Clinical trial NCT01966770: Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses
Official title: Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2013-10-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this fitting study is to evaluate the clinical performance of different hydrogel and silicone hydrogel contact lenses.

Detailed description: This is a 20-subject, double masked, randomized, contra lateral, 2-day non-dispensing fitting trial.

Eligibility criteria: Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

* Is between 18 and 40 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is an adapted soft contact lens wearer
* Has a cl spherical prescription between -1.00 and -6.00 (inclusive)
* Has a spectacle cylinder up to 0.75D (diopter) in each eye
* Is correctable to a visual acuity of 20/25 or better in both eyes
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter
* Is willing to comply with the wear schedule
* Is willing to comply with the visit schedule

Exclusion Criteria:

A person will be excluded from the study if he/she:

* Has never worn contact lenses before
* Currently wears rigid gas permeable contact lenses
* Has a history of not achieving comfortable contact lens wear (5 days per week; \> 8 hours/day)
* Has a contact lens prescription outside the range of -1.00 to -6.00D
* Has a spectacle cylinder ≥ 1.00D of cylinder in either eye
* Has best corrected spectacle distance vision worse than 20/25 in either eye
* Has any systemic or topical medications that will affect ocular health
* Has any ocular pathology or severe insufficiency of lacrimal secretion
* Has persistent, clinically significant corneal or conjunctival staining
* Has active neovascularization or any central corneal scars
* Is aphakic
* Is presbyopic
* Has undergone corneal refractive surgery
* Is participating in any other type of eye related conical or research study

Primary outcomes:
measure: Visual Acuity (VA) logMAR (Habitual Lenses)
timeFrame: Baseline
measure: Visual Acuity (VA) logMAR (Study Lenses)
timeFrame: Dispense
measure: Comfort Contact Lens Insertion (Day 1 Study Lenses)
timeFrame: Day 1 - Insertion
measure: Comfort Contact Lens 30 Minutes Wear (Day 1 Study Lenses)
timeFrame: Day 1 - 30 minutes
measure: Comfort Contact Lens Insertion (Day 2 Study Lenses)
timeFrame: Day 2 - Insertion
measure: Comfort Contact Lens 30 Minutes Wear (Day 2 Study Lenses)
timeFrame: Day 2 - 30 minutes
measure: Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 1)
timeFrame: Day 1 - Insertion
measure: Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 2)
timeFrame: Day 1 Insertion
measure: Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3)
timeFrame: Day 1 - Insertion
measure: Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)
timeFrame: Day 1 - 30 minutes
measure: Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)
timeFrame: Day 1 - 30 minutes
measure: Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)
timeFrame: Day 1 - 30 minutes
measure: Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 1)
timeFrame: Day 2 - Insertion
measure: Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 2)
timeFrame: Day 2 - Insertion
measure: Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 3)
timeFrame: Day 2 - Insertion
measure: Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)
timeFrame: Day 2 - 30 minutes
measure: Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)
timeFrame: Day 2 - 30 minutes
measure: Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)
timeFrame: Day 2 - 30 minutes
measure: Lens Fitting Characteristics, Centration (Habitual Lens)
timeFrame: Baseline
measure: Lens Fitting Characteristics, Tightness (Habitual Lens)
timeFrame: Baseline
measure: Lens Fitting Characteristics, Upgaze Lag and Post-blink Movement (Habitual Lens)
timeFrame: Baseline
measure: Lens Fitting Characteristics, Centration (Day 1 Study Lenses)
timeFrame: Day 1 - 30 minutes
measure: Lens Fitting Characteristics, Push-up Tightness (Day 1 Study Lenses)
timeFrame: Day 1 - 30 minutes
measure: Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses)
timeFrame: Day 1 - 30 minutes
measure: Lens Fitting Characteristics, Centration (Day 2 Study Lenses)
timeFrame: Day 2 - 30 minutes
measure: Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses)
timeFrame: Day 2 - 30 minutes
measure: Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses)
timeFrame: Day 2 - 30 minutes
measure: Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)
timeFrame: Day 1- 30 minutes
measure: Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)
timeFrame: Day 1- 30 minutes
measure: Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)
timeFrame: Day 1 - 30 minutes
measure: Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)
timeFrame: Day 2 - Insertion
measure: Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)
timeFrame: Day 2 - Insertion
measure: Investigator Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)
timeFrame: Day 2 - Insertion
measure: Overall Ease of Lens Handling (Day 1 Study Lenses)
timeFrame: Day 1 - After Removal
measure: Overall Ease of Lens Handling (Day 2 Study Lenses)
timeFrame: Day 2 - After Removal
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: University of California, Berkeley Clinical Research Center (UCB-CRC)
state: California
Study officials:
affiliation: CRC-UC Berkeley
name: Meng Lin, OD PhD FAAO
role: PRINCIPAL_INVESTIGATOR
References: