Trial Outcomes & Findings for Effects of Dry Eye Treatments on the Ocular Surface (NCT NCT01797822)

Results Overview

Subjects will be treated with preservative-free artificial tears for 2 weeks then exposed to a low humidity environment for 90 minutes, then treated with preservative-free dexamethasone 0.1% for 2 weeks and exposed to a low humidity environment again. The change in corneal fluorescein staining before and after the low humidity exposure was measured after each treatment. Fluorescein staining was graded using the CCLR scale (0-100) in 5 zones on the cornea for a maximum score of 500 (range 0-500). A lower change in staining indicates less severe disease in response to the low humidity stress. Negative number indicates staining after exposure was lower than pre.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

Two weeks after treatment and exposure to a low humidity environment

Results posted on

2020-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Artificial Tears First, Then Dexamethasone 0.01% Artificial tears four times a day for two weeks in both eyes, then Dexamethasone 0.01% ophthalmic solution four times a day for two weeks in both eyes
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Dry Eye Treatments on the Ocular Surface

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexamethasone, Artificial Tears n=20 Participants Dexamethasone 0.01% ophthalmic solution four times a day for two weeks in both eyes Artificial tears four times a day for two weeks in both eyes dexamethasone, artificial tears
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	54.25 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Two weeks after treatment and exposure to a low humidity environment

Population: difference (change) in fluorescein staining pre- and post-exposure to low humidity stress

Subjects will be treated with preservative-free artificial tears for 2 weeks then exposed to a low humidity environment for 90 minutes, then treated with preservative-free dexamethasone 0.1% for 2 weeks and exposed to a low humidity environment again. The change in corneal fluorescein staining before and after the low humidity exposure was measured after each treatment. Fluorescein staining was graded using the CCLR scale (0-100) in 5 zones on the cornea for a maximum score of 500 (range 0-500). A lower change in staining indicates less severe disease in response to the low humidity stress. Negative number indicates staining after exposure was lower than pre.

Outcome measures

Outcome measures
Measure	Artificial Tears n=20 Participants Artificial tears four times a day for two weeks in both eyes/Artificial tears	Dexamethasone n=20 Participants Dexamethasone 4 times per day for 2 weeks in both eyes/Dexamethasone
Changes in Corneal Fluorescein Staining	22.18 units on a scale Standard Deviation 22.03	-3.35 units on a scale Standard Deviation 18.83

Adverse Events

Dexamethasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Artificial Tear

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

Stephen Pflugfelder

Baylor College of Medicine

Phone: 713-798-6100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place