HyperopiaPhase 4NCT03881670
On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours
A Phase 4 study testing Lotrafilcon B and lotrafilcon B with Hydraluxe in people with Hyperopia and Myopia, run by Indiana University at 1 site in United States.
Trial summary
The current study aims to systematically investigate the diurnal variation in the optical quality of soft contact lenses on eye throughout the day. Subject reported quality of vision will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- What is being tested?
- Lotrafilcon B and lotrafilcon B with Hydraluxe
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2018to 8 Feb 2019
- Phase
- Phase 4
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Habitual prescription +5.00 D to -6.00 D
- 18-35 years of age
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Vertex corrected refractive cylinder must be -0.75 or less.
- Visual acuity best correctable to 20/25 or better for each eye
- The subject must read and sign the Informed Consent form.
- Mesopic pupil size >5.00 mm.
Who cannot join
- active condition that would prevent contact lens wear
- history of issues of eye alignment or binocularity by self-report
- doctor diagnosed, self-reported accommodative or binocular vision issues
- doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Clinical Optics Research Lab
Bloomington, Indiana, 47405
About this study
The current study aims to systematically investigate the diurnal variation in the optical quality of soft contact lenses on eye throughout the day. Subject reported quality of vision will also be evaluated.
- Being tested
- Lotrafilcon B, lotrafilcon B with Hydraluxe
- Medical subject headings
- Hyperopia, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lotrafilcon BDevice
commercially available contact lens
lotrafilcon B with HydraluxeDevice
commercially available contact lens
| Study group | Role | What they receive |
|---|---|---|
| Lotrafilcon B | Placebo comparator | Not described Receives: Device: Lotrafilcon B; Device: lotrafilcon B with Hydraluxe |
| Lotrafilcon B Hydraluxe | Active comparator | Not described Receives: Device: Lotrafilcon B; Device: lotrafilcon B with Hydraluxe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Higher Order Aberrations
Higher-order Root Mean Squared (RMS) over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects
Measured: 0-12 hours
Secondary outcomes (2)
Subjective Stability of Vision Rating
Subjects are asked to rate their stability of vision on a numeric rating scale (0, poor to 100 excellent) (Kollbaum 2012). The difference between time 0 and time 12 hours is reported for all subjects (negative number represents a decrease in stability of vision)
Measured: 0-12 hours
Image Quality Metrics
Root Mean Squared (RMS) wavefront error over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects
Measured: 0-12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start7 Dec 2018
- Primary completion8 Feb 2019
- Study completion8 Feb 2019
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 HyperopiaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Pete Kollbaum, OD, PhD, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881670
- Sponsor's protocol ID
- Kollbaum002
- Status last verified
- Mar 2020
- First submitted
- 27 Feb 2019
- Last updated
- 10 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours
- ClinicalTrials.gov ID
- NCT03881670
- Acronym / sponsor ID
- Kollbaum002
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 8 Feb 2019 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Posted 24 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study aims to systematically investigate the diurnal variation in the optical quality of soft contact lenses on eye throughout the day. Subject reported quality of vision will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lotrafilcon B | Placebo comparator | Device: Lotrafilcon B, Device: lotrafilcon B with Hydraluxe |
| Lotrafilcon B Hydraluxe | Active comparator | Device: Lotrafilcon B, Device: lotrafilcon B with Hydraluxe |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Habitual prescription +5.00 D to -6.00 D
- 18-35 years of age
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Vertex corrected refractive cylinder must be -0.75 or less.
- Visual acuity best correctable to 20/25 or better for each eye
Key exclusion criteria (4 listed)
- active condition that would prevent contact lens wear
- history of issues of eye alignment or binocularity by self-report
- doctor diagnosed, self-reported accommodative or binocular vision issues
- doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment
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 Bcommercially available contact lens | Device | Lotrafilcon B, Lotrafilcon B Hydraluxe |
| lotrafilcon B with Hydraluxecommercially available contact lens | Device | Lotrafilcon B, Lotrafilcon B Hydraluxe |
Primary outcome
Higher Order Aberrations
Time frame: 0-12 hours
Higher-order Root Mean Squared (RMS) over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects
2 secondary outcomes
Subjective Stability of Vision Rating
Time frame: 0-12 hours
Image Quality Metrics
Time frame: 0-12 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lotrafilcon B and lotrafilcon B with Hydraluxe in people with Hyperopia and Myopia, run by Indiana University 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 7 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 10 Mar 2020. 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?
Yes. Results are posted in the registry (first posted 24 Feb 2020). 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?
Higher Order Aberrations (time frame: 0-12 hours). 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 10 Mar 2020.