Dry Eye DiseasePhase 2NCT05119920
Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Dry Eye Disease
A Phase 2 study testing Pilocarpine Ophthalmic Topical Cream, Dose 1, Pilocarpine Ophthalmic Topical Cream, Dose 2 and Pilocarpine Ophthalmic Topical Cream, Dose 3 in people with Dry Eye Disease and Kerato Conjunctivitis Sicca, run by Glaukos Corporation at 19 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease, Kerato Conjunctivitis Sicca
- What is being tested?
- Pilocarpine Ophthalmic Topical Cream, Dose 1, Pilocarpine Ophthalmic Topical Cream, Dose 2 and Pilocarpine Ophthalmic Topical Cream, Dose 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 226 participants
- Where
- 19 sitesUnited States
- Study dates
- 3 Jan 2022to 27 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 years of age or older at the Screening Visit
- Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form
- Diagnosis of dry eye
Who cannot join
- Sensitivity or known allergy to pilocarpine or any of the other excipients of the formulation
- History of eczema, dermatitis or skin sensitivity to over-the-counter personal care products such as lotions, creams, makeup, soaps, etc.
- History of, or active iritis or uveitis in either eye
- Pre-existing retinal disease in either eye that may predispose subjects to retinal detachment
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Glaukos Investigator
Chandler, Arizona, 85224
Glaukos Investigator
Cranberry Township, Pennsylvania, 16066
Glaukos Investigator
Fort Myers, Florida, 33901
Glaukos Investigator
Glendale, California, 91204
Glaukos Investigator
Grand Junction, Colorado, 81501
Glaukos Investigator
Henderson, Nevada, 89052
Glaukos Investigator
Houston, Texas, 77025
Glaukos Investigator
Lynchburg, Virginia, 24502
Glaukos Investigator
Memphis, Tennessee, 38119
Glaukos Investigator
Mission Hills, California, 91345
Glaukos Investigator
Nashville, Tennessee, 37215
Glaukos Investigator
Newport Beach, California, 92663
Glaukos Investigator
Petaluma, California, 94954
Glaukos Investigator
Rancho Cordova, California, 95670
Glaukos Investigator
Rochester, New York, 14618
Glaukos Investigator
Roswell, Georgia, 30076
Glaukos Investigator
San Antonio, Texas, 78229
Glaukos Investigator
St Louis, Missouri, 63131
Glaukos Investigator
Sun City, Arizona, 85351
About this study
Official title: Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream BID for the Treatment of Signs and Symptoms of Dry Eye Disease
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.
- Conditions
- Dry Eye Disease, Kerato Conjunctivitis Sicca
- Being tested
- Pilocarpine Ophthalmic Topical Cream, Dose 1, Pilocarpine Ophthalmic Topical Cream, Dose 2, Pilocarpine Ophthalmic Topical Cream, Dose 3, Placebo Ophthalmic Topical Cream
- Keywords
- Dry eye syndromes, Eye diseases, Corneal diseases, Keratoconjunctivitis, Pilocarpine
- Medical subject headings
- Dry Eye Syndromes, Eye Diseases, Corneal Diseases, Keratoconjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilocarpine Ophthalmic Topical Cream, Dose 1Drug
Also called GLK-301
Pilocarpine Ophthalmic Topical Cream, Dose 1
Pilocarpine Ophthalmic Topical Cream, Dose 2Drug
Also called GLK-301
Pilocarpine Ophthalmic Topical Cream, Dose 2
Pilocarpine Ophthalmic Topical Cream, Dose 3Drug
Also called GLK-301
Pilocarpine Ophthalmic Topical Cream, Dose 3
Placebo Ophthalmic Topical CreamDrug
Also called Placebo
Placebo Ophthalmic Topical Cream
| Study group | Role | What they receive |
|---|---|---|
| Pilocarpine Ophthalmic Topical Cream, Dose 1 | Experimental | Pilocarpine Ophthalmic Topical Cream, Dose 1 Receives: Drug: Pilocarpine Ophthalmic Topical Cream, Dose 1 |
| Pilocarpine Ophthalmic Topical Cream, Dose 2 | Experimental | Pilocarpine Ophthalmic Topical Cream, Dose 2 Receives: Drug: Pilocarpine Ophthalmic Topical Cream, Dose 2 |
| Pilocarpine Ophthalmic Topical Cream, Dose 3 | Experimental | Pilocarpine Ophthalmic Topical Cream, Dose 3 Receives: Drug: Pilocarpine Ophthalmic Topical Cream, Dose 3 |
