A Study of the Drugs AGN-242428 and AGN-231868 in Participants With Dry Eye Disease

Inclusion Criteria

• •Stage 1 \& Stage 2:
• •Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study.
• •Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study.
• •Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
• •Stage 1:
• •Both of the following signs of DED in at least 1 eye at Screening and Baseline visits (the same eye does not need to qualify at both visits):
• •Total corneal fluorescein staining score ≥ 2 and ≤ 9 based on the NEI grading scale, with no score \> 2 in any 1 region;
• •Schirmer test with topical anesthesia score ≥ 1 and ≤ 10 mm/5 min.
• •Stage 2:
• •ALL of the following in at least 1 eye at both the Screening and Baseline visits and the same eye must qualify at both Screening and Baseline visits:
• •Corneal fluorescein staining score ≥ 2 in at least 1 eye region and a total corneal fluorescein staining score of ≥ 4 and ≤ 12 based on NEI grading scale;
• •Schirmer test with topical anesthesia score ≥ 2 and ≤ 10 mm/5 min;
• •Mean TBUT of ≥ 2 and ≤ 10 seconds.
• •Stage 1:
• •\- Symptoms of DED at both the Screening and Baseline visits as defined by an OSDI total score of ≥ 13 with ≤ 3 responses of "not applicable (NA)."
• •Stage 2:
• •Symptoms of DED at both the Screening and Baseline visits as defined by both:
• •OSDI score of ≥ 23 with ≤ 3 responses of "not applicable (NA)" in at least 1 eye;
• •Eye Dryness Score (assessed using the Visual Analog Scale \[VAS\] Symptom Items score ≥ 30).