Phase 2 N=138 Randomized Quadruple-blind Treatment

Phase 1/2a Safety and Efficacy of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease

Dry Eye Disease

Bottom Line

View on ClinicalTrials.gov: NCT04201574 ↗

Enrolled (actual)

138

Serious AEs

0.7%

Results posted

Jun 2023

Primary outcome: Primary: Number of Subjects With Adverse Events — 13; 15; 10 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ALY688 0.1% (Drug); ALY688 0.4% (Drug); Vehicle (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Allysta Pharmaceutical
Primary completion: Sep 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Adverse Events	13; 15; 10	—
PRIMARY Eye Dryness Score (7-Day Average)	-6.48; -5.66; -11.14	—
PRIMARY Corneal Fluorescein Staining	-0.33; -0.37; -0.51; -0.31; -0.21; -0.36	—
SECONDARY Ocular Discomfort Score by Visual Analog Scale	-8.19; -4.47; -8.62	—
SECONDARY Symptom Assessment in Dry Eye (SAnDE) Score Assessment	-13.76; -6.76; -15.48	—
SECONDARY Conjunctival Lissamine Green Staining	0.12; -0.13; -0.18; -0.04; -0.25; -0.31	—
SECONDARY Conjunctival Hyperemia Grading	-0.17; -0.15; -0.13; -0.20; -0.13; -0.24	—
SECONDARY Tear Film Break-up Time (TBUT)	0.29; 0.13; 0.18	—
SECONDARY Schirmer's Test	1.64; 1.92; 2.50	—

Summary

Clinical Trial Evaluating the Safety and Tolerability of ALY688 in Subjects with Dry Eye Disease

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04201574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.