Health TrialsbyHealthPanel

A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease

ConditionDry Eye Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBausch & Lomb Incorporated

About this trial

A 4-Week, Randomized, Double-Masked, Parallel-Group, Active-Controlled, Multicenter Study Evaluating Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination Administered Twice Daily on Signs and Symptoms of Dry Eye Disease

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily provide written informed consent

≥18 years of age

Subject-reported history of DED OU for at least 6 months

Same eye satisfies the criteria for dry eye signs at both screening and baseline/randomization

Disqualifiers

Known allergy or sensitivity to any study treatment (or any of its components)

Best-corrected visual acuity (BCVA) of 0.7 logarithm of the minimum angle of resolution (logMAR) or worse (50 Early Treatment Diabetic Retinopathy Study [ETDRS] letters; Snellen equivalent score of 20/100 or worse) at Visit 1 (Screening) or Visit 2 (baseline/randomization)

Any clinically significant (CS) ocular surface slit-lamp findings at Visit 1 (Screening) or Visit 2 (baseline/randomization), or findings that may interfere with trial parameters in the opinion of the Investigator.

Use of any of any ocular therapies within 30 days.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lifitegrast/Perfluorohexyloctane Fixed Dose Combination

    Drug

    Topical ocular drop of lifitegrast and perfluorohexyloctane administered for 4 weeks

  • Lifitegrast

    Drug

    Topical ocular drop of lifitegrast administered for 4 weeks

  • Perfluorohexyloctane

    Drug

    Topical ocular drop of perfluorohexyloctane administered for 4 weeks

  • Vehicle

    Drug

    Topical ocular drop with no active ingredients administered for 4 weeks

  • Vehicle

    Drug

    Topical ocular drop with no active ingredients administered for 4 weeks

  • Vehicle

    Drug

    Topical ocular drop with no active ingredients administered for 4 weeks

Treatment groups

423 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Active comparator 1 intervention
Group C: Arm 3Active comparator 1 intervention
Group D: Arm 4Placebo comparator 1 intervention
Group E: Arm 5Placebo comparator 1 intervention
Group F: Arm 6Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total corneal fluorescein staining change from baseline

Time frame
Baseline, day 29

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bausch & Lomb Incorporated

Lead sponsor

Source ClinicalTrials.gov
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