A Phase 3b Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes
Overview
- Phase
- Phase 3
- Intervention
- 0.003% AR-15512 ophthalmic solution
- Conditions
- Dry Eye Disease
- Sponsor
- Alcon Research
- Enrollment
- 55
- Locations
- 6
- Primary Endpoint
- Percentage of Subjects With Ocular Treatment-Emergent Adverse Events Attributed to Study Intervention
- Status
- Completed
- Last Updated
- last month
Overview
Brief Summary
The purpose of this study is to evaluate the percentage of ocular adverse events reported in subjects with dry eye disease (DED) between the intervention arm (0.003% AR-15512) and control arm (REFRESH® Classic).
Detailed Description
Subjects will be randomized to one of four sequences of 0.003% AR-15512 ophthalmic solution instillation variations which will be administered after administration of control (REFRESH® Classic). This is a 1-visit study (Screening, Enrollment, Assessments).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Corrected Visual Acuity (Snellen) 20/200 or better in both eyes;
- •Good general and ocular health, as determined by the Investigator using medical history, ophthalmic examination and history;
- •Capable of giving signed informed consent.
- •Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- •Current evidence of other clinically significant ophthalmic disease other than dry eye;
- •History of ocular surgery within 1 year of the Study Visit;
- •Use of any topical ocular anti-inflammatory medications (for example, Restasis®, Cequa™, Vevye™, Xiidra®), other prescription ophthalmic product for dry eyes, topical ocular corticosteroid, or non-steroidal-anti-inflammatory agents within 30 days of the Study Visit;
- •Positive pregnancy test or currently breastfeeding.
- •Other protocol-defined exclusion criteria may apply.
Arms & Interventions
Sequence 1
One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-RT, then 512-COLD, followed by 512-RT-EC, and finally 512-COLD-EC. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
Intervention: 0.003% AR-15512 ophthalmic solution
Sequence 1
One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-RT, then 512-COLD, followed by 512-RT-EC, and finally 512-COLD-EC. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
Intervention: Artificial tears
Sequence 2
One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-RT-EC, then 512-RT, followed by 512-COLD-EC, and finally 512-COLD. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
Intervention: 0.003% AR-15512 ophthalmic solution
Sequence 2
One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-RT-EC, then 512-RT, followed by 512-COLD-EC, and finally 512-COLD. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
Intervention: Artificial tears
Sequence 3
One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-COLD, then 512-COLD-EC, followed by 512-RT, and finally 512-RT-EC. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
Intervention: 0.003% AR-15512 ophthalmic solution
Sequence 3
One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-COLD, then 512-COLD-EC, followed by 512-RT, and finally 512-RT-EC. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
Intervention: Artificial tears
Sequence 4
One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-COLD-EC, then 512-RT-EC, followed by 512-COLD, and finally 512-RT. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
Intervention: 0.003% AR-15512 ophthalmic solution
Sequence 4
One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-COLD-EC, then 512-RT-EC, followed by 512-COLD, and finally 512-RT. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
Intervention: Artificial tears
Outcomes
Primary Outcomes
Percentage of Subjects With Ocular Treatment-Emergent Adverse Events Attributed to Study Intervention
Time Frame: Up to Day 1 post drop instillation
Treatment-emergent adverse events (TEAEs) were defined as any event that occurred or worsened on or after the day that study intervention was initiated. No hypothesis testing was prespecified for this endpoint.