MyopiaNCT03098745
Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses
A study testing Omafilcon A, Somofilcon A and Omafilcon A - Proclear (PC) in people with Myopia, run by CooperVision, Inc. at 1 site in Mexico.
Trial summary
The aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision performance of three monthly replacement sphere lenses. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Omafilcon A, Somofilcon A and Omafilcon A - Proclear (PC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 1 Feb 2017to 11 Apr 2017
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A person is eligible for inclusion in the study if he/she:
- Is between 18 and 40 years of age (inclusive).
- Has had a self-reported visual exam in the last two years.
- Is an adapted soft CL (Contact Lens) wearer who is not wearing any of the study lenses.
- Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
- Has a spectacle cylinder up to 0.75D (Diopter) in each eye.
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- Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
- Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
- Has clear corneas and no active ocular disease.
- Has read, understood and signed the information consent letter.
- Patient contact lens refraction should fit within the available parameters of the study lenses.
- Is willing to comply with the wear schedule.
- Is willing to comply with the visit schedule.
Who cannot join
- A person will be excluded from the study if he/she:
- Has never worn contact lenses before.
- Currently wears rigid gas permeable contact lenses.
- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- Has a CL prescription outside the range of - 1.00 to - 6.00D
- Has a spectacle cylinder ≥1.00D of cylinder in either eye.
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- Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
- Presence of clinically significant (grade 2-4) anterior segment abnormalities.
- Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
- Slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Pterygium, pinguecula, or corneal scars within the visual axis
- Neovascularization > 0.75 mm in from of the limbus
- Giant papillary conjunctivitis (GCP) worse than grade 1
- Anterior uveitis or iritis (past or present)
- Seborrheic eczema, Seborrheic conjunctivitis
- History of corneal ulcers or fungal infections
- Poor personal hygiene
- Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
- Has aphakia, keratoconus or a highly irregular cornea.
- Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses.
The aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision performance of three monthly replacement sphere lenses.
Read the detailed description
This is a 40-subject, double masked, randomized, bilateral, non-dispensing fitting trial comparing hydrogel and silicone hydrogel lens materials. It is anticipated that this study will involve 2 visits for each lens pair, as follows: Visits: V1 (lens dispensing), V2 (1 hour post lens settling). Each subject will be randomized to wear each pair bilaterally in a series of three short fitting comparisons.
- Conditions
- Myopia
- Being tested
- Omafilcon A, Somofilcon A, Omafilcon A - Proclear (PC)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omafilcon ADevice
contact lens
Somofilcon ADevice
contact lens
Omafilcon A - Proclear (PC)Device
contact lens
| Study group | Role | What they receive |
|---|---|---|
| Omafilcon A | Active comparator | Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study. Receives: Device: Omafilcon A |
| Somofilcon A | Active comparator | Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study. Receives: Device: Somofilcon A |
| Omafilcon A - Proclear (PC) | Active comparator | Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study. Receives: Device: Omafilcon A - Proclear (PC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
High contrast distance visual acuity assessed for each lens pair using LogMAR chart at time of lens insertion, then assessing again 1 hour later with spectacles after lenses are removed.
Measured: Baseline (lens insertion), 1 hour
Comfort
Subjective comfort (Scale 0-100: 0=very uncomfortable, 100= very comfortable)
Measured: Insertion, 1hr
Lens Centration
Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)
Measured: Insertion
Lens Centration
Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)
Measured: 1 Hour
Post-blink Lens Movement
Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)
Measured: Insertion
Post-blink Lens Movement
Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)
Measured: 1 Hour
Lens Fit Acceptance
Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)
Measured: Insertion
Lens Fit Acceptance
Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)
Measured: 1 Hour
Lens Fit Preference
Investigator lens fit preference (Scale: omafilcon A, somofilcon A, omafilcon A - Proclear (PC))
Measured: 1 Hour
Limbal Redness
Redness of limbal area (Scale: 0-4, 0 = none, 4=severe)
Measured: 1 Hour
Bulbar Redness
Redness of bulbar conjunctiva (Scale: 0-4, 0 = none, 4=severe)
Measured: 1 Hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Feb 2017
- Primary completion1 Mar 2017
- Study completion11 Apr 2017
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruben Velázquez Guerrero, MSc., FIACLE, Principal investigator, National Autonomous University, School of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098745
- Sponsor's protocol ID
- EX-MKTG-79
- Status last verified
- Apr 2019
- First submitted
- 28 Mar 2017
- Last updated
- 9 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses.
- ClinicalTrials.gov ID
- NCT03098745
- Acronym / sponsor ID
- EX-MKTG-79
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 11 Apr 2017 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Posted 9 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision performance of three monthly replacement sphere lenses.
Detailed description
This is a 40-subject, double masked, randomized, bilateral, non-dispensing fitting trial comparing hydrogel and silicone hydrogel lens materials. It is anticipated that this study will involve 2 visits for each lens pair, as follows: Visits: V1 (lens dispensing), V2 (1 hour post lens settling). Each subject will be randomized to wear each pair bilaterally in a series of three short fitting comparisons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Omafilcon A | Active comparator | Device: Omafilcon AParticipants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study. |
| Somofilcon A | Active comparator | Device: Somofilcon AParticipants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study. |
| Omafilcon A - Proclear (PC) | Active comparator | Device: Omafilcon A - Proclear (PC)Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- A person is eligible for inclusion in the study if he/she:
Key exclusion criteria (23 listed)
- A person will be excluded from the study if he/she:
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 |
|---|---|---|
| Omafilcon Acontact lens | Device | Omafilcon A |
| Somofilcon Acontact lens | Device | Somofilcon A |
| Omafilcon A - Proclear (PC)contact lens | Device | Omafilcon A - Proclear (PC) |
Primary outcome
Visual Acuity
Time frame: Baseline (lens insertion), 1 hour
High contrast distance visual acuity assessed for each lens pair using LogMAR chart at time of lens insertion, then assessing again 1 hour later with spectacles after lenses are removed.
Comfort
Time frame: Insertion, 1hr
Subjective comfort (Scale 0-100: 0=very uncomfortable, 100= very comfortable)
Lens Centration
Time frame: Insertion
Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)
Lens Centration
Time frame: 1 Hour
Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)
Post-blink Lens Movement
Time frame: Insertion
Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)
Post-blink Lens Movement
Time frame: 1 Hour
Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)
Lens Fit Acceptance
Time frame: Insertion
Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)
Lens Fit Acceptance
Time frame: 1 Hour
Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)
Lens Fit Preference
Time frame: 1 Hour
Investigator lens fit preference (Scale: omafilcon A, somofilcon A, omafilcon A - Proclear (PC))
Limbal Redness
Time frame: 1 Hour
Redness of limbal area (Scale: 0-4, 0 = none, 4=severe)
Bulbar Redness
Time frame: 1 Hour
Redness of bulbar conjunctiva (Scale: 0-4, 0 = none, 4=severe)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ruben Velázquez Guerrero, MSc., FIACLE principal investigator
National Autonomous University, School of Optometry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omafilcon A, Somofilcon A and Omafilcon A - Proclear (PC) in people with Myopia, run by CooperVision, Inc. at 1 site in Mexico.
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 13 inclusion and 23 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 9 Apr 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 Mexico. 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 9 Apr 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?
Visual Acuity (time frame: Baseline (lens insertion), 1 hour). The study lists 11 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 9 Apr 2019.