Contact Lens ComfortCLANNCT02148263
Contact Lens Adaptation in Neophytes
A study testing senofilcon A in people with Contact Lens Comfort, run by Ohio State University at 1 site in United States.
Trial summary
Eye care professionals prescribe contact lenses to new wearers on a daily basis, and it is common practice for practitioners to educate their patients to gradually increase their contact lens wear time over their first few days of use; however, there is no scientific basis in the literature for this practice. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Contact Lens Comfort
- What is being tested?
- senofilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 3 Sep 2019
- 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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Has had a completed comprehensive eye exam within the past 6 months
- Able to wear spherical senofilcon A contact lenses
- Able to use Opti-Free PureMoist contact lens solution
Who cannot join
- Any prior contact lens use
- Topical eye drops within the last two hours of the study visit
- Known systemic health conditions known to alter tear film physiology
- History of severe ocular trauma
- Active ocular infection
- Active ocular inflammation
- Known hypersensitivity to diagnostic eye drops
- Pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Eye care professionals prescribe contact lenses to new wearers on a daily basis, and it is common practice for practitioners to educate their patients to gradually increase their contact lens wear time over their first few days of use; however, there is no scientific basis in the literature for this practice. This study will compare the ocular health and comfort of new contact lens wearers who are randomly assigned to begin contact lens wear with increasing wearing time versus those who immediately start full-time wear (eight hours or more/day). The increasing wearing time group will wear daily wear contact lenses (Acuvue Oasys) for two, four, six, eight, and eight or more hours on the first, second, third, fourth, and fifth days, respectively. The other group will be instructed to wear the same contact lenses for eight or more hours per day, starting with the first day of wear. Both groups of subjects will have their eye health and comfort evaluated at baseline, one, and two weeks with a lighted-microscope and eye comfort surveys. Subjects will also keep a daily log of eye comfort with a visual analog scale survey at home. All subjects will learn how to wear and take care of contact lenses. They will also receive a prescription for contact lenses at the conclusion if they wish to continue wearing the study contact lenses.
- Conditions
- Contact Lens Comfort
- Being tested
- senofilcon A
- Keywords
- Contact Lenses, Neophytes, Contact Lens Adaptation, Randomized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
senofilcon ADevice
Also called Acuvue Oasys
| Study group | Role | What they receive |
|---|---|---|
| Full-Time Senofilcon A Contact Lens Wear | Experimental | This group will start wearing contact lenses 8 or more hours per day on the first day of wear Receives: Device: senofilcon A |
| Graduated Senofilcon A Contact Lens Wear | Experimental | This group will start wearing contact lenses on a graduated schedule (day 1 = 2 hours, day 2 = 4 hours, day 3 = 6 hours, day 4 = 8 hours, day 5 = 8 or more hours). Receives: Device: senofilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-Group Difference in Eye Comfort as Measured by the Ocular Surface Disease Index (OSDI)
This is an eye comfort survey. The Ocular Surface Disease Index (OSDI) is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.
Measured: 2 weeks
Secondary outcomes (9)
Between-Group Difference in Visual Acuity as Measured With the Bailey-Lovie Chart
The investigator will measure the subject's visual acuity with a Bailey-Lovie high-contrast paper (logMAR) chart. logMAR is a method used to observe visual acuity. Smaller numbers are better scores.
Measured: 2 weeks
Between-Group Difference in Tear Stability as Measured by Non-Invasive Break Up Time (NIBUT)
Non-Invasive Break Up Time (NIBUT) is a measure of tear stability. The range is 0 to 60 seconds with longer times being better tear stability.
Measured: 2 Weeks
Between-Group Difference in Tear Volume as Measured by Tear Meniscus Height (TMH)
Tear Meniscus Height (TMH) was used at a measure of tear volume. The range is 0.0 to 2.0 mm with higher values being more tear volume.
Measured: 2 Weeks
Between-Group Difference in Bulbar Conjunctival Redness as Measured With the Keratograph 5M
Eye redness was measured via bulbar conjunctival redness as measured with the Keratograph 5M. The range is 0 to 4 units with lower numbers being better.
Measured: 2 Weeks
Between-Group Difference in Upper and Lower Eyelid Blepharitis
A slit-lamp biomicroscope was used to document eyelid blepharitis with a 0-3 scale by each eyelid with higher scores being worse blepharitis.
Measured: 2 Weeks
Between-Group Difference in Corneal Sodium Fluorescein Staining
The Brien Holden Vision Institute grading scale was used to evaluate staining by observing the eye after applying sodium fluorescein. Scores were given for the extent (0-20 units), depth (0-20 units), type (0-20 units) of staining. Higher scores indicate worse staining.
Measured: 2 Weeks
Between-Group Difference in Tear Volume as Measured by Schirmer's Test I
Tear volume was assessed with Schirmer's Test I test over 5 mins. This test has a 0-35 mm range with higher values being better tear volume.
Measured: 2 Weeks
Between-Group Difference in End of Day Contact Lens Comfort as Measured With a Visual Analog Scale (VAS)
End of day contact lens comfort was measured with a visual analog scale (1-100 scale). Higher scores indicate better comfort.
Measured: 2 Weeks
Between-Group Difference in Contact Lens Dry Eye-8 Questionnaire (CLDEQ-8) Scores
Contact lens comfort was measured with a scale (1-37 scale). Lower scores indicate better comfort.
Measured: 2-Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startMay 2014
- Primary completion20 Aug 2019
- Study completion3 Sep 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.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Contact Lens ComfortStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Eye Institute (NEI)
- Responsible party
- Principal investigator, Andrew Pucker, Ohio State University
- Investigators
- Andrew D Pucker, OD, MS, Principal investigator, Ohio State UniversityJeffrey J Walline, OD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148263
- Sponsor's protocol ID
- 2014H0074
- Other IDs
- K08EY023264
- Acronym
- CLAN
- Status last verified
- Sep 2022
- First submitted
- 21 May 2014
- Last updated
- 29 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sullivan BD, Whitmer D, Nichols KK, Tomlinson A, Foulks GN, Geerling G, Pepose JS, Kosheleff V, Porreco A, Lemp MA. An objective approach to dry eye disease severity. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6125-30. doi: 10.1167/iovs.10-5390. Epub 2010 Jul 14.
PubMed 20631232Sullivan BD, Crews LA, Sonmez B, de la Paz MF, Comert E, Charoenrook V, de Araujo AL, Pepose JS, Berg MS, Kosheleff VP, Lemp MA. Clinical utility of objective tests for dry eye disease: variability over time and implications for clinical trials and disease management. Cornea. 2012 Sep;31(9):1000-8. doi: 10.1097/ICO.0b013e318242fd60.
PubMed 22475641Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003 Oct;22(7):640-50. doi: 10.1097/00003226-200310000-00008.
PubMed 14508260Yang SN, Tai YC, Sheedy JE, Kinoshita B, Lampa M, Kern JR. Comparative effect of lens care solutions on blink rate, ocular discomfort and visual performance. Ophthalmic Physiol Opt. 2012 Sep;32(5):412-20. doi: 10.1111/j.1475-1313.2012.00922.x. Epub 2012 Jul 7.
PubMed 22775005Dougherty BE, Nichols JJ, Nichols KK. Rasch analysis of the Ocular Surface Disease Index (OSDI). Invest Ophthalmol Vis Sci. 2011 Nov 7;52(12):8630-5. doi: 10.1167/iovs.11-8027.
PubMed 21948646Chalmers RL, Begley CG. Dryness symptoms among an unselected clinical population with and without contact lens wear. Cont Lens Anterior Eye. 2006 Mar;29(1):25-30. doi: 10.1016/j.clae.2005.12.004. Epub 2006 Jan 31.
PubMed 16448840Faber E, Golding TR, Lowe R, Brennan NA. Effect of hydrogel lens wear on tear film stability. Optom Vis Sci. 1991 May;68(5):380-4. doi: 10.1097/00006324-199105000-00010.
PubMed 1852401Efron N, Morgan PB, Katsara SS. Validation of grading scales for contact lens complications. Ophthalmic Physiol Opt. 2001 Jan;21(1):17-29.
PubMed 11220037Pucker AD, Steele K, Rueff E, Franklin QX, McClure K, Savla K, Walline JJ. Contact Lens Adaption in Neophytes. Optom Vis Sci. 2021 Mar 1;98(3):266-271. doi: 10.1097/OPX.0000000000001662.
PubMed 33771956
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contact Lens Adaptation in Neophytes
- ClinicalTrials.gov ID
- NCT02148263
- Acronym / sponsor ID
- CLAN / 2014H0074
- Conditions
- Contact Lens Comfort
- Keywords
- Contact Lenses, Neophytes, Contact Lens Adaptation, Randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Eye Institute (NEI)
- Study start
- May 2014 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Posted 22 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eye care professionals prescribe contact lenses to new wearers on a daily basis, and it is common practice for practitioners to educate their patients to gradually increase their contact lens wear time over their first few days of use; however, there is no scientific basis in the literature for this practice. This study will compare the ocular health and comfort of new contact lens wearers who are randomly assigned to begin contact lens wear with increasing wearing time versus those who immediately start full-time wear (eight hours or more/day). The increasing wearing time group will wear daily wear contact lenses (Acuvue Oasys) for two, four, six, eight, and eight or more hours on the first, second, third, fourth, and fifth days, respectively. The other group will be instructed to wear the same contact lenses for eight or more hours per day, starting with the first day of wear. Both groups of subjects will have their eye health and comfort evaluated at baseline, one, and two weeks with a lighted-microscope and eye comfort surveys. Subjects will also keep a daily log of eye comfort with a visual analog scale survey at home. All subjects will learn how to wear and take care of contact lenses. They will also receive a prescription for contact lenses at the conclusion if they wish to continue wearing the study contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full-Time Senofilcon A Contact Lens Wear | Experimental | Device: senofilcon AThis group will start wearing contact lenses 8 or more hours per day on the first day of wear |
| Graduated Senofilcon A Contact Lens Wear | Experimental | Device: senofilcon AThis group will start wearing contact lenses on a graduated schedule (day 1 = 2 hours, day 2 = 4 hours, day 3 = 6 hours, day 4 = 8 hours, day 5 = 8 or more hours). |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Has had a completed comprehensive eye exam within the past 6 months
- Able to wear spherical senofilcon A contact lenses
- Able to use Opti-Free PureMoist contact lens solution
Key exclusion criteria (8 listed)
- Any prior contact lens use
- Topical eye drops within the last two hours of the study visit
- Known systemic health conditions known to alter tear film physiology
- History of severe ocular trauma
- Active 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 |
|---|---|---|
| senofilcon AAlso: Acuvue Oasys | Device | Full-Time Senofilcon A Contact Lens Wear, Graduated Senofilcon A Contact Lens Wear |
Primary outcome
Between-Group Difference in Eye Comfort as Measured by the Ocular Surface Disease Index (OSDI)
Time frame: 2 weeks
This is an eye comfort survey. The Ocular Surface Disease Index (OSDI) is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.
9 secondary outcomes
Between-Group Difference in Visual Acuity as Measured With the Bailey-Lovie Chart
Time frame: 2 weeks
Between-Group Difference in Tear Stability as Measured by Non-Invasive Break Up Time (NIBUT)
Time frame: 2 Weeks
Between-Group Difference in Tear Volume as Measured by Tear Meniscus Height (TMH)
Time frame: 2 Weeks
Between-Group Difference in Bulbar Conjunctival Redness as Measured With the Keratograph 5M
Time frame: 2 Weeks
Between-Group Difference in Upper and Lower Eyelid Blepharitis
Time frame: 2 Weeks
Between-Group Difference in Corneal Sodium Fluorescein Staining
Time frame: 2 Weeks
Between-Group Difference in Tear Volume as Measured by Schirmer's Test I
Time frame: 2 Weeks
Between-Group Difference in End of Day Contact Lens Comfort as Measured With a Visual Analog Scale (VAS)
Time frame: 2 Weeks
Between-Group Difference in Contact Lens Dry Eye-8 Questionnaire (CLDEQ-8) Scores
Time frame: 2-Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20631232Sullivan BD, Whitmer D, Nichols KK, Tomlinson A, Foulks GN, Geerling G, Pepose JS, Kosheleff V, Porreco A, Lemp MA. An objective approach to dry eye disease severity. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6125-30. doi: 10.1167/iovs.10-5390. Epub 2010 Jul 14.
- Background: PubMed 22475641Sullivan BD, Crews LA, Sonmez B, de la Paz MF, Comert E, Charoenrook V, de Araujo AL, Pepose JS, Berg MS, Kosheleff VP, Lemp MA. Clinical utility of objective tests for dry eye disease: variability over time and implications for clinical trials and disease management. Cornea. 2012 Sep;31(9):1000-8. doi: 10.1097/ICO.0b013e318242fd60.
- Background: PubMed 14508260Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003 Oct;22(7):640-50. doi: 10.1097/00003226-200310000-00008.
- Background: PubMed 22775005Yang SN, Tai YC, Sheedy JE, Kinoshita B, Lampa M, Kern JR. Comparative effect of lens care solutions on blink rate, ocular discomfort and visual performance. Ophthalmic Physiol Opt. 2012 Sep;32(5):412-20. doi: 10.1111/j.1475-1313.2012.00922.x. Epub 2012 Jul 7.
- Background: PubMed 21948646Dougherty BE, Nichols JJ, Nichols KK. Rasch analysis of the Ocular Surface Disease Index (OSDI). Invest Ophthalmol Vis Sci. 2011 Nov 7;52(12):8630-5. doi: 10.1167/iovs.11-8027.
- Background: PubMed 16448840Chalmers RL, Begley CG. Dryness symptoms among an unselected clinical population with and without contact lens wear. Cont Lens Anterior Eye. 2006 Mar;29(1):25-30. doi: 10.1016/j.clae.2005.12.004. Epub 2006 Jan 31.
- Background: PubMed 1852401Faber E, Golding TR, Lowe R, Brennan NA. Effect of hydrogel lens wear on tear film stability. Optom Vis Sci. 1991 May;68(5):380-4. doi: 10.1097/00006324-199105000-00010.
- Background: PubMed 11220037Efron N, Morgan PB, Katsara SS. Validation of grading scales for contact lens complications. Ophthalmic Physiol Opt. 2001 Jan;21(1):17-29.
- Derived from this study: PubMed 33771956Pucker AD, Steele K, Rueff E, Franklin QX, McClure K, Savla K, Walline JJ. Contact Lens Adaption in Neophytes. Optom Vis Sci. 2021 Mar 1;98(3):266-271. doi: 10.1097/OPX.0000000000001662.
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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.
Andrew D Pucker, OD, MS principal investigator
Ohio State University
Jeffrey J Walline, OD, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing senofilcon A in people with Contact Lens Comfort, 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 3 inclusion and 8 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 Sep 2022. 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 22 Aug 2022). 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?
Between-Group Difference in Eye Comfort as Measured by the Ocular Surface Disease Index (OSDI) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02148263, which also lists 9 linked publications.
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 Sep 2022.