Evaluation of Safety and Tolerability of Investigational Ocular Lubricants

Sponsor

Alcon Research (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05888519

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

13.3

Patients Per Site

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Other: FID123300 ocular lubricant Other: FID123301 ocular lubricant Other: FID122505 ocular lubricant	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of Safety and Tolerability of Investigational Ocular Lubricants

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: FID123300/FID123301/FID122505 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.	Other: FID123300 ocular lubricant Investigational ocular lubricant Other: FID123301 ocular lubricant Investigational ocular lubricant Other: FID122505 ocular lubricant Comparator ocular lubricant
Other: FID123301/FID122505/FID123300 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.	Other: FID123300 ocular lubricant Investigational ocular lubricant Other: FID123301 ocular lubricant Investigational ocular lubricant Other: FID122505 ocular lubricant Comparator ocular lubricant
Other: FID122505/FID123300/FID123301 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.	Other: FID123300 ocular lubricant Investigational ocular lubricant Other: FID123301 ocular lubricant Investigational ocular lubricant Other: FID122505 ocular lubricant Comparator ocular lubricant

Arm

Intervention/Treatment

Other: FID123300/FID123301/FID122505

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.

Other: FID123300 ocular lubricant