PresbyopiaPhase 2NCT05124275
Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Presbyopia
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 Presbyopia, run by Glaukos Corporation at 10 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 Presbyopia. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Presbyopia
- 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
- 123 participants
- Where
- 10 sitesUnited States
- Study dates
- 3 Jan 2022to 6 Sep 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 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presbyopic male or female 40-55 years of age
- Willing and able to provide written informed consent on the IRB/IEC approved informed consent form
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
- History of, or active, iritis or uveitis in either eye
- Pre-existing retinal diseases in either eye that may pre-dispose the subjects to retinal detachment
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Glaukos Investigator
Chandler, Arizona, 85224
Glaukos Investigator
Glendale, California, 91204
Glaukos Investigator
Houston, Texas, 77025
Glaukos Investigator
Louisville, Kentucky, 40206
Glaukos Investigator
Memphis, Tennessee, 38119
Glaukos Investigator
Newport Beach, California, 92663
Glaukos Investigator
Petaluma, California, 94954
Glaukos Investigator
Rochester, New York, 14618
Glaukos Investigator
San Antonio, Texas, 78229
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 Presbyopia
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 Presbyopia.
- Conditions
- Presbyopia
- 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
- Pilocarpine, Refractive errors, Loss of near vision
- Medical subject headings
- Presbyopia, Refractive Errors
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-302
Pilocarpine Ophthalmic Topical Cream, Dose 1
Pilocarpine Ophthalmic Topical Cream, Dose 2Drug
Also called GLK-302
Pilocarpine Ophthalmic Topical Cream, Dose 2
Pilocarpine Ophthalmic Topical Cream, Dose 3Drug
Also called GLK-302
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.
Binocular Distance Corrected Near Visual Acuity (DCNVA)
Proportion of treatment responders [subjects gaining 3 lines or more in binocular distance corrected near visual acuity (DCNVA) and not losing more than 5 letters of binocular best corrected distance visual acuity (BCDVA)] 1 hour post-dose at the Day 28 visit.
Measured: Day 28
Secondary outcomes (1)
Proportion of treatment responders (as defined for the primary endpoint) at 0.5, 2, 4, and 6 hours post-dose at the day 28 visit.
Proportion of treatment responders (as defined for the primary endpoint) at 0.5, 2, 4, and 6 hours post-dose at the day 28 visit.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start3 Jan 2022
- Primary completion6 Sep 2022
- Study completion6 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies 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
- 123 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
- NCT05124275
- Sponsor's protocol ID
- ILUT-401-PRES
- Status last verified
- Aug 2023
- First submitted
- 4 Nov 2021
- Last updated
- 1 Sep 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 1 Sep 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 Presbyopia
- ClinicalTrials.gov ID
- NCT05124275
- Acronym / sponsor ID
- ILUT-401-PRES
- Conditions
- Presbyopia
- Keywords
- Pilocarpine, Refractive errors, Loss of near vision
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 17 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 Presbyopia.
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
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Presbyopic male or female 40-55 years of age
- Willing and able to provide written informed consent on the IRB/IEC approved informed consent form
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
- History of, or active, iritis or uveitis in either eye
- Pre-existing retinal diseases in either eye that may pre-dispose the 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-302Pilocarpine Ophthalmic Topical Cream, Dose 1 | Drug | Pilocarpine Ophthalmic Topical Cream, Dose 1 |
| Pilocarpine Ophthalmic Topical Cream, Dose 2Also: GLK-302Pilocarpine Ophthalmic Topical Cream, Dose 2 | Drug | Pilocarpine Ophthalmic Topical Cream, Dose 2 |
| Pilocarpine Ophthalmic Topical Cream, Dose 3Also: GLK-302Pilocarpine 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
Binocular Distance Corrected Near Visual Acuity (DCNVA)
Time frame: Day 28
Proportion of treatment responders [subjects gaining 3 lines or more in binocular distance corrected near visual acuity (DCNVA) and not losing more than 5 letters of binocular best corrected distance visual acuity (BCDVA)] 1 hour post-dose at the Day 28 visit.
1 secondary outcome
Proportion of treatment responders (as defined for the primary endpoint) at 0.5, 2, 4, and 6 hours post-dose at the day 28 visit.
Time frame: Day 28
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 1 Sep 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.
10 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 Presbyopia, run by Glaukos Corporation at 10 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 2 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 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Binocular Distance Corrected Near Visual Acuity (DCNVA) (time frame: Day 28). 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 1 Sep 2023.