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Blink Tears eye · 2 trials · 2 indications
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.
High contrast bright illumination monocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicate better vision. The average logMAR visual acuity for each treatment was reported.
High contrast bright illumination monocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicate better vision. The average logMAR visual acuity for each treatment was reported.
| Arm | Type | Description |
|---|---|---|
| Investigational product | EXPERIMENTAL | Eligible subjects will be randomly assigned the investigational product to be used in both eyes for the duration of the study. |
| Control product | ACTIVE_COMPARATOR | Eligible subjects will be randomly assigned the control product to be used in both eyes for the duration of the study |
| Test/Control | EXPERIMENTAL | Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to receive the TEST lubricating eye drops, with a washout period of 90 minutes between instillations. After the wash-out period, the CONTROL lubricating eye drops will be instilled. |
| Control/Test | EXPERIMENTAL | Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to receive the CONTROL lubricating eye drops, with a washout period of 90 minutes between instillations. After the wash-out period, the TEST lubricating eye drops will be instilled. |
| Name | Type | Description |
|---|---|---|
| Investigational Lubricating Eye Drop in a Novelia® bottle | DRUG | Investigational Product |
| Blink® Tears eye Drops | DRUG | Control Product |
| Investigational lipid eye drops | DRUG | Test Drops |
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...
Blink Tears eye is a small molecule lubricating eye drop developed for use in dry eye and for evaluating visual acuity in contact lens wearers. It is an investigational product in clinical development by Johnson & Johnson (NYSE: JNJ).
Blink Tears eye is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical trials to evaluate the product in patients with dry eye and in contact lens wearers.
Blink Tears eye is in Phase 2 clinical development. One Phase 2 trial has been completed, and a Phase 1 trial has also been completed. The product is investigational and has not been approved by the FDA.
Blink Tears eye has been studied in two completed clinical trials. NCT05661851 was a Phase 2 trial in 121 patients with dry eye, and NCT06131476 was a Phase 1 trial in 32 contact lens wearers evaluating visual acuity. Both trials were conducted in the United States.
Blink Tears eye is a multidose, preservative-free lubricating eye drop that uses the Novelia eye dropper system. It is a lipid-based formulation designed for use in patients with dry eye and in contact lens wearers.