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A Study to Evaluate the Safety and Effectiveness of a Contact Lens Cleaning and Disinfecting Solution
NA trial testing BL-3100-NBR03 multi-purpose solution in Refractive Ametropia in 295 participants. Completed in 28 February 2024.
| Lead sponsor | Bausch & Lomb Incorporated |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 295 |
| Start date | 12 April 2023 |
| Primary completion | 28 February 2024 |
| Estimated completion | 28 February 2024 |
| Sites | 19 locations across United States |
Bausch & Lomb Incorporated — full company profile →
18 and older, any sex, with Refractive Ametropia. 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
| Group | Value | 95% CI |
|---|---|---|
| BL-3100-NBR03 | 91.7 | ± 9.99 |
| Renu® Advanced Formula | 90.7 | ± 10.83 |
Vision will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response
| Group | Value | 95% CI |
|---|---|---|
| BL-3100-NBR03 | 95.5 | ± 6.69 |
| Renu® Advanced Formula | 94.3 | ± 7.75 |
The degree of front surface deposits will be graded for each eye as: 0 - Absent, clean surface. 1. \- Very slight, only visible after tear film drying. 2. \- Slight, visible deposits easily removable. 3. \- Moderate, deposits adherent and not removable. 4. \- Severe, non-removable deposits and comfort affected.
| Group | Value | 95% CI |
|---|---|---|
| BL-3100-NBR03 | 99.3 | |
| Renu® Advanced Formula | 97.7 |
| Group | Value | 95% CI |
|---|---|---|
| BL-3100-NBR03 | 0.7 | |
| Renu® Advanced Formula | 2.3 |
Graded slit-lamp findings will be assessed for each eye using Grades 0 through 4.
| Group | Value | 95% CI |
|---|---|---|
| BL-3100-NBR03 | 0 | |
| Renu® Advanced Formula | 0.7 |
| Group | Value | 95% CI |
|---|---|---|
| BL-3100-NBR03 | 100 | |
| Renu® Advanced Formula | 99.3 |
Time frame: AE data collected over all scheduled follow-up visits approximately 3 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | BL-3100-NBR03 | Renu® Advanced Formula |
|---|---|---|---|
| Appendicitis | Infections and infestations | — | — |
Most-reported serious reactions: Appendicitis.
Data from ClinicalTrials.gov NCT05565937 adverse events section.
Approximately 340 participants (680 eyes) will be enrolled in this three-month, two-arm, 1:1 randomized, parallel-group, bilateral, double-masked study at approximately 22 investigative sites in the United States. Participants will be required to wear dispensed study lenses on a daily wear basis for three months with scheduled in-office replacement of study lenses at the 1-Month and 2-Month Follow-Up Visits.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing