- Clinically significant corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
- Clinically significant tarsal abnormalities that might interfere with contact lens wear.
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
Show all 10Show fewer
- Pregnancy or lactation
- Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
- Diabetes
- Strabismus -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Jacksonville, Florida
Study site
New York, New York
About this study
The purpose of this study is to determine whether the prescription determined for a new daily disposable toric contact lens will be a good match to a prescription determined for an existing brand of lens.
- Conditions
- Astigmatism
- Being tested
- etafilcon A toric contact lens with new wetting agent, etafilcon A toric contact lens
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etafilcon A toric contact lens with new wetting agentDevice
Investigational toric contact lens made of etafilcon A material with a new wetting agent.
etafilcon A toric contact lensDevice
Marketed toric contact lens made of etafilcon A material.
| Study group | Role | What they receive |
|---|---|---|
| etafilcon A toric new lens/etafilcon A toric lens | Active comparator | The lens worn first is a new etafilcon A toric contact lens and the lens worn second is a marketed etafilcon A toric contact lens. Each lens worn for a maximum of 15 minutes bilaterally. Receives: Device: etafilcon A toric contact lens with new wetting agent; Device: etafilcon A toric contact lens |
| etafilcon A toric lens/etafilcon A toric new lens | Active comparator | The lens worn first is a marketed etafilcon A toric contact lens and the lens worn second is a new etafilcon A toric contact lens. Each lens worn for a maximum of 15 minutes bilaterally. Receives: Device: etafilcon A toric contact lens with new wetting agent; Device: etafilcon A toric contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescription Equivalence
Number of subjects whose prescription is the same for the two lenses tested.
Measured: after 15 minutes of lens wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study start1 Feb 2010
- Primary completion1 Feb 2010
- Study completion1 Feb 2010
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 AstigmatismStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120782
- Sponsor's protocol ID
- CR-1476AI
- Status last verified
- Sep 2017
- First submitted
- 4 May 2010
- Last updated
- 19 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-dispensing Study to Check Prescription Equivalence of Two Daily Disposable Toric Contact Lens Types
- ClinicalTrials.gov ID
- NCT01120782
- Acronym / sponsor ID
- CR-1476AI
- Conditions
- Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2010 (actual)
- Primary completion
- 1 Feb 2010 (actual)
- Study completion
- 1 Feb 2010 (actual)
- First posted
- 11 May 2010 (estimated)
- Results
- Posted 8 Dec 2011
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 is to determine whether the prescription determined for a new daily disposable toric contact lens will be a good match to a prescription determined for an existing brand of lens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| etafilcon A toric new lens/etafilcon A toric lens | Active comparator | Device: etafilcon A toric contact lens with new wetting agent, Device: etafilcon A toric contact lensThe lens worn first is a new etafilcon A toric contact lens and the lens worn second is a marketed etafilcon A toric contact lens. Each lens worn for a maximum of 15 minutes bilaterally. |
| etafilcon A toric lens/etafilcon A toric new lens | Active comparator | Device: etafilcon A toric contact lens with new wetting agent, Device: etafilcon A toric contact lensThe lens worn first is a marketed etafilcon A toric contact lens and the lens worn second is a new etafilcon A toric contact lens. Each lens worn for a maximum of 15 minutes bilaterally. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- The subject must be between 18 and 40 years old.
- The subject must have normal eyes.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.
- The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00 DS in each eye.
Key exclusion criteria (10 listed)
- Ocular or systemic allergies or disease that may interfere with contact lens wear.
- Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear.
- Clinically significant corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
- Clinically significant tarsal abnormalities that might interfere with contact lens wear.
- Any ocular infection.
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 |
|---|---|---|
| etafilcon A toric contact lens with new wetting agentInvestigational toric contact lens made of etafilcon A material with a new wetting agent. | Device | etafilcon A toric lens/etafilcon A toric new lens, etafilcon A toric new lens/etafilcon A toric lens |
| etafilcon A toric contact lensMarketed toric contact lens made of etafilcon A material. | Device | etafilcon A toric lens/etafilcon A toric new lens, etafilcon A toric new lens/etafilcon A toric lens |
Primary outcome
Prescription Equivalence
Time frame: after 15 minutes of lens wear
Number of subjects whose prescription is the same for the two lenses tested.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Astigmatism
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing etafilcon A toric contact lens with new wetting agent and etafilcon A toric contact lens in people with Astigmatism, run by Johnson & Johnson Vision Care, Inc. at 2 sites 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 10 inclusion and 10 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 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Prescription Equivalence (time frame: after 15 minutes of lens wear). 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 19 Jun 2018.