Clinical trial NCT03920280: Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens
Official title: Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Keywords: Contact Lens
Daily Wear
Vision Correction
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2019-04-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to demonstrate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality.

Detailed description: Subjects will be randomized to wear either the investigational contact lenses or the commercially available contact lenses in both eyes. Subjects will be expected to attend 6 scheduled study visits. Individual participation in the study will be approximately 3 months.

Eligibility criteria: Key Inclusion Criteria:

* Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
* Manifest cylinder ≤ 0.75 diopter (D) in each eye.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
* Monovision contact lens wearers.
* Habitually wearing Biofinity® lenses.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
timeFrame: Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up/Exit (at least 4 hours after lens insertion at each follow-up assessment visit)
measure: Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes
timeFrame: Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Alcon Investigator 6565
state: Florida
city: Orlando
country: United States
facility: Alcon Investigator 6355
state: Florida
city: Pensacola
country: United States
facility: Alcon Investigator 6291
state: Florida
city: Bloomington
country: United States
facility: Alcon Investigator 3950
state: Illinois
city: Pittsburg
country: United States
facility: Alcon Investigator 6567
state: Kansas
city: Powell
country: United States
facility: Alcon Investigator 6313
state: Ohio
city: Warwick
country: United States
facility: Alcon Investigator 6401
state: Rhode Island
city: Memphis
country: United States
facility: Alcon Investigator 6353
state: Tennessee
Study officials:
affiliation: Alcon Research, LLC
name: CDMA Project Lead, Vision Care
role: STUDY_DIRECTOR
References: