AsthenopiaNCT03544216
Accommodative Relief for Uncomfortable Non-Presbyopes
A study testing Multifocal Contact Lens and Single Vision Contact Lens in people with Asthenopia, run by Ohio State University at 1 site in United States.
Trial summary
This study will determine how multifocal contact lens correction affects symptoms of discomfort and asthenopia in a group of myopic contact lens wearers in the non-presbyopic age range (ages 30-40 years). Read more about this study
- Who is it for?
- Ages 30 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthenopia
- What is being tested?
- Multifocal Contact Lens and Single Vision Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2017to 6 May 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 30 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Visual acuity of 20/25 or better in both eyes with habitual contact lenses
- -0.75 D or more myopic in both eyes
- -0.75 D or less astigmatism in both eyes
- Current single vision contact lens wearer who does not require a reading aid
- CLDEQ-8 score of 12 or more points with habitual contact lenses
- No history of ocular surgery or medication
Show all 9Show fewer
- Reports digital device use of at least 3 hours per day
- No significant signs of dry eye (grade 1 or less ocular surface staining, Schirmer score of 7 mm or more, and tear break up time of 7 seconds or more in bother eyes)
- No significant binocular vision disorders in both eyes (eso or exophoria of 4 prism diopters or less at distance and near, near point of convergence of 6 mm or less, no history of strabismus or patching)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Optometry
Columbus, Ohio, 43210
About this study
This study will determine how multifocal contact lens correction affects symptoms of discomfort and asthenopia in a group of myopic contact lens wearers in the non-presbyopic age range (ages 30-40 years).
Read the detailed description
The purpose of this study is to determine how multifocal contact lenses affect contact lens comfort in non-presbyopic contact lens wearers. Current soft contact lens wearers who have symptoms of discomfort in their contact lenses will be recruited. Each subject (n = 84) will wear a single vision soft contact lens (Ultra single vision spherical lens) for two weeks and a low add power multifocal (Ultra for Presbyopia) for two weeks. Half of the subjects will wear the single vision lens first, and half of the subjects will wear the multifocal lens first. Initial lens group will be chosen randomly. Subjects will complete surveys that assess their vision and comfort which each lens, and ocular surface and accommodative/binocular vision status will be evaluated at the initial dispense and after wearing each lens for two weeks.
- Conditions
- Asthenopia
- Being tested
- Multifocal Contact Lens, Single Vision Contact Lens
- Keywords
- Contact Lens, Multifocal, Accommodation, Presbyopia
- Medical subject headings
- Asthenopia, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifocal Contact LensDevice
The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks
Single Vision Contact LensDevice
The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Single Vision First | Experimental | Subjects in this group will receive the single vision spherical (Bausch + Lomb ULTRA®) lens for the first two weeks and be crossed over to the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lens for the second two weeks.Therefore, this group will receive both study interventions. Receives: Device: Multifocal Contact Lens; Device: Single Vision Contact Lens |
| Multifocal first | Experimental | Subjects in this group will receive the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lenses for the first two weeks and be crossed over to the single vision spherical (Bausch + Lomb ULTRA®) lens for the second two weeks. Therefore, this group will receive both study interventions. Receives: Device: Multifocal Contact Lens; Device: Single Vision Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score
After wearing each lens type (single vision and multifocal) for 2 weeks, subjects will complete the CLDEQ-8, a survey that assesses symptoms of contact lens discomfort, to reports their symptoms of discomfort with each lens type. CLDEQ-8 scores with the multifocal will be compared to CLDEQ-8 scores of the single vision lens and the subjects' habitual contact lenses to determine if the multifocal improved comfort.
Min-Max CLDEQ-8 range: 0-37 points Higher point values indicate more/worse symptoms
Measured: Baseline and after 2 weeks of contact lens wear with each study lens (single vision and multifocal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start2 Feb 2017
- Primary completion6 May 2018
- Study completion6 May 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 AsthenopiaStudies of the same condition, open and under way.
- More trials run by Ohio State 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Responsible party
- Principal investigator, Erin Rueff, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544216
- Sponsor's protocol ID
- 2016H0382-60058303
- Status last verified
- Jan 2019
- First submitted
- 12 Jan 2017
- Last updated
- 15 Feb 2019
- 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 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accommodative Relief for Uncomfortable Non-Presbyopes
- ClinicalTrials.gov ID
- NCT03544216
- Acronym / sponsor ID
- 2016H0382-60058303
- Conditions
- Asthenopia
- Keywords
- Contact Lens, Multifocal, Accommodation, Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 6 May 2018 (actual)
- Study completion
- 6 May 2018 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine how multifocal contact lens correction affects symptoms of discomfort and asthenopia in a group of myopic contact lens wearers in the non-presbyopic age range (ages 30-40 years).
Detailed description
The purpose of this study is to determine how multifocal contact lenses affect contact lens comfort in non-presbyopic contact lens wearers. Current soft contact lens wearers who have symptoms of discomfort in their contact lenses will be recruited. Each subject (n = 84) will wear a single vision soft contact lens (Ultra single vision spherical lens) for two weeks and a low add power multifocal (Ultra for Presbyopia) for two weeks. Half of the subjects will wear the single vision lens first, and half of the subjects will wear the multifocal lens first. Initial lens group will be chosen randomly. Subjects will complete surveys that assess their vision and comfort which each lens, and ocular surface and accommodative/binocular vision status will be evaluated at the initial dispense and after wearing each lens for two weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Vision First | Experimental | Device: Multifocal Contact Lens, Device: Single Vision Contact LensSubjects in this group will receive the single vision spherical (Bausch + Lomb ULTRA®) lens for the first two weeks and be crossed over to the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lens for the second two weeks.Therefore, this group will receive both study interventions. |
| Multifocal first | Experimental | Device: Multifocal Contact Lens, Device: Single Vision Contact LensSubjects in this group will receive the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lenses for the first two weeks and be crossed over to the single vision spherical (Bausch + Lomb ULTRA®) lens for the second two weeks. Therefore, this group will receive both study interventions. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Visual acuity of 20/25 or better in both eyes with habitual contact lenses
- -0.75 D or more myopic in both eyes
- -0.75 D or less astigmatism in both eyes
- Current single vision contact lens wearer who does not require a reading aid
- CLDEQ-8 score of 12 or more points with habitual contact lenses
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Multifocal Contact LensThe multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks | Device | Multifocal first, Single Vision First |
| Single Vision Contact LensThe single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks | Device | Multifocal first, Single Vision First |
Primary outcome
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score
Time frame: Baseline and after 2 weeks of contact lens wear with each study lens (single vision and multifocal)
After wearing each lens type (single vision and multifocal) for 2 weeks, subjects will complete the CLDEQ-8, a survey that assesses symptoms of contact lens discomfort, to reports their symptoms of discomfort with each lens type. CLDEQ-8 scores with the multifocal will be compared to CLDEQ-8 scores of the single vision lens and the subjects' habitual contact lenses to determine if the multifocal improved comfort. Min-Max CLDEQ-8 range: 0-37 points Higher point values indicate more/worse symptoms
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 study testing Multifocal Contact Lens and Single Vision Contact Lens in people with Asthenopia, run by Ohio State 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 9 inclusion and 0 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 15 Feb 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 15 Feb 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?
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score (time frame: Baseline and after 2 weeks of contact lens wear with each study lens (single vision and multifocal)). 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 15 Feb 2019; AzTrials last refreshed its copy on 27 Oct 2026.