| Placebo Ophthalmic Topical Cream | Placebo comparator | Placebo Ophthalmic Topical Cream Receives: Drug: Placebo Ophthalmic Topical Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: Baseline and Day 28
Secondary outcomes (1)
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)
Measured: Baseline and Days 4, 8, and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start3 Jan 2022
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Glaukos CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119920
- Sponsor's protocol ID
- ILUT-401-DED
- Status last verified
- Jul 2023
- First submitted
- 3 Nov 2021
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream BID for the Treatment of Signs and Symptoms of Dry Eye Disease
- ClinicalTrials.gov ID
- NCT05119920
- Acronym / sponsor ID
- ILUT-401-DED
- Conditions
- Dry Eye Disease, Kerato Conjunctivitis Sicca
- Keywords
- Dry eye syndromes, Eye diseases, Corneal diseases, Keratoconjunctivitis, Pilocarpine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pilocarpine Ophthalmic Topical Cream, Dose 1 | Experimental | Drug: Pilocarpine Ophthalmic Topical Cream, Dose 1Pilocarpine Ophthalmic Topical Cream, Dose 1 |
| Pilocarpine Ophthalmic Topical Cream, Dose 2 | Experimental | Drug: Pilocarpine Ophthalmic Topical Cream, Dose 2Pilocarpine Ophthalmic Topical Cream, Dose 2 |
| Pilocarpine Ophthalmic Topical Cream, Dose 3 | Experimental | Drug: Pilocarpine Ophthalmic Topical Cream, Dose 3Pilocarpine Ophthalmic Topical Cream, Dose 3 |
| Placebo Ophthalmic Topical Cream | Placebo comparator | Drug: Placebo Ophthalmic Topical CreamPlacebo Ophthalmic Topical Cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, 18 years of age or older at the Screening Visit
- Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form
- Diagnosis of dry eye
Key exclusion criteria (4 listed)
- Sensitivity or known allergy to pilocarpine or any of the other excipients of the formulation
- History of eczema, dermatitis or skin sensitivity to over-the-counter personal care products such as lotions, creams, makeup, soaps, etc.
- History of, or active iritis or uveitis in either eye
- Pre-existing retinal disease in either eye that may predispose subjects to retinal detachment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilocarpine Ophthalmic Topical Cream, Dose 1Also: GLK-301Pilocarpine Ophthalmic Topical Cream, Dose 1 | Drug | Pilocarpine Ophthalmic Topical Cream, Dose 1 |
| Pilocarpine Ophthalmic Topical Cream, Dose 2Also: GLK-301Pilocarpine Ophthalmic Topical Cream, Dose 2 | Drug | Pilocarpine Ophthalmic Topical Cream, Dose 2 |
| Pilocarpine Ophthalmic Topical Cream, Dose 3Also: GLK-301Pilocarpine Ophthalmic Topical Cream, Dose 3 | Drug | Pilocarpine Ophthalmic Topical Cream, Dose 3 |
| Placebo Ophthalmic Topical CreamAlso: PlaceboPlacebo Ophthalmic Topical Cream | Drug | Placebo Ophthalmic Topical Cream |
Primary outcome
Mean change from baseline in the VAS score at Day 28 visit.
Time frame: Baseline and Day 28
Mean change from baseline in the VAS score at Day 28 visit. Visual Analogue Scale from 0 (no discomfort) to 100 (maximal discomfort)
Mean change from baseline in Fluorescein Staining at the Day 28 visit.
Time frame: Baseline and Day 28
Mean change from baseline in Fluorescein Staining at the Day 28 visit.
1 secondary outcome
Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits
Time frame: Baseline and Days 4, 8, and 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pilocarpine Ophthalmic Topical Cream, Dose 1, Pilocarpine Ophthalmic Topical Cream, Dose 2 and Pilocarpine Ophthalmic Topical Cream, Dose 3 in people with Dry Eye Disease and Kerato Conjunctivitis Sicca, run by Glaukos Corporation at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in the VAS score at Day 28 visit. (time frame: Baseline and Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.