AstigmatismNCT03392532
Comparison of Two Silicone Hydrogel Toric Contact Lenses
A study testing Lotrafilcon B toric contact lenses with HYDRAGLYDE and Lotrafilcon B toric contact lenses in people with Astigmatism, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this research study is to compare the performance of two different types of Alcon soft toric study contact lenses to obtain information on study lens orientation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astigmatism
- What is being tested?
- Lotrafilcon B toric contact lenses with HYDRAGLYDE and Lotrafilcon B toric contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2018to 26 Jan 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Successful wear of soft contact lenses for vision correction in both eyes during the past 3 months for a minimum of 3 days per week and 8 hours per day
- Astigmatism
- Requires contact lenses
- Best corrected visual acuity of 20/25 or better in each eye
- Other protocol-specified inclusion criteria may apply
Who cannot join
- Any eye condition that contraindicates contact lens wear, as determined by the Investigator
- Any eye surgery that contraindicates contact lens wear, as determined by the Investigator
- Other protocol-specified exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Alcon Investigative Site
Johns Creek, Georgia, 30097
About this study
Official title: Axis Orientation Comparison of Two Silicone Hydrogel Toric Contact Lenses
The purpose of this research study is to compare the performance of two different types of Alcon soft toric study contact lenses to obtain information on study lens orientation.
- Conditions
- Astigmatism
- Being tested
- Lotrafilcon B toric contact lenses with HYDRAGLYDE, Lotrafilcon B toric contact lenses
- Keywords
- Astigmatism, Axis orientation
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lotrafilcon B toric contact lenses with HYDRAGLYDEDevice
Also called AIR OPTIX® plus HYDRAGLYDE® for Astigmatism contact lenses, AOHG for Astigmatism
Silicone hydrogel soft contact lenses for astigmatism
Lotrafilcon B toric contact lensesDevice
Also called AIR OPTIX® for Astigmatism contact lenses, AO for Astigmatism
Silicone hydrogel soft contact lenses for astigmatism
| Study group | Role | What they receive |
|---|---|---|
| AOHG toric, then AO toric | Other | Lotrafilcon B toric contact lenses with HYDRAGLYDE, followed by lotrafilcon B toric contact lenses, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2. Receives: Device: Lotrafilcon B toric contact lenses with HYDRAGLYDE; Device: Lotrafilcon B toric contact lenses |
| AO toric, then AOHG toric | Other | Lotrafilcon B toric contact lenses, followed by lotrafilcon B toric contact lenses with HYDRAGLYDE, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2. Receives: Device: Lotrafilcon B toric contact lenses with HYDRAGLYDE; Device: Lotrafilcon B toric contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location)
Each lens was classified based on whether the absolute difference between the axis location and 90° was less than or equal to 30° (ie, lens axis located between the 60° and 120° axis inclusive). Inferential testing was not planned for this primary effectiveness endpoint.
Measured: Day 1, 10 minutes after lens insertion, each product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start4 Jan 2018
- Primary completion26 Jan 2018
- Study completion26 Jan 2018
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.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alcon, A Novartis Division, Study director, Alcon, A Novartis Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392532
- Sponsor's protocol ID
- CLC127-C001
- Status last verified
- Jan 2019
- First submitted
- 2 Jan 2018
- Last updated
- 29 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axis Orientation Comparison of Two Silicone Hydrogel Toric Contact Lenses
- ClinicalTrials.gov ID
- NCT03392532
- Acronym / sponsor ID
- CLC127-C001
- Conditions
- Astigmatism
- Keywords
- Astigmatism, Axis orientation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 26 Jan 2018 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Posted 29 Jan 2019
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 research study is to compare the performance of two different types of Alcon soft toric study contact lenses to obtain information on study lens orientation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AOHG toric, then AO toric | Other | Device: Lotrafilcon B toric contact lenses with HYDRAGLYDE, Device: Lotrafilcon B toric contact lensesLotrafilcon B toric contact lenses with HYDRAGLYDE, followed by lotrafilcon B toric contact lenses, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2. |
| AO toric, then AOHG toric | Other | Device: Lotrafilcon B toric contact lenses with HYDRAGLYDE, Device: Lotrafilcon B toric contact lensesLotrafilcon B toric contact lenses, followed by lotrafilcon B toric contact lenses with HYDRAGLYDE, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Successful wear of soft contact lenses for vision correction in both eyes during the past 3 months for a minimum of 3 days per week and 8 hours per day
- Astigmatism
- Requires contact lenses
- Best corrected visual acuity of 20/25 or better in each eye
- Other protocol-specified inclusion criteria may apply
Key exclusion criteria (3 listed)
- Any eye condition that contraindicates contact lens wear, as determined by the Investigator
- Any eye surgery that contraindicates contact lens wear, as determined by the Investigator
- Other protocol-specified exclusion criteria may apply
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 |
|---|---|---|
| Lotrafilcon B toric contact lenses with HYDRAGLYDEAlso: AIR OPTIX® plus HYDRAGLYDE® for Astigmatism contact lenses, AOHG for AstigmatismSilicone hydrogel soft contact lenses for astigmatism | Device | AO toric, then AOHG toric, AOHG toric, then AO toric |
| Lotrafilcon B toric contact lensesAlso: AIR OPTIX® for Astigmatism contact lenses, AO for AstigmatismSilicone hydrogel soft contact lenses for astigmatism | Device | AO toric, then AOHG toric, AOHG toric, then AO toric |
Primary outcome
Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location)
Time frame: Day 1, 10 minutes after lens insertion, each product
Each lens was classified based on whether the absolute difference between the axis location and 90° was less than or equal to 30° (ie, lens axis located between the 60° and 120° axis inclusive). Inferential testing was not planned for this primary effectiveness endpoint.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Alcon, A Novartis Division study director
Alcon, A Novartis Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lotrafilcon B toric contact lenses with HYDRAGLYDE and Lotrafilcon B toric contact lenses in people with Astigmatism, run by Alcon Research 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 3 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 29 Jan 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 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 29 Jan 2019). 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?
Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location) (time frame: Day 1, 10 minutes after lens insertion, each product). 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 29 Jan 2019.