Trial Outcomes & Findings for Ocular Comfort and OCT Observation of Post Lens Clearance and Ocular Tissue Compression (NCT NCT01423773)

Results Overview

Comfort was assessed by the participant on a Visual Analog Scale of 0 to 100, where 0=Extremely Uncomfortable ("My eyes are in pain. I cannot tolerate my lenses") and 100=Extremely Comfortable ("My eyes feel GREAT, better than normal. I cannot feel my lenses").

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Day 2, Hour 10

Results posted on

2013-06-28

Participant Flow

Partipants were recruited from one US study center.

This reporting group includes all enrolled participants.

Participant milestones

Participant milestones
Measure	Lotrafilcon A Test, Then Lotrafilcon A Control Lotrafilcon A test contact lenses worn in Period One, with lotrafilcon A control contact lenses worn in Period Two. Each product was worn bilaterally for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods.	Lotrafilcon A Control, Then Lotrafilcon A Test Lotrafilcon A control contact lenses worn in Period One, with lotrafilcon A test contact lenses worn in Period Two. Each product was worn bilaterally for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods.
Period One, 2 Days STARTED	10	10
Period One, 2 Days COMPLETED	10	10
Period One, 2 Days NOT COMPLETED	0	0
Period 2, 2 Days STARTED	10	10
Period 2, 2 Days COMPLETED	10	10
Period 2, 2 Days NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ocular Comfort and OCT Observation of Post Lens Clearance and Ocular Tissue Compression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=20 Participants Each product worn bilaterally for two consecutive days in either Period One or Period Two. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods.
Age Continuous	36.0 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 2, Hour 10

Population: All enrolled participants

Comfort was assessed by the participant on a Visual Analog Scale of 0 to 100, where 0=Extremely Uncomfortable ("My eyes are in pain. I cannot tolerate my lenses") and 100=Extremely Comfortable ("My eyes feel GREAT, better than normal. I cannot feel my lenses").

Outcome measures

Outcome measures
Measure	Lotrafilcon A Test n=20 Participants Lotrafilcon A test contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.	Lotrafilcon A Control n=20 Participants Lotrafilcon A control contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
Final Comfort	87.6 Units on a scale Standard Deviation 10.5	87.9 Units on a scale Standard Deviation 11.1

Adverse Events

Lotrafilcon A Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lotrafilcon A Control

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

Head, Clinical Trial Management

Alcon Research

Phone: 1-800-241-7629

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place