Dry Eye DiseasePhase 1/2NCT04201574
Phase 1/2a Safety and Efficacy of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease
A Phase 1/2 study testing ALY688 0.1% and ALY688 0.4% in people with Dry Eye Disease, run by Allysta Pharmaceutical at 1 site in United States.
Trial summary
Clinical Trial Evaluating the Safety and Tolerability of ALY688 in Subjects with 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
- What is being tested?
- ALY688 0.1% and ALY688 0.4%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2019to 15 Sep 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Dry eye disease for > 3 months meeting specific sign and symptom criteria
- Best correct visual acuity of +0.6 logMAR or better
- Willing to sign informed consent and attend study visits
- Willing to comply with contraception requirements
Who cannot join
- Unable to meet specific sign and symptom criteria
- Signs of ophthalmic allergic, inflammatory or infectious conditions
- Use of contact lenses
- Anatomic abnormalities preventing accurate study assessments
- Use of medications that influence eye dryness
- Recent ophthalmic surgery
- Unwilling to suspend current treatments for dry eye disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1/2a, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Exploratory Activity of Two Concentrations of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease
Clinical Trial Evaluating the Safety and Tolerability of ALY688 in Subjects with Dry Eye Disease
Read the detailed description
This is a multi-center, randomized, double-masked Phase 1/2a trial designed to evaluate the safety and tolerability of ALY688 Ophthalmic Solution in subjects with moderate to mildly severe dry eye for 8 weeks with 6 scheduled clinic visits.
- Conditions
- Dry Eye Disease
- Being tested
- ALY688 0.1%, ALY688 0.4%, Vehicle
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALY688 0.1%Drug
Also called ALY688 Ophthalmic
ALY688 0.1% Ophthalmic Solution
ALY688 0.4%Drug
Also called ALY688 Ophthalmic
ALY688 0.4% Ophthalmic Solution
VehicleDrug
Also called placebo
Vehicle Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | Vehicle Ophthalmic Solution Receives: Drug: Vehicle |
| ALY688 0.1% | Experimental | ALY688 0.1% Ophthalmic Solution Receives: Drug: ALY688 0.1% |
| ALY688 0.4% | Experimental | ALY688 0.4%Ophthalmic Solution Receives: Drug: ALY688 0.4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Adverse Events
Subjects reporting any treatment-emergent adverse events
Measured: 8 weeks
Eye Dryness Score (7-Day Average)
Mean change from baseline in eye dryness score (7-day average) using a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse
Measured: 8 weeks
Corneal Fluorescein Staining
Mean change from baseline in zonal corneal fluorescein staining score in study eye using a 0- to 4-unit clinical grading scale, with 0 being better and 4 being worse
Measured: 8 weeks
Secondary outcomes (6)
Ocular Discomfort Score by Visual Analog Scale
Mean change from baseline in ocular discomfort score of 7-day average using a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse
Measured: 8 weeks
Symptom Assessment in Dry Eye (SAnDE) Score Assessment
Mean change from baseline in Symptom Assessment in Dry Eye global symptom score on a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse. Global symptom score is calculated as the square root of the frequency score time the severity score per visit
Measured: 8 weeks
Conjunctival Lissamine Green Staining
Mean change from baseline in zonal conjunctival lissamine green staining in study eye using a 0- to 4-unit clinical grading scale, with 0 being better and 4 being worse
Measured: 8 weeks
Conjunctival Hyperemia Grading
Mean change from baseline in zonal conjunctival hyperemia in study eye using a 0- to 4-unit clinical grading scale and standardized grading photos, with 0 being better and 4 being worse
Measured: 8 weeks
Tear Film Break-up Time (TBUT)
Mean change from baseline in TBUT in study eye
Measured: 8 weeks
Schirmer's Test
Mean change from baseline in tear volume in study eye as assessed by unanesthetized Schirmer test
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start16 Dec 2019
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allysta Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henry Hsu, MD, Study director, Allysta Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201574
- Sponsor's protocol ID
- ALY688-201
- Status last verified
- May 2023
- First submitted
- 12 Dec 2019
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Exploratory Activity of Two Concentrations of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT04201574
- Acronym / sponsor ID
- ALY688-201
- Conditions
- Dry Eye Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Allysta PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 17 Dec 2019 (actual)
- Results
- Posted 22 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical Trial Evaluating the Safety and Tolerability of ALY688 in Subjects with Dry Eye Disease
Detailed description
This is a multi-center, randomized, double-masked Phase 1/2a trial designed to evaluate the safety and tolerability of ALY688 Ophthalmic Solution in subjects with moderate to mildly severe dry eye for 8 weeks with 6 scheduled clinic visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Drug: VehicleVehicle Ophthalmic Solution |
| ALY688 0.1% | Experimental | Drug: ALY688 0.1%ALY688 0.1% Ophthalmic Solution |
| ALY688 0.4% | Experimental | Drug: ALY688 0.4%ALY688 0.4%Ophthalmic Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Dry eye disease for > 3 months meeting specific sign and symptom criteria
- Best correct visual acuity of +0.6 logMAR or better
- Willing to sign informed consent and attend study visits
- Willing to comply with contraception requirements
Key exclusion criteria (7 listed)
- Unable to meet specific sign and symptom criteria
- Signs of ophthalmic allergic, inflammatory or infectious conditions
- Use of contact lenses
- Anatomic abnormalities preventing accurate study assessments
- Use of medications that influence eye dryness
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 |
|---|---|---|
| ALY688 0.1%Also: ALY688 OphthalmicALY688 0.1% Ophthalmic Solution | Drug | ALY688 0.1% |
| ALY688 0.4%Also: ALY688 OphthalmicALY688 0.4% Ophthalmic Solution | Drug | ALY688 0.4% |
| VehicleAlso: placeboVehicle Ophthalmic Solution | Drug | Vehicle |
Primary outcome
Number of Subjects With Adverse Events
Time frame: 8 weeks
Subjects reporting any treatment-emergent adverse events
Eye Dryness Score (7-Day Average)
Time frame: 8 weeks
Mean change from baseline in eye dryness score (7-day average) using a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse
Corneal Fluorescein Staining
Time frame: 8 weeks
Mean change from baseline in zonal corneal fluorescein staining score in study eye using a 0- to 4-unit clinical grading scale, with 0 being better and 4 being worse
6 secondary outcomes
Ocular Discomfort Score by Visual Analog Scale
Time frame: 8 weeks
Symptom Assessment in Dry Eye (SAnDE) Score Assessment
Time frame: 8 weeks
Conjunctival Lissamine Green Staining
Time frame: 8 weeks
Conjunctival Hyperemia Grading
Time frame: 8 weeks
Tear Film Break-up Time (TBUT)
Time frame: 8 weeks
Schirmer's Test
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Dry Eye Disease
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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.
Henry Hsu, MD study director
Allysta Pharmaceutical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ALY688 0.1% and ALY688 0.4% in people with Dry Eye Disease, run by Allysta Pharmaceutical at 1 site 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 4 inclusion and 7 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 22 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With Adverse Events (time frame: 8 weeks). The study lists 3 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 22 Jun 2023.