Health TrialsbyHealthPanel

Placebo-controlled Study to Evaluate the Safety and Efficacy of GLK-221 Ophthalmic Solution in Subjects With Keratoconus

ConditionKeratoconus
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorGlaukos Corporation

About this trial

Multi-center, parallel-group, placebo-controlled trial designed to assess the safety and efficacy of twice-daily topically administered GLK-221 Ophthalmic Solution in subjects with keratoconus.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be ≥ 18 and ≤ 55 years of age

Diagnosis of keratoconus in the study eye

Disqualifiers

Pregnant, lactating or planning a pregnancy

Currently enrolled, or within 30 days prior to Screening were enrolled, in another investigational drug or device trial

Trial design

Design model

Parallel

Treatments tested in this trial

  • GLK-221 Ophthalmic Solution

    Drug

    GLK-221 Ophthalmic Solution administered twice daily to both eyes

  • Placebo Ophthalmic Solution

    Drug

    Placebo Ophthalmic Solution administered twice daily to both eyes

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: GLK-221 Ophthalmic SolutionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean change from baseline in maximum corneal curvature

Mean change from baseline in maximum corneal curvature

Time frame
16 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
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