ClinicalTrials.gg
CompletedNCT06758076Updated Jul 8, 2026Results posted

A Clinical Comparison of Two Soft Contact Lenses (C24-755)

An interventional study of Lens 1 (ocufilcon D) and Lens 2 (somofilcon A) in Hyperopia and Myopia, sponsored by CooperVision, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by CooperVision, Inc. (part of CooperCompanies) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study summary

The aim of this study is to compare the short-term clinical performance of two soft contact lenses.

Read the detailed description

The aim of this study is to evaluate the short-term clinical performance of two soft contact lenses when compared to each other after 15 minutes of daily wear each.

02

Conditions studied

  • Hyperopia
  • Myopia

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03

In context

Hyperopia

156 studies on the registry are indexed under Hyperopia; 20 are open to participants now.

This study's enrollment of 52 is below the median of 60 across 125 interventional studies indexed under Hyperopia.

Browse Hyperopia studies →

Lead sponsor

CooperVision, Inc. is the lead sponsor of 39 studies on the registry; none are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 31 (94%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. They are of legal age (18) and capacity to volunteer.
  2. They understand their rights as a research subject and are willing and able to sign a Statement of .
  3. They are willing and able to follow the protocol.
  4. They currently wear soft contact lenses, or have done so within the past two years.
  5. They are expected to be able to be fitted with the study lenses within the power range available.

Exclusion criteria

Exclusion Criteria:

  1. They have an ocular disorder which would normally contra-indicate contact lens wear.
  2. They have a systemic disorder which would normally contra-indicate contact lens wear.
  3. They are using any topical medication such as eye drops or ointment.
  4. They are aphakic.
  5. They have had corneal refractive surgery.
  6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  7. They are pregnant or breastfeeding.
  8. They have an eye or health condition including an or infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
  9. They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Lens 1 (ocufilcon D)

    All participants will wear lens 1 for 15 minutes (Period 1).

    Device: Lens 1 (ocufilcon D)

  • Experimental
    Lens 2 (somofilcon A)

    All participants will wear lens 2 for 15 minutes (Period 2).

    Device: Lens 2 (somofilcon A)

Interventions

  • DeviceLens 1 (ocufilcon D)

    15 minutes of daily wear

  • DeviceLens 2 (somofilcon A)

    15 minutes of daily wear

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What researchers measure

Primary outcomes

  1. Subjective Overall Score

    The primary outcome measure for this study is the subjective overall score on a scale of 0-100 (0= Extremely poor, unmanageable, cannot use lenses, 100= Excellent, highly impressed with these lenses overall).

    Time frame: At the end of 15 minutes of daily wear

Secondary outcomes

  1. Subjective Vision

    The secondary outcome measure for this study is the subjective vision on a scale of 0-100 (0= Extremely poor, intolerable, lenses cannot be worn, 100= Excellent, unaware of any visual loss).

    Time frame: At the end of 15 minutes of daily wear

  2. Subjective Comfort

    The secondary outcome measure for this study is the subjective comfort on a scale of 0-100 (0= Extremely uncomfortable, causes pain, cannot be tolerated, 100= Excellent, cannot be felt).

    Time frame: At the end of 15 minutes of daily wear

07

Results

Posted Jul 8, 2026

Participant flow

Period 1: Lens 1 (ocufilcon D) 15minutes
Participant flow — Period 1: Lens 1 (ocufilcon D) 15minutes
MilestoneLens 1 (Ocufilcon D) Then Lens 2 (Somofilcon A)
Started52
Completed50
Not completed2
Withdrew: Severe environmental allergies1
Withdrew: Eligibility criteria1
Period 2: Lens 2 (somoflcon A) 15minutes
Participant flow — Period 2: Lens 2 (somoflcon A) 15minutes
MilestoneLens 1 (Ocufilcon D) Then Lens 2 (Somofilcon A)
Started50
Completed50
Not completed0

Outcome measures

PrimarySubjective Overall Score

The primary outcome measure for this study is the subjective overall score on a scale of 0-100 (0= Extremely poor, unmanageable, cannot use lenses, 100= Excellent, highly impressed with these lenses overall).

Time frame:
At the end of 15 minutes of daily wear
Reported as:
Mean · Units on Scale
Subjective Overall Score
Units on ScaleLens 1 (Ocufilcon D)Lens 2 (Somofilcon A)
Subjective Overall Score80.8 ± 16.482.9 ± 15.9
SecondarySubjective Vision

The secondary outcome measure for this study is the subjective vision on a scale of 0-100 (0= Extremely poor, intolerable, lenses cannot be worn, 100= Excellent, unaware of any visual loss).

Time frame:
At the end of 15 minutes of daily wear
Reported as:
Mean · units on a scale
Subjective Vision
units on a scaleLens 1 (Ocufilcon D)Lens 2 (Somofilcon A)
Subjective Vision80.9 ± 17.683.1 ± 15.9
SecondarySubjective Comfort

The secondary outcome measure for this study is the subjective comfort on a scale of 0-100 (0= Extremely uncomfortable, causes pain, cannot be tolerated, 100= Excellent, cannot be felt).

Time frame:
At the end of 15 minutes of daily wear
Reported as:
Mean · units on a scale
Subjective Comfort
units on a scaleLens 1 (Ocufilcon D)Lens 2 (Somofilcon A)
Subjective Comfort87.6 ± 15.584.5 ± 19.0

Adverse events

Collected over Through study completion (single visit, approximately 30 minutes). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lens 1 (Ocufilcon D)0/50 (0%)0/50 (0%)0/50 (0%)
Lens 2 (Somofilcon A)0/50 (0%)0/50 (0%)0/50 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Years)All Study Participants
Mean41.3 ± 14.9
Sex: Female, Male
Sex: Female, Male(Participants)All Study Participants
Female34
Male16
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)All Study Participants
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Study locations

1 site
  • Eurolens Research
    Manchester, United Kingdom
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06758076
Lead sponsor
CooperVision, Inc.
Responsible party
Sponsor
First posted
Jan 3, 2025
Start date
Nov 18, 2024
Primary completion
Jan 31, 2025
Completion
Jan 31, 2025
Results posted
Jul 8, 2026
Last update
Jul 8, 2026

Study contacts

Carole Maldonado-Codina, PhD, FBCLA
principal investigator · Eurolens Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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