Trial Outcomes & Findings for Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort (NCT NCT04163328)

NCT ID: NCT04163328

Last Updated: 2025-03-06

Results Overview

The CLDEQ-8 is a contact lens specific symptoms survey, range = 0-37 with 37 being most symptomatic.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 31 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2025-03-06

Participant Flow

n=31 patients consented and examined n=12 patients randomized/completed (18 screen fails, one discontinued prior to randomization) The study was terminated by the sponsor prior to completing recruitment due to a variety of events including haulted COVID recruitment and manufacturing of the active and placebo formulations. The shelf-life of the initial batches of active and control/placebo expired.

Participant milestones

Measure	HydroEye® Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). HydroEye®: This is an omega-3 fatty acids supplement. n=31 patients completed consent and were examined n=12 patients randomized/completed (18 screen fails, one discontinued) n=6 active (A)	Placebo Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). HydroEye®: This is an omega-3 fatty acids supplement. n=31 patients completed consent and were examined n=12 patients randomized/completed (18 screen fails, one discontinued) n=6 placebo (P)
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	HydroEye® n=6 Participants Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). HydroEye®: This is an omega-3 fatty acids supplement. n=31 patients completed consent and were examined n=12 patients randomized/completed (18 screen fails, one discontinued) n=6 active (A)	Placebo n=6 Participants Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). HydroEye®: This is an omega-3 fatty acids supplement. n=31 patients completed consent and were examined n=12 patients randomized/completed (18 screen fails, one discontinued) n=6 placebo (P)	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=6 Participants	6 Participants n=6 Participants	12 Participants n=12 Participants
Age, Categorical >=65 years	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants
Sex: Female, Male Female	6 Participants n=6 Participants	5 Participants n=6 Participants	11 Participants n=12 Participants
Sex: Female, Male Male	0 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=12 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	6 participants n=6 Participants	6 participants n=6 Participants	12 participants n=12 Participants
CLDEQ survey	23.7 units on a scale STANDARD_DEVIATION 4.2 • n=6 Participants	23.5 units on a scale STANDARD_DEVIATION 6.2 • n=6 Participants	23.6 units on a scale STANDARD_DEVIATION 5.0 • n=12 Participants
Number of participants with a non-zero Neuropathic Pain Symptom Inventory (NPSI) Score	1 Participants n=6 Participants	1 Participants n=6 Participants	2 Participants n=12 Participants
Tear Film Break-up time	14.8 seconds STANDARD_DEVIATION 11.2 • n=6 Participants	13.6 seconds STANDARD_DEVIATION 6.3 • n=6 Participants	14.2 seconds STANDARD_DEVIATION 8.7 • n=12 Participants
Schirmer I score	19.8 mm STANDARD_DEVIATION 12.5 • n=6 Participants	24.5 mm STANDARD_DEVIATION 10.8 • n=6 Participants	22.2 mm STANDARD_DEVIATION 13.0 • n=12 Participants
Corneal Staining	3.2 points STANDARD_DEVIATION 2.1 • n=6 Participants	2.8 points STANDARD_DEVIATION 1.2 • n=6 Participants	3.0 points STANDARD_DEVIATION 2.3 • n=12 Participants
Conjunctival staining	2.2 points STANDARD_DEVIATION 1.8 • n=6 Participants	2.2 points STANDARD_DEVIATION 1.2 • n=6 Participants	2.2 points STANDARD_DEVIATION 1.6 • n=12 Participants
SPEED survey	10.2 points STANDARD_DEVIATION 2.9 • n=6 Participants	7.5 points STANDARD_DEVIATION 4.0 • n=6 Participants	8.8 points STANDARD_DEVIATION 2.9 • n=12 Participants

PRIMARY outcome

Timeframe: 6 months

The CLDEQ-8 is a contact lens specific symptoms survey, range = 0-37 with 37 being most symptomatic.

Outcome measures

Measure	HydroEye® n=6 Participants Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). HydroEye®: This is an omega-3 fatty acids supplement. n=31 patients completed consent and were examined n=12 patients randomized/completed (18 screen fails, one discontinued) n=6 active (A)	Placebo n=6 Participants Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). HydroEye®: This is an omega-3 fatty acids supplement. n=31 patients completed consent and were examined n=12 patients randomized/completed (18 screen fails, one discontinued) n=6 placebo (P)
Average Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score	15.0 score on a scale Standard Deviation 2.6	11.3 score on a scale Standard Deviation 6.4

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: This lab test was not performed. There was insufficient tears collected to do the analysis due to the sponsor cancelling the study before adequate enough samples could be collected. Due to study termination and the prohibitive costs of performing the laboratory testing, samples collected from 12 participants, approximately 1/4 the number needed to justify processing the samples based on an a priori power analysis, were never assayed and will never be assayed.

