Trial Outcomes & Findings for The Effects of Cyclosporin A in a Low Humidity Environment, on the Ocular Surface (NCT NCT02199964)

Results Overview

The mean difference in corneal staining using the adjusted CCLR global staining score before and after the environmental challenge at visits baseline and Visit 3/Day 42 when patients were subjected to a 90-minute low humidity stress. Corneal fluorescein staining was graded 0-100 in 5 zones on the cornea. The scores ranged from 0 (minimum) to 500 (maximum). A higher score indicates there was greater cornea disease induced by the low humidity stress on Day 42

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

6 weeks

Results posted on

2020-02-20

Participant Flow

Recruitment process occurred at the medical clinic of the primary investigator. Recruitment began July 2014 and ended December 2015.

There were no pre-assignment details.

Participant milestones

Participant milestones
Measure	Cyclosporin 0.05% Emulsion used in the eye 4 times a day Cyclosporin 0.05% emulsion: Topical therapy for dry eye	Endura Refresh, Artificial Tears Over the Counter artificial tears used in the eye 4 times a day Endura, Refresh artificial tears: Over the counter therapy for dry eye, used 4 times a day
Overall Study STARTED	2	2
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Cyclosporin A in a Low Humidity Environment, on the Ocular Surface

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cyclosporin 0.05% Emulsion n=2 Participants used in the eye 4 times a day Cyclosporin 0.05% emulsion: Topical therapy for dry eye	Endura Refresh, Artificial Tears n=2 Participants Over the Counter artificial tears used in the eye 4 times a day Endura, Refresh artificial tears: Over the counter therapy for dry eye, used 4 times a day	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	51 years STANDARD_DEVIATION 9.9 • n=5 Participants	58 years STANDARD_DEVIATION 4.2 • n=7 Participants	54.5 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Due to loss of funding, this study was not completed and enrollment ended. Data from only 2 subjects per group was analyzed

The mean difference in corneal staining using the adjusted CCLR global staining score before and after the environmental challenge at visits baseline and Visit 3/Day 42 when patients were subjected to a 90-minute low humidity stress. Corneal fluorescein staining was graded 0-100 in 5 zones on the cornea. The scores ranged from 0 (minimum) to 500 (maximum). A higher score indicates there was greater cornea disease induced by the low humidity stress on Day 42

Outcome measures

Outcome measures
Measure	Cyclosporin 0.05% Emulsion n=2 Participants used in the eye 4 times a day Cyclosporin 0.05% emulsion: Topical therapy for dry eye	Endura Refresh, Artificial Tears n=2 Participants Over the Counter artificial tears used in the eye 4 times a day Endura, Refresh artificial tears: Over the counter therapy for dry eye, used 4 times a day
Corneal Fluorescein Staining	21.5 units on a scale Standard Deviation 13.44	29 units on a scale Standard Deviation 15.6

SECONDARY outcome

Timeframe: 6 weeks

The mean difference in subject's scoring of eye irritation symptoms using a VAS (visual analog scale) questionnaire before and after the environmental challenge after treatment at Visit 3/Day 42 when patients were subjected to a 90-minute low humidity stress. Symptoms were graded on a 4 question VAS 0-5 for each question, with scores summed for all questions for a total score that ranges from 0 (minimum) to 20 (maximum) for the pre and post challenge questionnaires. The outcome measure is the difference in the post to pre total score ranging from -20 (maximum improvement) to 20 (maximum worsening). A minus difference indicated the subject had lower irritation symptoms following the lower humidity challenge, while a positive difference indicated the subject had greater irritation following the low humidity challenge on Day 42.

Outcome measures

Outcome measures
Measure	Cyclosporin 0.05% Emulsion n=2 Participants used in the eye 4 times a day Cyclosporin 0.05% emulsion: Topical therapy for dry eye	Endura Refresh, Artificial Tears n=2 Participants Over the Counter artificial tears used in the eye 4 times a day Endura, Refresh artificial tears: Over the counter therapy for dry eye, used 4 times a day
Eye Irritation Symptoms	1.5 units on a scale Standard Deviation 2.1	1 units on a scale Standard Deviation 0

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

The number of conjunctival goblet cells measured in impression cytology at screening/baseline before and after low humidity exposure at the baseline and Day 42 visits. No (zero) subjects were analyzed because the assay was not performed and data was not collected because the study was terminated due to loss of funding.

Outcome measures

Outcome data not reported

Adverse Events

Cyclosporin 0.05% Emulsion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Endura Refresh, Artificial Tears

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, M.D.

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