MyopiaNCT01473160
Daily Disposable Contact Lens Tear Film Study
A study testing delefilcon A contact lens and narafilcon A contact lens in people with Myopia, run by CIBA VISION at 1 site in United Kingdom.
Trial summary
The purpose of this study was to evaluate the pre-lens tear film stability of a new CE-marked daily disposable contact lens as compared to a commercially available daily disposable contact lens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- delefilcon A contact lens and narafilcon A contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2011to Dec 2011
- 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
- Be of legal age of consent and sign Informed Consent document.
- Willing and able to wear spherical contact lenses for 16 hours.
- Willing and able to wear spherical contact lenses within the available range of powers.
- Best corrected spectacle visual acuity equal or better than 20/25 or 6/7.5.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Anterior segment infection, inflammation, or abnormality.
- Any use of systemic medications for which contact lens wear could be contraindicated.
- History of refractive surgery or irregular cornea.
- Currently enrolled in any clinical trial.
- Eye injury within twelve weeks prior to enrollment.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DAILIES TOTAL1 Pre-Lens Tear Film Performance - Pilot Trial
The purpose of this study was to evaluate the pre-lens tear film stability of a new CE-marked daily disposable contact lens as compared to a commercially available daily disposable contact lens.
- Conditions
- Myopia
- Being tested
- delefilcon A contact lens, narafilcon A contact lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delefilcon A contact lensDevice
Also called DAILIES TOTAL1
CE-marked, silicone hydrogel, single vision, soft contact lens for daily disposable wear
narafilcon A contact lensDevice
Also called 1-DAY ACUVUE TruEye
Commercially marketed, silicone hydrogel, single vision, soft contact lens for daily disposable wear.
| Study group | Role | What they receive |
|---|---|---|
| delefilcon A | Experimental | Delefilcon A randomly assigned to one eye, with narafilcon A assigned to the fellow eye for contralateral wear. Both products will be worn for one day for 16 hours (+/- 1 hour). Receives: Device: delefilcon A contact lens |
| narafilcon A | Active comparator | Narafilcon A randomly assigned to one eye, with delefilcon A assigned to the fellow eye for contralateral wear. Both products will be worn for one day for 16 hours (+/- 1 hour). Receives: Device: narafilcon A contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Corrected Visual Acuity of 0.0 or Better
Corrected visual acuity was measured with a digitized logMAR (logarithm of the minimum angle of resolution) chart. A logMAR acuity of 0.0 is considered normal distance eyesight.
Measured: Up to 16 hours after lens insertion
Pre-Lens Noninvasive Tear Break-Up Time
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a lengthening in the tear film break up time.
Measured: Up to 16 hours after lens insertion
Average Tear Meniscus Height
The tear meniscus height, i.e., the distance between the line of reflection along the top of the tear prism to the edge of the eyelid, was measured by the investigator using a digital slit lamp.
Measured: Up to 16 hours after lens insertion
Average Ocular Surface Temperature
Ocular surface temperature (OST) was recorded by the investigator using a dynamic, non-contact, infrared thermography camera. The average OST (encompassing the wear of a contact lens) was taken at the center of the cornea, at the temporal upper limbal area, and over the central 5 mm2 of the cornea, 2 seconds post-blink.
Measured: Up to 16 hours after lens insertion
Secondary outcomes (3)
Subjective Comfort
Overall comfort was assessed by the participant and recorded on a scale from 0 (poor) to 10 (excellent) in response to the question, "How comfortable is the lens feeling at present?"
Measured: Up to 16 hours after lens insertion
Subjective Vision
Overall vision was assessed by the participant on scale from 0 (poor) to 10 (excellent) in response to the question, "What is the quality of your vision with the lens at present?"
Measured: Up to 16 hours after lens insertion
Number of Participants With Adequate Lens Fit
Lens fit was assessed by the investigator with a biomicroscope (slit lamp).
