Trial Outcomes & Findings for Comparison of Two Silicone Hydrogel Toric Contact Lenses (NCT NCT03392532)

Last Updated: 2019-01-29

Results Overview

Each lens was classified based on whether the absolute difference between the axis location and 90° was less than or equal to 30° (ie, lens axis located between the 60° and 120° axis inclusive). Inferential testing was not planned for this primary effectiveness endpoint.

Recruitment status

COMPLETED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

Day 1, 10 minutes after lens insertion, each product

Results posted on

2019-01-29

Participant Flow

Subjects were recruited from one investigative site located in the US.

This reporting group includes all enrolled subjects (36).

Participant milestones

Participant milestones
Measure	AOHG Toric, Then AO Toric Lotrafilcon B toric contact lenses with HYDRAGLYDE®, followed by lotrafilcon B toric contact lenses, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2.	AO Toric, Then AOHG Toric Lotrafilcon B toric contact lenses, followed by lotrafilcon B toric contact lenses with HYDRAGLYDE®, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2.
Period 1, FIrst 30 Minutes of Wear STARTED	18	18
Period 1, FIrst 30 Minutes of Wear COMPLETED	18	18
Period 1, FIrst 30 Minutes of Wear NOT COMPLETED	0	0
Period 2, Second 30 Minutes of Wear STARTED	18	18
Period 2, Second 30 Minutes of Wear COMPLETED	18	18
Period 2, Second 30 Minutes of Wear NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Two Silicone Hydrogel Toric Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=36 Participants Lotrafilcon B toric contact lenses with HYDRAGLYDE® and lotrafilcon B toric contact lenses worn during Period 1 and Period 2 in a crossover assignment
Age, Continuous	51.5 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1, 10 minutes after lens insertion, each product

Population: Full Analysis Set

Outcome measures

Outcome measures
Measure	AOHG Toric n=72 Eyes Lotrafilcon B toric contact lenses with HYDRAGLYDE® worn in both eyes for approximately 30 minutes during either Period 1 or Period 2, as randomized	AO Toric n=72 Eyes Lotrafilcon B toric contact lenses worn in both eyes for approximately 30 minutes in either Period 1 or Period 2, as randomized
Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location)	94.4 percentage of lenses	95.8 percentage of lenses

Adverse Events

AOHG Toric

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AO Toric

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

CDMA Project Lead, CDMA Vision Care

Alcon, A Novartis Division

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER