Evaluation of Safety and Tolerability of Investigational Ocular Lubricants

Alcon

Status: Completed

Conditions: Dry Eye Disease

Treatments: Other: FID122505 ocular lubricant; Other: FID123300 ocular lubricant; Other: FID123301 ocular lubricant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05888519

DEP918-E001

Details and patient eligibility

About

The purpose of this study is to evaluate investigational ocular lubricants for their safety and tolerability on subjects with mild to moderate dry eye disease.

Full description

Subjects will be expected to attend a screening visit followed by 6 additional study visits. The expected duration of subject participation is approximately 3 weeks. This study will be conducted in Australia.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Sign an Informed Consent;
• Have dry eye symptoms;
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Ocular abnormalities;
• Active ocular infection or inflammation not associated with dry eye;
• History of ocular or intraocular surgery;
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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47 participants in 3 patient groups

FID123300/FID123301/FID122505

Other group

Description:

FID123300 ocular lubricant in Period 1, followed by FID12330 ocular lubricant in Period 2, followed by FID122505 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.

Treatment:

Other: FID122505 ocular lubricant

Other: FID123300 ocular lubricant

Other: FID123301 ocular lubricant

FID123301/FID122505/FID123300

Other group

Description:

FID123301 ocular lubricant in Period 1, followed by FID122505 ocular lubricant in Period 2, followed by FID123300 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.

Treatment:

Other: FID122505 ocular lubricant

Other: FID123300 ocular lubricant

Other: FID123301 ocular lubricant

FID122505/FID123300/FID123301

Other group

Description:

FID122505 ocular lubricant in Period 1, followed by FID123300 ocular lubricant in Period 2, followed by FID123301 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.

Treatment:

Other: FID122505 ocular lubricant

Other: FID123300 ocular lubricant

Other: FID123301 ocular lubricant