Measured: Up to 16 hours after lens insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2011
- Study completionDec 2011
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 MyopiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- CIBA VISION
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aston University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473160
- Sponsor's protocol ID
- P-347-C-014v2
- Status last verified
- Jan 2013
- First submitted
- 14 Nov 2011
- Last updated
- 17 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAILIES TOTAL1 Pre-Lens Tear Film Performance - Pilot Trial
- ClinicalTrials.gov ID
- NCT01473160
- Acronym / sponsor ID
- P-347-C-014v2
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- CIBA VISIONIndustry (pharma, biotech, devices)
- Collaborators
- Aston University
- Study start
- Nov 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Posted 16 Jan 2013
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 study was to evaluate the pre-lens tear film stability of a new CE-marked daily disposable contact lens as compared to a commercially available daily disposable contact lens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| delefilcon A | Experimental | Device: delefilcon A contact lensDelefilcon A randomly assigned to one eye, with narafilcon A assigned to the fellow eye for contralateral wear. Both products will be worn for one day for 16 hours (+/- 1 hour). |
| narafilcon A | Active comparator | Device: narafilcon A contact lensNarafilcon A randomly assigned to one eye, with delefilcon A assigned to the fellow eye for contralateral wear. Both products will be worn for one day for 16 hours (+/- 1 hour). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be of legal age of consent and sign Informed Consent document.
- Willing and able to wear spherical contact lenses for 16 hours.
- Willing and able to wear spherical contact lenses within the available range of powers.
- Best corrected spectacle visual acuity equal or better than 20/25 or 6/7.5.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (6 listed)
- Anterior segment infection, inflammation, or abnormality.
- Any use of systemic medications for which contact lens wear could be contraindicated.
- History of refractive surgery or irregular cornea.
- Currently enrolled in any clinical trial.
- Eye injury within twelve weeks prior to enrollment.
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 |
|---|---|---|
| delefilcon A contact lensAlso: DAILIES TOTAL1CE-marked, silicone hydrogel, single vision, soft contact lens for daily disposable wear | Device | delefilcon A |
| narafilcon A contact lensAlso: 1-DAY ACUVUE TruEyeCommercially marketed, silicone hydrogel, single vision, soft contact lens for daily disposable wear. | Device | narafilcon A |
Primary outcome
Number of Participants With Corrected Visual Acuity of 0.0 or Better
Time frame: Up to 16 hours after lens insertion
Corrected visual acuity was measured with a digitized logMAR (logarithm of the minimum angle of resolution) chart. A logMAR acuity of 0.0 is considered normal distance eyesight.
Pre-Lens Noninvasive Tear Break-Up Time
Time frame: Up to 16 hours after lens insertion
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a lengthening in the tear film break up time.
Average Tear Meniscus Height
Time frame: Up to 16 hours after lens insertion
The tear meniscus height, i.e., the distance between the line of reflection along the top of the tear prism to the edge of the eyelid, was measured by the investigator using a digital slit lamp.
Average Ocular Surface Temperature
Time frame: Up to 16 hours after lens insertion
Ocular surface temperature (OST) was recorded by the investigator using a dynamic, non-contact, infrared thermography camera. The average OST (encompassing the wear of a contact lens) was taken at the center of the cornea, at the temporal upper limbal area, and over the central 5 mm2 of the cornea, 2 seconds post-blink.
3 secondary outcomes
Subjective Comfort
Time frame: Up to 16 hours after lens insertion
Subjective Vision
Time frame: Up to 16 hours after lens insertion
Number of Participants With Adequate Lens Fit
Time frame: Up to 16 hours after lens insertion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
- 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 delefilcon A contact lens and narafilcon A contact lens in people with Myopia, run by CIBA VISION at 1 site in United Kingdom.
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 6 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 17 Apr 2013. 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 Kingdom. 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 16 Jan 2013). 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?
Number of Participants With Corrected Visual Acuity of 0.0 or Better (time frame: Up to 16 hours after lens insertion). The study lists 4 primary outcomes in all. 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 17 Apr 2013.