Bausch & Lomb completes Phase 2 test of lifitegrast-perfluorohexyloctane combo for dry eye
The 443-patient trial finished on schedule with results not yet posted, leaving open whether pairing two established dry-eye mechanisms beats either alone.
Executive Summary
- Bausch & Lomb finished enrollment and closed out a mid-stage trial testing whether combining two dry-eye mechanisms in one fixed dose outperforms either used alone.
- Both components already carry FDA approval as standalone dry-eye treatments, so the trial's real test is whether pairing them adds benefit rather than whether the underlying biology works.
- The trial completed at its enrollment target with no completion delay, exactly the outcome a Phase 2 program is designed to produce, and the open question shifts entirely to the data.
- The LFA-1-in-dry-eye pairing has a documented high termination rate among prior industry programs, though Bausch & Lomb's own broader ocular-surface portfolio has completed at a high rate.
The trial
NCT07128628 tested a fixed-dose combination of lifitegrast, the LFA-1 inhibitor marketed by Bausch & Lomb as Xiidra, and perfluorohexyloctane, an evaporative-barrier agent, in adults with dry eye disease. The study started recruiting on October 24, 2025, and moved to Completed status on July 14, 2026, with enrollment finalized at 443 patients against a target of 443, an exact match rather than a shortfall or overshoot. The primary endpoint is total corneal fluorescein staining change from baseline, measured at day 29 against baseline, a standard structural marker of ocular surface damage in dry eye trials. NCT07128628A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye DiseaseNCT07128628
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What it tests
Lifitegrast already carries FDA approval as Xiidra, an ophthalmic solution for dry eye disease, and perfluorohexyloctane already works as a standalone evaporative barrier in the same indication. Because both components have established single-agent profiles, this trial is not testing a novel mechanism. It is testing whether fixing the two together in one dose produces a result that exceeds what either has shown separately, the bridging question that governs how far a combination product can differentiate from its parts.
Operational read
The trial's enrollment count moved from an anticipated 423 to an actual 443 patients as it closed, a change the operational risk model treats as a routine registry update rather than a shift, since it falls far under the 20% threshold the model uses to flag an enrollment change. The trial completed without any change to its primary completion date, which had been guided at May 28, 2026 and held there. No results have posted to the public registry yet, which is expected timing for a trial that closed its Completed status the same week this update was recorded. NCT07128628A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye DiseaseNCT07128628
The field
Among industry trials pairing LFA-1 as a target with dry eye disease as the indication, 2 have completed and 5 have terminated, a termination rate of 71% across 4 distinct sponsors. That difficulty sits mostly with programs testing lifitegrast or related LFA-1 approaches as monotherapy or in different formulations; the closest direct comparator with an identical target and modality is a Phase 4 lifitegrast biomarker study from the Pittsburgh Research Institute. Bausch & Lomb's own track record across its broader ocular-surface portfolio shows a high completion rate on 12 trials, and its global trial base completed 188 of 198 trials, a completion rate near 95%. NCT07128628A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye DiseaseNCT07128628
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.