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A Safety and Effectiveness Study of a New Preservative Free Rewetting Drop
NA trial testing BL-300-PFM04 in Contact Lens Wear in 369 participants. Completed in 17 February 2020.
| Lead sponsor | Bausch & Lomb Incorporated |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 369 |
| Start date | 7 November 2019 |
| Primary completion | 17 February 2020 |
| Estimated completion | 17 February 2020 |
| Sites | 15 locations across United States |
Bausch & Lomb Incorporated — full company profile →
18 and older, any sex, with Contact Lens Wear. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response. For each eye, mean overall comfort over all follow-up visits will be computed as the average of the non-missing values overall scheduled follow-up visits.
| Group | Value | 95% CI |
|---|---|---|
| BL-300-PFM04 | 91.72 | ± 9.988 |
| Lubricating and Rewetting Drops | 91.54 | ± 10.680 |
Dryness will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response. For each eye, mean dryness over all follow-up visits will be computed as the average of the non-missing values over all scheduled follow-up visits.
| Group | Value | 95% CI |
|---|---|---|
| BL-300-PFM04 | 87.91 | ± 13.332 |
| Lubricating and Rewetting Drops | 87.01 | ± 14.650 |
At each follow-up visit, graded slit lamp findings will be assessed for each eye using Grades 0 through 4. Using only the non-missing observations from all visits without imputation, each eye will be classified with respect to findings greater than grade 2 at any visit (Absent, Present).
| Group | Value | 95% CI |
|---|---|---|
| BL-300-PFM04 | 0 | |
| Lubricating and Rewetting Drops | 0 |
The objective of this study is to evaluate the safety and effectiveness of lubricating and rewetting drop (Test) compared to OPTI-FREE® Replenish® Rewetting Drops (Control) when used by habitual contact lens wearers to bilaterally lubricate and rewet soft (hydrophilic) contact lenses including silicone hydrogel contact lenses and gas permeable (silicone acrylate and fluoro silicone acrylate) contact lenses.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04175340.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing