Evaluation of Lens Fit, Lens Parameters, and Circumlimbal Conjunctival Staining (CSS) in Normal Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Mean Circumlimbal Conjunctival Staining Score
Study Overview
Brief Summary
The purpose of this study was to investigate contact lens fit, lens parameters, and conjunctival staining in a sample of subjects with various contact lens/solution combinations.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Successfully wearing hydrogel and/or silicone hydrogel contact lenses;
- •Read, sign, and date informed consent/HIPAA document;
- •Vision correctable to 20/30 (Snellen) or better in each eye at distance with habitual spectacles;
- •Willing and able to discontinue contact lens wear when requested during the study;
- •Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- •Evidence or history of ocular disease or pathology;
- •One functional eye or a monofit lens;
- •Use of concomitant topical ocular prescription or over-the-counter ocular medications;
- •History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear;
- •Other protocol-defined exclusion criteria may apply.
Arms & Interventions
ReNu MultiPlus
ReNu MultiPlus used as specified in the protocol for contact lens care. In this crossover study, ReNu MultiPlus was dispensed in randomized order with Complete Easy Rub and Clear Care. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period.
Intervention: ReNu MultiPlus (Device)
ReNu MultiPlus
ReNu MultiPlus used as specified in the protocol for contact lens care. In this crossover study, ReNu MultiPlus was dispensed in randomized order with Complete Easy Rub and Clear Care. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period.
Intervention: Contact lenses (Device)
Complete Easy Rub
Complete Easy Rub used as specified in the protocol for contact lens care. In this crossover study, Complete Easy Rub was dispensed in randomized order with ReNu MultiPlus and Clear Care. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period.
Intervention: Complete Easy Rub (Device)
Complete Easy Rub
Complete Easy Rub used as specified in the protocol for contact lens care. In this crossover study, Complete Easy Rub was dispensed in randomized order with ReNu MultiPlus and Clear Care. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period.
Intervention: Contact lenses (Device)
Clear Care
Clear Care used as specified in the protocol for contact lens care. In this crossover study, Clear Care was dispensed in randomized order with Complete Easy Rub and ReNu MultiPlus. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period.
Intervention: Clear Care (Device)
Clear Care
Clear Care used as specified in the protocol for contact lens care. In this crossover study, Clear Care was dispensed in randomized order with Complete Easy Rub and ReNu MultiPlus. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period.
Intervention: Contact lenses (Device)
Outcomes
Primary Outcomes
Mean Circumlimbal Conjunctival Staining Score
Time Frame: 1 week
Circumlimbal conjunctival staining was expressed as the sum of the individual scores observed across all of the evaluated regions of the eye. The bulbar conjunctiva was assessed by the investigator utilizing a slit-lamp and lissamine green ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 4-point clinical grading scale (grade 0-3), where Grade 0 = No staining present; Grade 1 = Slight staining present; Grade 2 = Moderate staining present; and Grade 3 = Dense staining present. The scores for the four regions were summed, with a sum score range of 0-12. A lower score represents a more desirable outcome.
Secondary Outcomes
- Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week(Dispense (Day 0), 1 week)
- Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week(Dispense (Day 0), 1 week)