Clinical Evaluation of Approved and Investigational Contact Lenses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 150
- Locations
- 8
- Primary Endpoint
- Acceptable Lens Fitting
Study Overview
Brief Summary
This study is a multi-site, 5-visit dispensing, bilateral double-arm parallel group design, double-masked clinical trial using an investigational contact lens and a marketed contact lens. The objective is to evaluate comfort of the contact lenses when worn on a daily wear modality.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •The subject must be between 18 to 40 years of age at the time of consent.
- •The subject's vertexed spherical equivalent distance refraction must be in the range of +8.00 to -12.00 in each eye.
- •Subject wears habitual contact lenses a minimum of 4 days per week, eight hours per day.
- •The subject must have best corrected visual acuity of 20/30 or better in each eye.
- •The subject must be a habitual frequent replacement daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.
- •The subject must be able to wear contact lenses for a minimum of 8 hours each day during the study.
- •The subject must have normal eyes (i.e., no ocular medications or infections of any type).
Exclusion Criteria
- •Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- •Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- •Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
- •Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution.
- •Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
- •Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
- •Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
- •Any ocular infection.
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
Outcomes
Primary Outcomes
Acceptable Lens Fitting
Time Frame: Up to 4 Week Follow-up
Lens fit was assessed and recorded for each subject and eye at post lens fitting, 1-, 2-, 3- and 4- week follow-up evaluations. Lens fit was a binary response acceptable and unacceptable lens fit. The proportion of eyes with acceptable lens fitting at post lens fit and across all four follow-ups was combined and reported.
Overall Comfort
Time Frame: Up to 4 Week Follow-up
Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. CLUE Comfort was assessed at 1-, 2-, 3 and 4- week Follow-up evaluations. The average CLUE comfort score for each lens was reported for each visit.
Secondary Outcomes
No secondary outcomes reported