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Trial Outcomes & Findings for Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses (NCT NCT00934102)

NCT ID: NCT00934102

Last Updated: 2012-07-10

Results Overview

Protein and lipid deposits on the contact lens surface as assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4 with 0 being none and 4 being severe.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

57 participants

Primary outcome timeframe

Period 2, Day 6

Results posted on

2012-07-10

Participant Flow

Of the 57 subjects screened for the study, 11 did not start Period 1 due to personal reasons (7) and non-suitability (4). Period 1 established Day One measurements in order to monitor changes during Period 2.

Participant milestones

Participant milestones
Measure
Narafilcon A / Lotrafilcon A
Narafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
Narafilcon A / Galyfilcon A
Narafilcon A experimental contact lens randomly assigned to one eye, with Galyfilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
Lotrafilcon A / Galyfilcon A
Lotrafilcon A commercial contact lens randomly assigned to one eye, with Galyfilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
Period 1, One Night of Wear
STARTED
16
15
15
Period 1, One Night of Wear
COMPLETED
15
15
15
Period 1, One Night of Wear
NOT COMPLETED
1
0
0
Period 2, 7 Days/6 Nights of Wear
STARTED
15
15
15
Period 2, 7 Days/6 Nights of Wear
COMPLETED
15
15
15
Period 2, 7 Days/6 Nights of Wear
NOT COMPLETED
0
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Narafilcon A / Lotrafilcon A
Narafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
Narafilcon A / Galyfilcon A
Narafilcon A experimental contact lens randomly assigned to one eye, with Galyfilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
Lotrafilcon A / Galyfilcon A
Lotrafilcon A commercial contact lens randomly assigned to one eye, with Galyfilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
Period 1, One Night of Wear
Personal Reasons
1
0
0

Baseline Characteristics

Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall
n=57 Participants
This reporting group includes all subjects who were screened for the study, whether or not they subsequently were dispensed.
Age Continuous
23.23 years
STANDARD_DEVIATION 4.04 • n=93 Participants
Sex: Female, Male
Female
45 Participants
n=93 Participants
Sex: Female, Male
Male
12 Participants
n=93 Participants

PRIMARY outcome

Timeframe: Period 2, Day 6

Population: Per Protocol. Only the data from participants who completed all study visits were analyzed.

Protein and lipid deposits on the contact lens surface as assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4 with 0 being none and 4 being severe.

Outcome measures

Outcome measures
Measure
Lotrafilcon A
n=30 Eyes
Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
Narafilcon A
n=30 Eyes
Investigational, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
Galyfilcon A
n=30 Eyes
Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
Front Surface Lens Deposits
0.68 Units on a Scale
Standard Deviation 0.35
0.78 Units on a Scale
Standard Deviation 0.67
0.77 Units on a Scale
Standard Deviation 0.61

Adverse Events

Lotrafilcon A

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Narafilcon A

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Galyfilcon A

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Craig Woods, PhD, FAAO / Research Manager

University of Waterloo

Phone: 1-519-888-4742

Results disclosure agreements

  • Principal investigator is a sponsor employee No distribution of trial-specific information without express written permission of director.
  • Publication restrictions are in place

Restriction type: OTHER