A Phase 2 interventional study of Pilocarpine Ophthalmic Topical Cream, Dose 1 and Pilocarpine Ophthalmic Topical Cream, Dose 2 in Dry Eye Disease and Kerato Conjunctivitis Sicca, sponsored by Glaukos Corporation. Completed at 19 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-12.
Sponsored by Glaukos Corporation · Phase 2, Interventional, and Treatment
This is a Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Signs and Symptoms of Dry Eye Disease.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 226 is above the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Glaukos Corporation is the lead sponsor of 67 studies on the registry; 14 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pilocarpine Ophthalmic Topical Cream, Dose 1
Drug: Pilocarpine Ophthalmic Topical Cream, Dose 1
Pilocarpine Ophthalmic Topical Cream, Dose 2
Drug: Pilocarpine Ophthalmic Topical Cream, Dose 2
Pilocarpine Ophthalmic Topical Cream, Dose 3
Drug: Pilocarpine Ophthalmic Topical Cream, Dose 3
Placebo Ophthalmic Topical Cream
Drug: Placebo Ophthalmic Topical Cream
Pilocarpine Ophthalmic Topical Cream, Dose 1
Also known as: GLK-301
Pilocarpine Ophthalmic Topical Cream, Dose 2
Also known as: GLK-301
Pilocarpine Ophthalmic Topical Cream, Dose 3
Also known as: GLK-301
Placebo Ophthalmic Topical Cream
Also known as: Placebo
Mean change from baseline in the VAS score at Day 28 visit.
Mean change from baseline in the VAS score at Day 28 visit. Visual Analogue Scale from 0 (no discomfort) to 100 (maximal discomfort)
Time frame: Baseline and Day 28
Mean change from baseline in Fluorescein Staining at the Day 28 visit.
Mean change from baseline in Fluorescein Staining at the Day 28 visit.
Time frame: Baseline and Day 28
Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits
Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits Visual Analogue Scale from 0 (no discomfort) to 100 (maximal discomfort)
Time frame: Baseline and Days 4, 8, and 14
Plan to share: No
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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