Trial Outcomes & Findings for Study to Evaluate a Contact Lens Lubricating and Rewetting Drop (NCT NCT01267656)

Results Overview

Slit lamp findings for epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded 0 to 4, with 0 = none to 4 = severe. The outcome measure is any finding \> grade 2, across abnormalities.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

168 participants

Primary outcome timeframe

At 1 week follow up

Results posted on

2020-09-30

Participant Flow

There were 168 participants enrolled and 166 participants treated. The study was a cross-over study, so the 166 participants received both treatment groups.

Participant milestones

Participant milestones
Measure	Lubricating and Rewetting Drops Then AMO Blink Contacts Lubric Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week. Lubricating and Rewetting Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week. AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week AMO Blink Contacts Lubricant Eye Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.	AMO Blink Contacts Lubricant Eye Drops Then Lubricating and Re AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week AMO Blink Contacts Lubricant Eye Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week. Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week. Lubricating and Rewetting Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.
Overall Study STARTED	83	83
Overall Study COMPLETED	82	82
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate a Contact Lens Lubricating and Rewetting Drop

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=166 Participants The study was a cross-over study, so the 166 treated participants received both treatment groups.
Age, Continuous	33.4 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	120 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 1 week follow up

Population: There were 330 eyes evaluable for slit lamp findings in each group.

Slit lamp findings for epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded 0 to 4, with 0 = none to 4 = severe. The outcome measure is any finding \> grade 2, across abnormalities.

Outcome measures

Outcome measures
Measure	Lubricating and Rewetting Drops n=330 eyes Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week. Lubricating and Rewetting Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.	AMO Blink Contacts Lubricant Eye Drops n=330 eyes AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week AMO Blink Contacts Lubricant Eye Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.
Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2.	1 eyes	0 eyes

Adverse Events

Lubricating and Rewetting Drops

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AMO Blink Contacts Lubricant Eye Drops

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Bausch Health

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Contact sponsor directly for details.
Publication restrictions are in place

Restriction type: OTHER