Ocular Comfort and the "Aging" Lens (ERBIUM)

Ciba Vision

Status

Completed

Conditions

Refractive Error

Treatments

Device: Contact lens cleaning and disinfecting system (ClearCare)

Device: Lotrafilcon B contact lens

Device: Habitual contact lens

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01198600

P-373-C-006

Details and patient eligibility

About

The purpose of this trial was to evaluate the factors affecting comfortable contact lens wear and how those factors affect contact lens replacement frequency.

Full description

Eligible participants began Phase 1, following either Cycle A or Cycle B, and crossing over to the second cycle after completing the first. After the Phase 1 results were evaluated, eligible participants entered Phase 2. After Phase 2 results were evaluated, participants who consistently reported the highest and the lowest comfort scores entered Phase 3 and were defined as either survivors or strugglers.

Enrollment

78 patients

Sex

All

Ages

17+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

At least 17 years of age.
Ocular exam in the last two years.
Currently wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis with a monthly replacement schedule.
Wearing contact lenses at least five days per week for a minimum of 10 hours each day.
Able to wear lenses in the available power range with a best-corrected visual acuity of at least 20/32 in both eyes.
Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Any ocular disease.
Systemic condition that may affect a study outcome.
Using any systemic or topical medications that may affect ocular health.
Wears lenses on an extended or continuous wear schedule.
Habitually wears multifocal lenses.
Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

78 participants in 4 patient groups

Phase 1: Habitual no Replacement, then Habitual Replacement

Other group

Description:

Contact lenses per participant's habitual prescription worn for 30 days with no replacement, followed by contact lenses per habitual prescription worn for 30 days with a replacement pair dispensed at Day 28.

Treatment:

Device: Habitual contact lens

Phase 1: Habitual Replacement, then Habitual no Replacement

Other group

Description:

Contact lenses per participant's habitual prescription worn for 30 days with replacement pair dispensed at Day 28, followed by contact lenses per habitual prescription worn for 30 days with no replacement.

Treatment:

Device: Habitual contact lens

Phase 2: Lotrafilcon B Replacement

Other group

Description:

Contact lenses worn for 56 days with replacement pair dispensed at Day 28.

Treatment:

Device: Lotrafilcon B contact lens

Device: Contact lens cleaning and disinfecting system (ClearCare)

Phase 3: Lotrafilcon B Replacement Replacement

Other group

Description: