PresbyopiaNCT01959178
A Study to Evaluate a Mid Add Multi-Focal Soft Contact Lens
A study testing LD127025 MF and Air Optix Aqua MF in people with Presbyopia, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
This study is to evaluate the product performance of the investigational LD127025 MF mid add soft contact lens compared to CIBA Vision's Air Optix Aqua MF MED add soft contact lenses when used among currently adapted soft contact lens wearers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Presbyopia
- What is being tested?
- LD127025 MF and Air Optix Aqua MF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Aug 2013
- 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
- Have physiologically normal anterior segments not exhibiting biomicroscopy findings Grade 2 or greater and/or presence of infiltrates.
- Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- Be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye.
- Require contact lens correction from -5.00 D to +3.00 D in each eye.
- Be Presbyopic and require near add correction from +1.00 D to +1.75 D in each eye.
- Be an adapted monovision soft contact lens wearer or multifocal soft contact lens wearer or an adapted spherical soft contact lens wearer who also uses spectacles for near vision correction.
- Be willing to use a lens care system as required by the lens replacement schedule.
- Has a distance spherical equivalent refraction between -5.50 D and +3.00 D.
Who cannot join
- Not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
- Participated in any drug or device clinical investigation (within 14 days) prior to entry into this study and/or during the period of study participation.
- Women of childbearing potential if one of the following: pregnant, plans to become pregnant during study, is breast-feeding.
- Any Grade 2 or greater finding during the slit lamp examination. Subjects with corneal infiltrates of ANY GRADE are not eligible.
- Any scar or neovascularization within the central 4mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
- Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Show all 21Show fewer
- Anisometropia (spherical equivalent) of greater than 2.00 D.
- Aphakic.
- Amblyopic.
- Allergic to any component in the study care products.
- Meet any of the following criteria:
- Ophthalmologist, OD, Optician, Ophthalmologist's Assistant/Technician
- employee of a market research firm
- employee of manufacturer of contact lens or contact lens care products
- Ocular astigmatism of greater than 1.00 D in either eye.
- Have had any corneal surgery (ie, refractive surgery).
- Toric contact lens wearer.
- Have worn gas permeable (GP) contact lenses within the last 30 days or PMMA lenses within the last 3 months.
- Have an active ocular disease or are using any ocular medication.
- Have any systemic disease currently affecting ocular health or which, in the Investigator's opinion, may have an effect on ocular health during the course of the study.
- Using any systemic medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bausch & Lomb Incorporated
Rochester, New York, 14609
About this study
This study is to evaluate the product performance of the investigational LD127025 MF mid add soft contact lens compared to CIBA Vision's Air Optix Aqua MF MED add soft contact lenses when used among currently adapted soft contact lens wearers.
- Conditions
- Presbyopia
- Being tested
- LD127025 MF, Air Optix Aqua MF
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LD127025 MFDevice
At Visit 1, one-half of the subjects will be randomized to receive the investigational soft contact lens, after approximately one week of wearing the first lens type, the subjects will return for the 1-Week Crossover Visit (Visit 2) for an exam, and to determine if the subject remains eligible to continue in the next phase of the study with the control soft contact lens.
Air Optix Aqua MFDevice
At Visit 1, one-half of the subjects will be randomized to receive the control soft contact lens, after approximately one week of wearing the first lens type, the subjects will return for the 1-Week Crossover Visit (Visit 2) for an exam, and to determine if the subject remains eligible to continue in the next phase of the study with the investigational soft contact lens.
| Study group | Role | What they receive |
|---|---|---|
| LD127025 MF | Experimental | Mid add daily disposable soft contact lens worn on a daily wear basis for 1 week. Receives: Device: LD127025 MF; Device: Air Optix Aqua MF |
| Air Optix Aqua MF | Active comparator | Medium add daily disposable soft contact lens worn on a daily wear basis for one week. Receives: Device: LD127025 MF; Device: Air Optix Aqua MF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Visual Acuity
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Measured: At 1 Week follow up
Secondary outcomes (1)
Symptoms/Complaints
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.
Measured: At 1 Week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2013
- Study completionAug 2013
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 PresbyopiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Stefffen, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959178
- Sponsor's protocol ID
- 825E
- Status last verified
- Sep 2020
- First submitted
- 8 Oct 2013
- Last updated
- 30 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate a Mid Add Multi-Focal Soft Contact Lens
- ClinicalTrials.gov ID
- NCT01959178
- Acronym / sponsor ID
- 825E
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Posted 30 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the product performance of the investigational LD127025 MF mid add soft contact lens compared to CIBA Vision's Air Optix Aqua MF MED add soft contact lenses when used among currently adapted soft contact lens wearers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LD127025 MF | Experimental | Device: LD127025 MF, Device: Air Optix Aqua MFMid add daily disposable soft contact lens worn on a daily wear basis for 1 week. |
| Air Optix Aqua MF | Active comparator | Device: LD127025 MF, Device: Air Optix Aqua MFMedium add daily disposable soft contact lens worn on a daily wear basis for one week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have physiologically normal anterior segments not exhibiting biomicroscopy findings Grade 2 or greater and/or presence of infiltrates.
- Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- Be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye.
- Require contact lens correction from -5.00 D to +3.00 D in each eye.
- Be Presbyopic and require near add correction from +1.00 D to +1.75 D in each eye.
Key exclusion criteria (21 listed)
- Not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
- Participated in any drug or device clinical investigation (within 14 days) prior to entry into this study and/or during the period of study participation.
- Women of childbearing potential if one of the following: pregnant, plans to become pregnant during study, is breast-feeding.
- Any Grade 2 or greater finding during the slit lamp examination. Subjects with corneal infiltrates of ANY GRADE are not eligible.
- Any scar or neovascularization within the central 4mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
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 |
|---|---|---|
| LD127025 MFAt Visit 1, one-half of the subjects will be randomized to receive the investigational soft contact lens, after approximately one week of wearing the first lens type, the subjects will return for the 1-Week Crossover Visit (Visit 2) for an exam, and to determine if the subject remains eligible to continue in the next phase of the study with the control soft contact lens. | Device | Air Optix Aqua MF, LD127025 MF |
| Air Optix Aqua MFAt Visit 1, one-half of the subjects will be randomized to receive the control soft contact lens, after approximately one week of wearing the first lens type, the subjects will return for the 1-Week Crossover Visit (Visit 2) for an exam, and to determine if the subject remains eligible to continue in the next phase of the study with the investigational soft contact lens. | Device | Air Optix Aqua MF, LD127025 MF |
Primary outcome
Mean Visual Acuity
Time frame: At 1 Week follow up
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
1 secondary outcome
Symptoms/Complaints
Time frame: At 1 Week follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Presbyopia
Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
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.
Robert Stefffen study director
Bausch & Lomb Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LD127025 MF and Air Optix Aqua MF in people with Presbyopia, run by Bausch & Lomb Incorporated 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 8 inclusion and 21 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 30 Sep 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. 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 30 Sep 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?
Mean Visual Acuity (time frame: At 1 Week follow up). 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 30 Sep 2020.