Dry EyePhase 2/3OASIS-1NCT04899518
ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease
A Phase 2/3 study testing ALY688 Ophthalmic Solution in people with Dry Eye, run by Allysta Pharmaceutical at 1 site in United States.
Trial summary
Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution 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
- What is being tested?
- ALY688 Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 922 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2021to 14 Mar 2023
- Phase
- Phase 2/3
- 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
- Dry eye disease for > 3 months meeting specific sign and symptom criteria
- Best corrected 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 infection 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 2b/3, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease (OASIS-1)
Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects with Dry Eye Disease
Read the detailed description
Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects with Dry Eye Disease
- Conditions
- Dry Eye
- Being tested
- ALY688 Ophthalmic Solution
- 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 Ophthalmic SolutionDrug
Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| Vehicle Ophthalmic Solution | Placebo comparator | Not described Receives: Drug: ALY688 Ophthalmic Solution |
| ALY688 Ophthalmic Solution Concentration 1 | Experimental | Not described Receives: Drug: ALY688 Ophthalmic Solution |
| ALY688 Ophthalmic Solution Concentration 2 | Experimental | Not described Receives: Drug: ALY688 Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal fluorescein staining
Difference between ALY688 Ophthalmic Solution 0.4% and vehicle
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 posted24 May 2021
- Study start19 May 2021
- Primary completion14 Mar 2023
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 922 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allysta Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899518
- Sponsor's protocol ID
- ALY688-301
- Acronym
- OASIS-1
- Status last verified
- Mar 2023
- First submitted
- 19 May 2021
- Last updated
- 16 Mar 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 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b/3, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease (OASIS-1)
- ClinicalTrials.gov ID
- NCT04899518
- Acronym / sponsor ID
- OASIS-1 / ALY688-301
- Conditions
- Dry Eye
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 922 participants (actual)
- Lead sponsor
- Allysta PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 19 May 2021 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 24 May 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.
Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects with Dry Eye Disease
Detailed description
Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects with 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Vehicle Ophthalmic Solution | Placebo comparator | Drug: ALY688 Ophthalmic Solution |
| ALY688 Ophthalmic Solution Concentration 1 | Experimental | Drug: ALY688 Ophthalmic Solution |
| ALY688 Ophthalmic Solution Concentration 2 | Experimental | Drug: ALY688 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 corrected 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 infection 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 Ophthalmic SolutionOphthalmic Solution | Drug | ALY688 Ophthalmic Solution Concentration 1, ALY688 Ophthalmic Solution Concentration 2, Vehicle Ophthalmic Solution |
Primary outcome
Corneal fluorescein staining
Time frame: 8 weeks
Difference between ALY688 Ophthalmic Solution 0.4% and vehicle
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 16 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ALY688 Ophthalmic Solution in people with Dry Eye, 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 16 Mar 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Corneal fluorescein staining (time frame: 8 weeks). 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 16 Mar 2023.