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Investigational Lubricating Eye in a Novelia bottle

Phase 2

Dry Eye | Small molecule | Ophthalmology |Johnson & Johnson|Last Updated: Apr 27, 2025

Target and mechanism

ModalitySmall molecule

Also known as Investigational Lubricating Eye Drop in a Novelia® bottle

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment121

FDA Designations

No designations recorded

Clinical trial landscape

Investigational Lubricating Eye in a Novelia bottle · 1 trial · 1 indication

Phase 2 1
NCT05661851Clinical Evaluation of a Multidose Preservative-free Lubricating Eye Drops Contained in Novelia® Eye Dropper in Non-Contact Lens Wearing PatientsDry Eye
COMPLETED121 Analytics
PHASE2COMPLETED
Clinical Evaluation of a Multidose Preservative-free Lubricating Eye Drops Contained in Novelia® Eye Dropper in Non-Contact Lens Wearing Patients
Dry EyeUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Overall Quality of Ocular Comfort From Baseline to 30-Day Follow-Up Using VAS Scores
Baseline and 30-Day Follow-up

Subjective ocular comfort was assessed at baseline, and at 30-day follow-up using a Visual Analogue Scale (VAS) with continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular comfort score was calculated as 30-day follow-up score minus baseline score. Change from baseline VAS scores range from -100 to 100, where higher change from baseline comfort scores indicates better performance. The average change from baseline comfort score for each Arm was reported.

Secondary Endpoints

Change in Overall Quality of Vision From Baseline to 30-Day Follow-Up Using VAS Scores
Baseline and 30-Day Follow-up
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Investigational productEXPERIMENTALEligible subjects will be randomly assigned the investigational product to be used in both eyes for the duration of the study.
Control productACTIVE_COMPARATOREligible subjects will be randomly assigned the control product to be used in both eyes for the duration of the study

Interventions

NameTypeDescription
Investigational Lubricating Eye Drop in a Novelia® bottleDRUGInvestigational Product
Blink® Tears eye DropsDRUGControl Product
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Eligibility Criteria

Age Range18 Years to 69 Years
SexALL
Healthy VolunteersYes
Study Sites8

Inclusion Criteria: Potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. Appear able and willing to adhere to the instructions set forth in this c...

Countries:United States
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