MyopiaNCT01461811
Prospective Study of an Investigational Toric Soft Contact Lens
A study testing Nelfilcon A toric contact lenses (with comfort additives) and Nelfilcon A toric contact lenses in people with Myopia and Astigmatism, run by CIBA VISION.
Trial summary
The purpose of this study was to demonstrate substantial equivalence of an investigational toric soft contact lens to the commercially available Focus® DAILIES® Toric soft contact lens when worn in a daily wear, daily disposable mode for three months. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myopia, Astigmatism, Refractive Error
- What is being tested?
- Nelfilcon A toric contact lenses (with comfort additives) and Nelfilcon A toric contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Apr 2012
- Phase
- Interventional
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and participant must sign Assent document.
- Normal eyes not using any ocular medications that would contraindicate lens wear.
- Willing and able to wear toric contact lenses in both eyes within the available range of powers for this trial.
- Spectacle cylinder prescription between 0.50 and 2.00 diopters.
- Best spectacle corrected visual acuity 20/25 (Snellen) or better in each eye at distance.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Anterior segment infection, inflammation, or abnormality.
- Any active anterior segment or systemic disease that would contraindicate contact lens wear.
- Use of systemic medications that would contraindicate lens wear.
- Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study.
- History of herpetic keratitis.
- History of refractive surgery or irregular cornea.
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- History of pathologically dry eye.
- Corneal vascularization greater than 1 mm of penetration.
- Eye injury within twelve weeks immediately prior to enrollment in this trial.
- Participation in a contact lens or contact lens care product clinical trial within the previous 30 days, or concurrent participation in any clinical trial.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: ARES Registration Trial
The purpose of this study was to demonstrate substantial equivalence of an investigational toric soft contact lens to the commercially available Focus® DAILIES® Toric soft contact lens when worn in a daily wear, daily disposable mode for three months.
Read the detailed description
Eligible participants were randomized 2:1 to wear either DAILIES® AquaComfort Plus® Toric or Focus® DAILIES® Toric.
- Conditions
- Myopia, Astigmatism, Refractive Error
- Being tested
- Nelfilcon A toric contact lenses (with comfort additives), Nelfilcon A toric contact lenses
- Keywords
- toric, contact lenses, daily disposable contact lenses, astigmatism, soft contact lenses, contact lens comfort
- Medical subject headings
- Myopia, Astigmatism, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nelfilcon A toric contact lenses (with comfort additives)Device
Nelfilcon A toric contact lensesDevice
Also called Focus® DAILIES® Toric
| Study group | Role | What they receive |
|---|---|---|
| DAILIES® AquaComfort Plus® Toric | Experimental | Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months Receives: Device: Nelfilcon A toric contact lenses (with comfort additives) |
| Focus® DAILIES® Toric | Active comparator | Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months Receives: Device: Nelfilcon A toric contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)
Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.
Measured: Up to Month 3
Secondary outcomes (11)
Subjective Rating of Insertion Comfort
Insertion comfort (30 seconds to 1 minute), as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
Measured: Up to Month 3
Subjective Rating of End of Day Comfort
End of day comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
Measured: Up to Month 3
Subjective Rating of Overall Comfort
Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
Measured: Up to Month 3
Subjective Rating of End of Day Dryness
End of day dryness, as rated by the participant on a 10-point scale, with 1 being dry and 10 being not dry. The participant rated both eyes together by providing one single rating.
Measured: Up to Month 3
Subjective Rating of Overall Vision
Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
Measured: Up to Month 3
Subjective Rating of Overall Handling
Overall handling, as rated by the participant on a 10-point scale, with 1 being difficult and 10 being easy. The participant rated both eyes together by providing one single rating.
Measured: Up to Month 3
Lens Centration (Centered, Slight Decentration)
Lens centration, as assessed by the investigator for each eye individually. Lens centration was graded on a 5-point scale: 0=centered, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.
Measured: Up to Month 3
Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)
Lens fit, as assessed by the investigator for each eye individually. Lens fit was graded on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. The combined percentage of lenses assessed as "optimal," "acceptably loose," or "acceptably tight" is reported. Lenses from both eyes contributed to the percentage.
Measured: Up to Month 3
Front Surface Wettability (None, Very Slight)
Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Front surface wettability was graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.
Measured: Up to Month 3
Front Surface Deposits (None, Very Slight)
Front surface deposits on the contact lens, as assessed by the investigator for each eye individually. Front surface deposits were graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.
Measured: Up to Month 3
Back Surface Debris/Deposits (None, Very Slight)
Back surface debris/deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface debris/deposits were graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.
Measured: Up to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2012
- Study completionApr 2012
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- CIBA VISION
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Fahmy, OD, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461811
- Sponsor's protocol ID
- C-11-035 (P-415-C-003)
- Status last verified
- Aug 2013
- First submitted
- 26 Oct 2011
- Last updated
- 17 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No