Trial Outcomes & Findings for Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study) (NCT NCT04140227)

NCT ID: NCT04140227

Last Updated: 2024-03-04

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 256 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2024-03-04

Participant Flow

Participant milestones

Measure	NOV03 4 Times Daily (QID) 100% Perfluorohexyloctance solution 4 times daily (QID) NOV03: 100% Perfluorohexyloctane
Overall Study STARTED	256
Overall Study COMPLETED	208
Overall Study NOT COMPLETED	48

Reasons for withdrawal

Measure	NOV03 4 Times Daily (QID) 100% Perfluorohexyloctance solution 4 times daily (QID) NOV03: 100% Perfluorohexyloctane
Overall Study Withdrawal by Subject	26
Overall Study Lost to Follow-up	8
Overall Study Adverse Event	8
Overall Study Death	1
Overall Study Other	3
Overall Study Protocol Violation	2

Baseline Characteristics

Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)

Baseline characteristics by cohort

Measure	Single-arm Open Label n=208 Participants single-arm open label
Age, Continuous	61.2 Years STANDARD_DEVIATION 13.02 • n=5 Participants
Sex: Female, Male Female	146 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	29 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	43 Participants n=5 Participants
Race (NIH/OMB) White	133 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Type of Eyes Right Eye	121 Participants n=5 Participants
Type of Eyes Left Eye	87 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	NOV03 4 Times Daily (QID) n=208 Participants 100% Perfluorohexyloctance solution 4 times daily (QID) NOV03: 100% Perfluorohexyloctane
Number of Participants With Ocular and Non-ocular Adverse Events At Least 1 TEAE Ocular and non-Ocular	69 Participants
Number of Participants With Ocular and Non-ocular Adverse Events At Least 1 IP-related TEAE Ocular and non-Ocular	14 Participants
Number of Participants With Ocular and Non-ocular Adverse Events At Least 1 SAE Ocular and non-Ocular	1 Participants
Number of Participants With Ocular and Non-ocular Adverse Events TEAE that led to Drug Withdrawal	9 Participants

Adverse Events

NOV03 4 Times Daily (QID)

Serious events: 10 serious events

Other events: 44 other events

Deaths: 1 deaths

Serious adverse events

Measure	NOV03 4 Times Daily (QID) n=208 participants at risk 100% Perfluorohexyloctance solution 4 times daily (QID) NOV03: 100% Perfluorohexyloctane
Gastrointestinal disorders Severe Gastric Cancer	0.48% 1/208 • Number of events 1 • AE information was captured during the duration of the study of 1 year
Respiratory, thoracic and mediastinal disorders pulmonary embolism	0.48% 1/208 • Number of events 1 • AE information was captured during the duration of the study of 1 year
Metabolism and nutrition disorders hypoglcaemia	0.48% 1/208 • Number of events 1 • AE information was captured during the duration of the study of 1 year
Injury, poisoning and procedural complications femur fracture	0.48% 1/208 • Number of events 1 • AE information was captured during the duration of the study of 1 year
Injury, poisoning and procedural complications radius fracture	0.48% 1/208 • Number of events 1 • AE information was captured during the duration of the study of 1 year
Injury, poisoning and procedural complications tibia fracture	0.48% 1/208 • Number of events 1 • AE information was captured during the duration of the study of 1 year
Injury, poisoning and procedural complications ulna fracture	0.48% 1/208 • Number of events 1 • AE information was captured during the duration of the study of 1 year
Cardiac disorders transient ischaemic attack	0.48% 1/208 • Number of events 1 • AE information was captured during the duration of the study of 1 year
Psychiatric disorders schizophrenia	0.48% 1/208 • Number of events 1 • AE information was captured during the duration of the study of 1 year
Musculoskeletal and connective tissue disorders spinal osteoarthritis	0.48% 1/208 • Number of events 1 • AE information was captured during the duration of the study of 1 year
Respiratory, thoracic and mediastinal disorders emphysema	0.48% 1/208 • Number of events 1 • AE information was captured during the duration of the study of 1 year
Nervous system disorders cerebrovascular accident	0.48% 1/208 • Number of events 1 • AE information was captured during the duration of the study of 1 year

Other adverse events

Measure	NOV03 4 Times Daily (QID) n=208 participants at risk 100% Perfluorohexyloctance solution 4 times daily (QID) NOV03: 100% Perfluorohexyloctane
Infections and infestations Sinusitis	0.96% 2/208 • AE information was captured during the duration of the study of 1 year
Infections and infestations COVID-19	2.9% 6/208 • AE information was captured during the duration of the study of 1 year
Infections and infestations Urinary Tract Infection	0.96% 2/208 • AE information was captured during the duration of the study of 1 year
Vascular disorders Hypertension	1.9% 4/208 • AE information was captured during the duration of the study of 1 year
Eye disorders Vitreous detachment	1.9% 4/208 • AE information was captured during the duration of the study of 1 year
Eye disorders Conjuctivitis allergic	1.4% 3/208 • AE information was captured during the duration of the study of 1 year
Eye disorders Lacrimation increased	1.4% 3/208 • AE information was captured during the duration of the study of 1 year
Eye disorders Vision blurred	1.4% 3/208 • AE information was captured during the duration of the study of 1 year
Eye disorders Dry eye	0.96% 2/208 • AE information was captured during the duration of the study of 1 year
General disorders Instillation site pain	0.96% 2/208 • AE information was captured during the duration of the study of 1 year
Infections and infestations Hordeolum	0.96% 2/208 • AE information was captured during the duration of the study of 1 year
Eye disorders Chalazion	0.96% 2/208 • AE information was captured during the duration of the study of 1 year
Metabolism and nutrition disorders Hypercholesterolaemia	1.4% 3/208 • AE information was captured during the duration of the study of 1 year
Musculoskeletal and connective tissue disorders Arthralgia	0.96% 2/208 • AE information was captured during the duration of the study of 1 year
Nervous system disorders Neuralgia	0.96% 2/208 • AE information was captured during the duration of the study of 1 year
Psychiatric disorders Insomnia	0.96% 2/208 • AE information was captured during the duration of the study of 1 year

Additional Information

Johnson Varughese VP Clinical Services

Bausch and Lomb

Phone: 908-927-1162

Email: johnson.varughese@bausch.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place