Trial Outcomes & Findings for Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome (NCT NCT01382225)

Results Overview

The investigator instilled an ophthalmic dye on the eye and rated staining in three areas (cornea, nasal, and temporal conjunctiva). Staining was rated on a 5-point scale from 0 to 4 (0=0% to 4=\>45%). The LGS Total Score (0-12) is the sum of the three individual ratings. A more negative change indicates a greater amount of improvement.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1936 participants

Primary outcome timeframe

Baseline, Day 7

Results posted on

2013-07-08

Participant Flow

Subjects were recruited from 56 investigative sites in the United States.

Of the 1936 subjects enrolled, 268 did not qualify for vehicle run-in and were exited as screen failures. Of the 1668 subjects receiving vehicle run-in, 214 did not qualify for randomization and were exited as screen failures. This reporting group includes the 1454 subjects randomized to receive treatment at Baseline Visit (Day 0).

Participant milestones

Participant milestones
Measure	Sodium Hyaluronate Run-in, followed by Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days	Vehicle Run-in, followed by Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Overall Study STARTED	725	729
Overall Study COMPLETED	711	722
Overall Study NOT COMPLETED	14	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Sodium Hyaluronate Run-in, followed by Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days	Vehicle Run-in, followed by Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Overall Study Adverse Event	3	2
Overall Study Protocol Violation	2	1
Overall Study Subject Withdrew Consent	5	2
Overall Study Other	4	2

Baseline Characteristics

Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sodium Hyaluronate n=723 Participants Run-in, followed by Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days	Vehicle n=727 Participants Run-in, followed by Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days	Total n=1450 Participants Total of all reporting groups
Age, Customized 18-64 years	402 participants n=5 Participants	392 participants n=7 Participants	794 participants n=5 Participants
Age, Customized ≥65 years	321 participants n=5 Participants	335 participants n=7 Participants	656 participants n=5 Participants
Sex: Female, Male Female	590 Participants n=5 Participants	594 Participants n=7 Participants	1184 Participants n=5 Participants
Sex: Female, Male Male	133 Participants n=5 Participants	133 Participants n=7 Participants	266 Participants n=5 Participants
Region of Enrollment United States	723 participants n=5 Participants	727 participants n=7 Participants	1450 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Day 7

Population: Modified Intent-to-Treat (mITT): The set of all randomized subjects who received at least one administration of the allocated product, had baseline efficacy measurement, had at least 1 post-baseline measurement and received the correct formulation of the lissamine green solution.

The investigator instilled an ophthalmic dye on the eye and rated staining in three areas (cornea, nasal, and temporal conjunctiva). Staining was rated on a 5-point scale from 0 to 4 (0=0% to 4=\>45%). The LGS Total Score (0-12) is the sum of the three individual ratings. A more negative change indicates a greater amount of improvement.