Quantifying Ocular Surface Aberrations After Tear Film Interventions (GAMBIA)

University of Waterloo

Status and phase: Enrolling; Phase 4

Conditions: Tear Film Characteristics

Treatments: Device: Somofilcon A; Device: Senofilcon A; Drug: Systane Complete Preservative-Free

Study type: Interventional

Funder types: Other

Identifiers

NCT06966349

47100

Details and patient eligibility

About

The CA-800 Corneal Analyzer (Visia Imaging S.R.L., Italy) is a device that can measure small imperfections in the tear film when the eyes are open. The goal of this study is to see if the device can detect changes in the tear film after instillation of an eye drop or when contact lenses are worn.

Enrollment: 12 estimated patients

Sex: All

Ages: 17+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Are at least 17 years of age and have full legal capacity to volunteer.
2. Have signed the information consent letter.
3. Are willing and able to follow instructions and maintain the appointment schedule.
4. Habitually wear spherical soft contact lenses (no multifocal lens, no toric lens wear or extended (overnight) wear).
5. Have a vertex-corrected refractive astigmatism of no more than 0.75D in each eye.
6. Achieve a best corrected visual acuity of 0.00 logMAR or better in each eye.
7. Agree to wear the study contact lenses for at least 6 hours.
8. Have clear corneas (e.g. no central scars).
9. Have no active ocular disease or inflammation.

Exclusion criteria

1. Are participating in another concurrent clinical research study.
2. Have worn any rigid contact lenses in the past 30 days.
3. Have been diagnosed with irregular cornea (e.g., keratoconus, etc.).
4. Have any known active ocular condition, disease, and/or infection.*
5. Have a systemic or ocular condition that, in the opinion of the investigator, may affect a study outcome variable.
6. Have a known sensitivity to the diagnostic sodium fluorescein to be used in the study.
7. Have undergone refractive error surgery.
8. Are a member of the study team for this study, i.e. are listed on the delegation log for this study.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 2 patient groups

Experimental: Systane Complete / Senofilcon A/ Somofilcon A

Experimental group

Description:

On the first day of the study, one drop of Systane Complete will be instilled in each eye. On the second day of the study, senofilcon A will be worn in both eyes. On the third day of the study, somofilcon A will be worn in both eyes.

Treatment:

Device: Senofilcon A

Drug: Systane Complete Preservative-Free

Device: Somofilcon A

Experimental: Systane Complete/ Somofilcon A/ Senofilcon A

Experimental group

Description:

On the first day of the study, one drop of Systane Complete will be instilled in each eye. On the second day of the study, somofilcon A will be worn in both eyes. On the third day of the study, senofilcon A will be worn in both eyes.

Treatment:

Device: Senofilcon A

Drug: Systane Complete Preservative-Free

Device: Somofilcon A