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Trial Outcomes & Findings for Effect of Contact Lenses on Tear Osmolarity in a Controlled Low Humidity Chamber (NCT NCT01482312)

NCT ID: NCT01482312

Last Updated: 2012-07-27

Results Overview

The participant spent 90 minutes in the LHE (low humidity environment) chamber, after which tears were sampled from the lower tear meniscus (thin strip of tear fluid at the lower lid margin) and tear osmolarity was measured using a TearLab osmometer, a device that measures the osmolarity of human tears to aid in the diagnosis of dry eye disease. Tear osmolarity is the measure of solid particles (salt) in a solution (tears), and a higher number can be indicative of dry eye disease, while a lower number is generally indicative of the normal tear osmolarity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

29 participants

Primary outcome timeframe

90 minutes

Results posted on

2012-07-27

Participant Flow

Twenty-nine participants were randomized into one of three treatment sequences. The study took place at one site, which was located in Canada.

Participants were instructed to use glasses as a washout from their habitual contact lens brand for at least seven days prior to initiating the first of three LHE (Low-Humidity Environment) chamber visits. This reporting group consists of all enrolled participants.

Participant milestones

Participant milestones
Measure
Lotrafilcon A / Comfilcon A / Glasses
Lotrafilcon A contact lenses worn first, followed by comfilcon A contact lenses, followed by habitual glasses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
Comfilcon A / Glasses / Lotrafilcon A
Comfilcon A contact lenses worn first, followed by glasses, followed by lotrafilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
Glasses / Lotrafilcon A / Comfilcon A
Glasses worn first, followed by lotrafilcon A contact lenses, followed by comfilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
Period 1, 90 Minutes of Wear
STARTED
10
9
10
Period 1, 90 Minutes of Wear
COMPLETED
9
9
10
Period 1, 90 Minutes of Wear
NOT COMPLETED
1
0
0
Period 2, 90 Minutes of Wear
STARTED
9
9
9
Period 2, 90 Minutes of Wear
COMPLETED
8
9
9
Period 2, 90 Minutes of Wear
NOT COMPLETED
1
0
0
Period 3, 90 Minutes of Wear
STARTED
8
9
9
Period 3, 90 Minutes of Wear
COMPLETED
8
9
9
Period 3, 90 Minutes of Wear
NOT COMPLETED
0
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Lotrafilcon A / Comfilcon A / Glasses
Lotrafilcon A contact lenses worn first, followed by comfilcon A contact lenses, followed by habitual glasses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
Comfilcon A / Glasses / Lotrafilcon A
Comfilcon A contact lenses worn first, followed by glasses, followed by lotrafilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
Glasses / Lotrafilcon A / Comfilcon A
Glasses worn first, followed by lotrafilcon A contact lenses, followed by comfilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
Period 1, 90 Minutes of Wear
Other
1
0
0
Period 2, 90 Minutes of Wear
Other
1
0
0

Baseline Characteristics

Effect of Contact Lenses on Tear Osmolarity in a Controlled Low Humidity Chamber

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall
n=29 Participants
This reporting group includes all enrolled participants.
Age Continuous
44.3 years
STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male
Female
21 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 90 minutes

Population: As treated.

The participant spent 90 minutes in the LHE (low humidity environment) chamber, after which tears were sampled from the lower tear meniscus (thin strip of tear fluid at the lower lid margin) and tear osmolarity was measured using a TearLab osmometer, a device that measures the osmolarity of human tears to aid in the diagnosis of dry eye disease. Tear osmolarity is the measure of solid particles (salt) in a solution (tears), and a higher number can be indicative of dry eye disease, while a lower number is generally indicative of the normal tear osmolarity.

Outcome measures

Outcome measures
Measure
Lotrafilcon A Contact Lenses
n=54 Eyes
Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
Comfilcon A Contact Lenses
n=52 Eyes
Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
Glasses
n=54 Eyes
Glasses per habitual prescription
Tear Osmolarity
310 mOsms/L
Standard Deviation 11
313 mOsms/L
Standard Deviation 9
306 mOsms/L
Standard Deviation 11

PRIMARY outcome

Timeframe: 90 minutes

Population: As treated.

Ocular comfort was assessed by the participant after 90 minutes in the LHE and quantified as a linear measure (cm) on a modified Visual Analog Scale (VAS) of 0-20 cm, with a higher number indicating greater perceived comfort.

Outcome measures

Outcome measures
Measure
Lotrafilcon A Contact Lenses
n=54 Eyes
Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
Comfilcon A Contact Lenses
n=54 Eyes
Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
Glasses
n=54 Eyes
Glasses per habitual prescription
Ocular Comfort
9.4 cm
Standard Deviation 3.98
8.2 cm
Standard Deviation 3.30
9.7 cm
Standard Deviation 3.53

Adverse Events

Lotrafilcon A Contact Lenses

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

Comfilcon A Contact Lenses

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

Glasses

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

Director of Alcon Clinical

Alcon Research

Phone: 1-800-241-7629

Results disclosure agreements

  • Principal investigator is a sponsor employee For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.
  • Publication restrictions are in place

Restriction type: OTHER