If there is an adequate number of tear samples collected, LTB4 values will be tested with a biochemical assay to estimate eye surface inflammation. Pooled tears may be needed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

The SPEED is a dry eye specific symptoms survey, we are using the Rasch validated version; range = 0-28 with 28 being most symptomatic.

Outcome measures

Measure	HydroEye® n=6 Participants Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). HydroEye®: This is an omega-3 fatty acids supplement. n=31 patients completed consent and were examined n=12 patients randomized/completed (18 screen fails, one discontinued) n=6 active (A)	Placebo n=6 Participants Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). HydroEye®: This is an omega-3 fatty acids supplement. n=31 patients completed consent and were examined n=12 patients randomized/completed (18 screen fails, one discontinued) n=6 placebo (P)
Average Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score	4.8 score on a scale Standard Deviation 1.7	4.7 score on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: 6 months

NPSI is a pain specific symptoms survey; range = 0-100 with 100 being most symptomatic. The survey is used to assess serious and chronic pain; therefore the number of subjects with non-zero NPSI values was expected to be minimal, and change to non-zero values was measured in treatment and placebo arms.

Outcome measures

Measure	HydroEye® n=6 Participants Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). HydroEye®: This is an omega-3 fatty acids supplement. n=31 patients completed consent and were examined n=12 patients randomized/completed (18 screen fails, one discontinued) n=6 active (A)	Placebo n=6 Participants Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). HydroEye®: This is an omega-3 fatty acids supplement. n=31 patients completed consent and were examined n=12 patients randomized/completed (18 screen fails, one discontinued) n=6 placebo (P)
Number of Participants With a Non-zero Neuropathic Pain Symptom Inventory (NPSI) Questionnaire Score	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months

This is a measure of tear stability with higher values being better (seconds).

Outcome measures

Measure	HydroEye® n=6 Participants Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). HydroEye®: This is an omega-3 fatty acids supplement. n=31 patients completed consent and were examined n=12 patients randomized/completed (18 screen fails, one discontinued) n=6 active (A)	Placebo n=6 Participants Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). HydroEye®: This is an omega-3 fatty acids supplement. n=31 patients completed consent and were examined n=12 patients randomized/completed (18 screen fails, one discontinued) n=6 placebo (P)
Average Tear Breakup Time in Seconds	16.0 seconds Standard Deviation 15.6	8.3 seconds Standard Deviation 2.7

SECONDARY outcome

Timeframe: 6 months

This is a measure of tear volume with higher values being better (0 mm - 35 mm).

Outcome measures

Measure	HydroEye® n=6 Participants Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). HydroEye®: This is an omega-3 fatty acids supplement. n=31 patients completed consent and were examined n=12 patients randomized/completed (18 screen fails, one discontinued) n=6 active (A)	Placebo n=6 Participants Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). HydroEye®: This is an omega-3 fatty acids supplement. n=31 patients completed consent and were examined n=12 patients randomized/completed (18 screen fails, one discontinued) n=6 placebo (P)
Average Schirmer I Test in mm	22.8 mm Standard Deviation 13.0	21.7 mm Standard Deviation 14.6

SECONDARY outcome

Timeframe: 6 months

This is a measure of eye irritation with higher values being worse (NEI scale with range of 0 to 15) with higher scores being worse.

Outcome measures

Measure	HydroEye® n=6 Participants Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). HydroEye®: This is an omega-3 fatty acids supplement. n=31 patients completed consent and were examined n=12 patients randomized/completed (18 screen fails, one discontinued) n=6 active (A)	Placebo n=6 Participants Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). HydroEye®: This is an omega-3 fatty acids supplement. n=31 patients completed consent and were examined n=12 patients randomized/completed (18 screen fails, one discontinued) n=6 placebo (P)
Average Corneal Staining Score	3.3 units on a scale Standard Deviation 2.7	3.3 units on a scale Standard Deviation 3.9

SECONDARY outcome

Timeframe: 6 months

This is a measure of eye irritation with higher values being worse (NEI scale with range of 0 to 18).

Outcome measures

Measure	HydroEye® n=6 Participants Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). HydroEye®: This is an omega-3 fatty acids supplement. n=31 patients completed consent and were examined n=12 patients randomized/completed (18 screen fails, one discontinued) n=6 active (A)	Placebo n=6 Participants Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). HydroEye®: This is an omega-3 fatty acids supplement. n=31 patients completed consent and were examined n=12 patients randomized/completed (18 screen fails, one discontinued) n=6 placebo (P)
Average Conjunctival Staining Score	1.3 units on a scale Standard Deviation 2.0	2.5 units on a scale Standard Deviation 1.2

Adverse Events

HydroEye®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr. Kelly K. Nichols

UAB

Phone: 205-975-9935

Email: nicholsk@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place