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

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.

• Lens 1 (ocufilcon D) (Device): 15 minutes of daily wear
• Lens 2 (somofilcon A) (Device): 15 minutes of daily wear

Primary outcomes

• Subjective Overall Score [At the end of 15 minutes of daily wear]: 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).

Secondary outcomes

• Subjective Vision [At the end of 15 minutes of daily wear]: 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).
• Subjective Comfort [At the end of 15 minutes of daily wear]: 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).

Sex: All, ages: 18 Years to any

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 Informed Consent.
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:

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 immunosuppressive 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.

Participant flow

Outcome results

• Subjective Overall Score (Primary), Mean, Units on Scale: Lens 1 (Ocufilcon D) 80.8 +/- 16.4; Lens 2 (Somofilcon A) 82.9 +/- 15.9
• Subjective Vision (Secondary), Mean, units on a scale: Lens 1 (Ocufilcon D) 80.9 +/- 17.6; Lens 2 (Somofilcon A) 83.1 +/- 15.9
• Subjective Comfort (Secondary), Mean, units on a scale: Lens 1 (Ocufilcon D) 87.6 +/- 15.5; Lens 2 (Somofilcon A) 84.5 +/- 19.0

Adverse events

Time frame: Through study completion (single visit, approximately 30 minutes)

• Study Protocol and Statistical Analysis Plan (PDF, 2024-09-13)

• Carole Maldonado-Codina, PhD, FBCLA, Principal investigator, Eurolens Research