Trial Outcomes & Findings for Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses (NCT NCT01416272)

Results Overview

Symptoms and complaints measured on an analog scale

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

4 visits over 1 year

Results posted on

2014-11-25

Participant Flow

Participant milestones

Participant milestones
Measure	KeraSoft IC Soft Contact Lenses KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months
Overall Study STARTED	12
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	KeraSoft IC Soft Contact Lenses KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months
Overall Study Unacceptable distance visual acuity	2
Overall Study Lost to Follow-up	1
Overall Study Study related complaints	1

Baseline Characteristics

Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	KeraSoft IC Soft Contact Lenses n=12 Participants KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months
Age, Continuous	48 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 visits over 1 year

Population: DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.

Symptoms and complaints measured on an analog scale

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 visits over 1 year

Population: DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.

Low contrast visual acuity measured with high ambient illumination (LCHI)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 visits over 1 year

Population: DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.

High contrast visual acuity measured with high ambient illumination (HCHI)

Outcome measures

Outcome data not reported

Adverse Events

KeraSoft IC Soft Contact Lenses

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

Robert Steffen, OD, MS

Bausch & Lomb / Valeant Pharmaceuticals

Phone: 585-338-6399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place