Trial Outcomes & Findings for CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease in Subjects Who Completed CYS-004 (NCT NCT04523142)

Last Updated: 2023-10-16

Results Overview

An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not the event was considered drug related. 200 participants from the safety set were analyzed.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

202 participants

Primary outcome timeframe

12 months

Results posted on

2023-10-16

Participant Flow

Single arm, open label

Participant milestones

Participant milestones
Measure	CyclASol Ophthalmic Solution Cyclosporine A solution in vehicle CyclASol Ophthalmic Solution: Cyclosporine A solution in vehicle (one drop per eye BID).
Overall Study STARTED	202
Overall Study COMPLETED	175
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease in Subjects Who Completed CYS-004

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CyclASol Ophthalmic Solution n=200 Participants Cyclosporine A solution in vehicle CyclASol Ophthalmic Solution: Cyclosporine A solution in vehicle
Age, Continuous	59 years STANDARD_DEVIATION 14.78 • n=39 Participants
Sex: Female, Male Female	148 Participants n=39 Participants
Sex: Female, Male Male	52 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	175 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	17 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	27 Participants n=39 Participants
Race (NIH/OMB) White	153 Participants n=39 Participants
Race (NIH/OMB) More than one race	2 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=39 Participants
Region of Enrollment United States	200 participants n=39 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	CyclASol Ophthalmic Solution n=200 Participants Cyclosporine A solution in vehicle CyclASol Ophthalmic Solution: Cyclosporine A solution in vehicle
Number of Subjects Reporting Any Adverse Events	97 Participants

Adverse Events

CyclASol Ophthalmic Solution

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CyclASol Ophthalmic Solution n=200 participants at risk Cyclosporine A solution in vehicle CyclASol Ophthalmic Solution: Cyclosporine A solution in vehicle
Nervous system disorders Transient ischemic attach	0.50% 1/200 • Number of events 1 • Data were collected over 52 weeks Ocular and non-ocular AEs were the primary safety endpoints in this study. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not the event was considered drug related.
Nervous system disorders Cerebrovascular Accident	0.50% 1/200 • Number of events 1 • Data were collected over 52 weeks Ocular and non-ocular AEs were the primary safety endpoints in this study. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not the event was considered drug related.
Infections and infestations Pneumonia	1.0% 2/200 • Number of events 2 • Data were collected over 52 weeks Ocular and non-ocular AEs were the primary safety endpoints in this study. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not the event was considered drug related.
Cardiac disorders Atrial Fibrillation	0.50% 1/200 • Number of events 1 • Data were collected over 52 weeks Ocular and non-ocular AEs were the primary safety endpoints in this study. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not the event was considered drug related.
Infections and infestations Cellulitis	0.50% 1/200 • Number of events 1 • Data were collected over 52 weeks Ocular and non-ocular AEs were the primary safety endpoints in this study. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not the event was considered drug related.
Blood and lymphatic system disorders Anemia	0.50% 1/200 • Number of events 1 • Data were collected over 52 weeks Ocular and non-ocular AEs were the primary safety endpoints in this study. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not the event was considered drug related.

Other adverse events

Other adverse events
Measure	CyclASol Ophthalmic Solution n=200 participants at risk Cyclosporine A solution in vehicle CyclASol Ophthalmic Solution: Cyclosporine A solution in vehicle
Eye disorders Instillation site pain	6.5% 13/200 • Data were collected over 52 weeks Ocular and non-ocular AEs were the primary safety endpoints in this study. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not the event was considered drug related.

Additional Information

Sonja Krösser

Novaliq GmbH

Phone: +49 6221 50259

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60