Health TrialsbyHealthPanel

Evaluation of the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis

ConditionDemodex Blepharitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlaukos Corporation

About this trial

This is a randomized, double-masked, placebo-controlled, dose-ranging, parallel-group, multi-center study designed to evaluate the safety and efficacy of GLK-321 in patients with Demodex blepharitis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signs of Demodex blepharitis in at least one eye

Best Spectacle Corrected Visual Acuity (BSCVA) of 20/80 Snellen or better in each eye

Disqualifiers

Presence of eczema or dermatitis in the ocular region of either eye

Use of lid hygiene products within 14 days of Screening

Active ocular infection or inflammation, other than blepharitis, in either eye at Screening

Women who are pregnant, planning a pregnancy, or nursing

Trial design

Design model

Parallel

Treatments tested in this trial

  • GLK-321 low dose BID

    Drug

    Twice daily administration of low dose GLK-321 to both eyes

  • GLK-321 mid dose BID

    Drug

    Twice daily administration of mid dose GLK-321 to both eyes

  • GLK-321 high dose BID

    Drug

    Twice daily administration of high dose GLK-321 to both eyes

  • GLK-321 high dose QD

    Drug

    Once daily administration of high dose GLK-321 to both eyes

  • Placebo BID

    Drug

    Twice daily administration of placebo to both eyes

Treatment groups

250 Participants
are divided into 5 treatment groups
Group A: GLK-321 low dose BIDExperimental treatment 1 intervention
Group B: GLK-321 mid dose BIDExperimental treatment 1 intervention
Group C: GLK-321 high dose BIDExperimental treatment 1 intervention
Group D: GLK-321 high dose QDExperimental treatment 1 intervention
Group E: Placebo BIDPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of study eyes with elimination of collarettes

Percentage of study eyes that had eyelash collarettes due to Demodex blepharitis at the onset of treatment who demonstrate absence of collarettes after 6 weeks of treatment

Time frame
6 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Glaukos Corporation

Lead sponsor

Source ClinicalTrials.gov
Apply now