Clinical Investigation of Visual Acuity in Contact Lens Wearers After Instillation of a Lipid- Based Lubricating Eye Drop
Overview
- Phase
- Phase 1
- Intervention
- Blink® Tears eye drops
- Conditions
- Visual Acuity
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Visual Acuity (logMAR) at 10 Minutes Post Instillation
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a single visit, randomized, double masked, bilateral, non-dispensing, 2×2 crossover study to assess visual acuity.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- •The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •Between 18 and 69 (inclusive) years of age at the time of screening.
- •Subjects must be habitual spherical soft contact lens wearers.
- •Subjects must achieve visual acuity of 20/30 or better in each eye with their habitual contact lenses.
Exclusion Criteria
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •The subject must not:
- •Currently pregnant or breast-feeding.
- •Any ocular or systemic allergies or disease which may interfere with the clinical trial (at the discretion of the investigator).
- •Any systemic disease, autoimmune disease, or use of medication which may interfere with the clinical trial (at the discretion of the investigator).
- •Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
- •History of any ocular or corneal surgery (e.g. RK, PRK, LASIK)
- •Participation in any pharmaceutical or medical device related clinical trial within 14 days prior to study enrollment.
- •History of binocular vision abnormality or strabismus.
- •Habitual wearers of rigid gas permeable lens within the past 3 months
Arms & Interventions
Control/Test
Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to receive the CONTROL lubricating eye drops, with a washout period of 90 minutes between instillations. After the wash-out period, the TEST lubricating eye drops will be instilled.
Intervention: Blink® Tears eye drops
Test/Control
Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to receive the TEST lubricating eye drops, with a washout period of 90 minutes between instillations. After the wash-out period, the CONTROL lubricating eye drops will be instilled.
Intervention: Blink® Tears eye drops
Test/Control
Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to receive the TEST lubricating eye drops, with a washout period of 90 minutes between instillations. After the wash-out period, the CONTROL lubricating eye drops will be instilled.
Intervention: Investigational lipid eye drops
Control/Test
Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to receive the CONTROL lubricating eye drops, with a washout period of 90 minutes between instillations. After the wash-out period, the TEST lubricating eye drops will be instilled.
Intervention: Investigational lipid eye drops
Outcomes
Primary Outcomes
Visual Acuity (logMAR) at 10 Minutes Post Instillation
Time Frame: 10 minutes post instillation
High contrast bright illumination monocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicate better vision. The average logMAR visual acuity for each treatment was reported.
Visual Acuity (logMAR) at 3 Minutes Post Instillation
Time Frame: 3 minutes post instillation
High contrast bright illumination monocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicate better vision. The average logMAR visual acuity for each treatment was reported.