ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease (OASIS-1)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04899518 |
Recruitment Status :
Recruiting
First Posted : May 24, 2021
Last Update Posted : June 25, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dry Eye | Drug: ALY688 Ophthalmic Solution | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 900 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | May 19, 2021 |
Estimated Primary Completion Date : | March 2022 |
Estimated Study Completion Date : | March 2022 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Vehicle Ophthalmic Solution |
Drug: ALY688 Ophthalmic Solution
Ophthalmic Solution |
Experimental: ALY688 Ophthalmic Solution Concentration 1 |
Drug: ALY688 Ophthalmic Solution
Ophthalmic Solution |
Experimental: ALY688 Ophthalmic Solution Concentration 2 |
Drug: ALY688 Ophthalmic Solution
Ophthalmic Solution |
- Corneal fluorescein staining [ Time Frame: 8 weeks ]Difference between ALY688 Ophthalmic Solution 0.4% and vehicle

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04899518
Contact: Allysta Admin | 510-560-6592 | clinicaltrial.admin@allysta.com |
United States, Washington | |
Allysta Pharmaceuticals | Recruiting |
Bellevue, Washington, United States, 98004 |
Responsible Party: | Allysta Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT04899518 |
Other Study ID Numbers: |
ALY688-301 |
First Posted: | May 24, 2021 Key Record Dates |
Last Update Posted: | June 25, 2021 |
Last Verified: | May 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Dry Eye Syndromes Keratoconjunctivitis Sicca Eye Diseases Lacrimal Apparatus Diseases Keratoconjunctivitis Conjunctivitis |
Conjunctival Diseases Keratitis Corneal Diseases Ophthalmic Solutions Pharmaceutical Solutions |