Trial Outcomes & Findings for Evaluation of Delefilcon A Contact Lenses (NCT NCT06884202)
NCT ID: NCT06884202
Last Updated: 2026-08-21
Results Overview
Lens movement was evaluated by the investigator using a slit lamp with the eye in primary gaze (looking straight ahead). Subject was asked to blink after which the investigator pushed up the lower lid margin to evaluate lens movement. Lens movement was graded on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable). A grade of Acceptably Tight, Optimal Fit, or Acceptably Loose is considered to be acceptable lens fit.
COMPLETED
NA
267 participants
Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period
2026-08-21
Participant Flow
Of the 267 enrolled, 15 participants were screen failures. This reporting group includes all participants exposed to any study lenses evaluated in this study (252).
Unit of analysis: eyes
Participant milestones
| Measure |
LID023681, Then LID006961
Delefilcon A contact lenses with different base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with standard base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods.
|
LID006961, Then LID023681
Delefilcon A contact lenses with standard base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with different base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods.
|
|---|---|---|
|
Period 1 (approximately 6 (+2) hours)
STARTED
|
129 258
|
123 246
|
|
Period 1 (approximately 6 (+2) hours)
COMPLETED
|
129 258
|
122 244
|
|
Period 1 (approximately 6 (+2) hours)
NOT COMPLETED
|
0 0
|
1 2
|
|
Washout Period (approximately 1-2 days)
STARTED
|
129 258
|
122 244
|
|
Washout Period (approximately 1-2 days)
COMPLETED
|
129 258
|
122 244
|
|
Washout Period (approximately 1-2 days)
NOT COMPLETED
|
0 0
|
0 0
|
|
Period 2 (approximately 6 (+2)
STARTED
|
129 258
|
122 244
|
|
Period 2 (approximately 6 (+2)
COMPLETED
|
128 256
|
122 244
|
|
Period 2 (approximately 6 (+2)
NOT COMPLETED
|
1 2
|
0 0
|
Reasons for withdrawal
| Measure |
LID023681, Then LID006961
Delefilcon A contact lenses with different base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with standard base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods.
|
LID006961, Then LID023681
Delefilcon A contact lenses with standard base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with different base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods.
|
|---|---|---|
|
Period 1 (approximately 6 (+2) hours)
Administrative reasons unrelated to safety
|
0
|
1
|
|
Period 2 (approximately 6 (+2)
Adverse Event
|
1
|
0
|
Baseline Characteristics
Evaluation of Delefilcon A Contact Lenses
Baseline characteristics by cohort
| Measure |
LID023681, Then LID006961
n=129 Participants
Delefilcon A contact lenses with different base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with standard base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods.
|
LID006961, Then LID023681
n=123 Participants
Delefilcon A contact lenses with standard base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with different base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods.
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.2 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
32.6 years
STANDARD_DEVIATION 9.1 • n=109 Participants
|
32.4 years
STANDARD_DEVIATION 9.3 • n=133 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
81 Participants
n=109 Participants
|
170 Participants
n=133 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
42 Participants
n=109 Participants
|
82 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
White
|
71 Participants
n=5 Participants
|
66 Participants
n=109 Participants
|
137 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=5 Participants
|
4 Participants
n=109 Participants
|
11 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
Asian
|
42 Participants
n=5 Participants
|
48 Participants
n=109 Participants
|
90 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
1 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
3 Participants
n=109 Participants
|
8 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
4 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
5 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
12 Participants
n=5 Participants
|
8 Participants
n=109 Participants
|
20 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
117 Participants
n=5 Participants
|
115 Participants
n=109 Participants
|
232 Participants
n=133 Participants
|
PRIMARY outcome
Timeframe: Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover periodPopulation: Full Analysis Set (FAS): all randomized subjects exposed to any study lens.
Lens movement was evaluated by the investigator using a slit lamp with the eye in primary gaze (looking straight ahead). Subject was asked to blink after which the investigator pushed up the lower lid margin to evaluate lens movement. Lens movement was graded on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable). A grade of Acceptably Tight, Optimal Fit, or Acceptably Loose is considered to be acceptable lens fit.
Outcome measures
| Measure |
LID023681
n=502 eyes
Delefilcon A contact lenses with different base curves and diameters worn in Period 1 or 2 as randomized in both eyes for 6 (+2) hours.
|
LID006961
n=504 eyes
Delefilcon A contact lenses with standard base curves and diameters worn in Period 1 or 2 as randomized in both eyes for 6 (+2) hours.
|
|---|---|---|
|
Proportion of Lenses Graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at Dispense in Lens Movement (Overall Lens Fit) at Primary Gaze
|
1.0 proportion of lenses
|
1.0 proportion of lenses
|
PRIMARY outcome
Timeframe: Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover periodPopulation: Full Analysis Set (FAS): all randomized subjects exposed to any study lens.
Lens movement was evaluated by the investigator using a slit lamp with the eye in peripheral gaze (upward gaze, downward gaze, looking to the left, and looking to the right). Lens movement was assessed for each gaze on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable). The overall lens fit grade was based on the worst-case scenario among the different gazes. A grade of Acceptably Tight, Optimal Fit, or Acceptably Loose is considered to be acceptable lens fit.
Outcome measures
| Measure |
LID023681
n=502 eyes
Delefilcon A contact lenses with different base curves and diameters worn in Period 1 or 2 as randomized in both eyes for 6 (+2) hours.
|
LID006961
n=504 eyes
Delefilcon A contact lenses with standard base curves and diameters worn in Period 1 or 2 as randomized in both eyes for 6 (+2) hours.
|
|---|---|---|
|
Proportion of Lenses Graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at Dispense in Lens Movement (Overall Lens Fit) at Peripheral Gazes
|
1.0 proportion of lenses
|
1.0 proportion of lenses
|
PRIMARY outcome
Timeframe: Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover periodPopulation: Full Analysis Set (FAS): all randomized subjects exposed to any study lens.
Lens position was evaluated by the investigator using a slit lamp with the eye in primary position (relaxed, looking straight ahead). Lens position was graded on a 3-point scale as follows: 0 = Optimal centration; 1 = Acceptable decentration; 2 = Unacceptable decentration. A grade of Optimal Centration or Acceptable Decentration is considered to be acceptable centration.
Outcome measures
| Measure |
LID023681
n=502 eyes
Delefilcon A contact lenses with different base curves and diameters worn in Period 1 or 2 as randomized in both eyes for 6 (+2) hours.
|
LID006961
n=504 eyes
Delefilcon A contact lenses with standard base curves and diameters worn in Period 1 or 2 as randomized in both eyes for 6 (+2) hours.
|
|---|---|---|
|
Proportion of Lenses Graded as Optimal Lens Centration or Acceptable Decentration at Dispense in Lens Position (Centration)
|
1.0 proportion of lenses
|
1.0 proportion of lenses
|
PRIMARY outcome
Timeframe: Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover periodPopulation: Full Analysis Set (FAS): all randomized subjects exposed to any study lens.
Lens movement was evaluated by the investigator using a slit lamp with the eye in primary gaze (looking straight ahead). Subject was asked to blink after which the investigator pushed up the lower lid margin to evaluate lens movement. Lens movement was graded on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable). A grade of Acceptably Tight, Optimal Fit, or Acceptably Loose is considered to be acceptable lens fit.
Outcome measures
| Measure |
LID023681
n=502 eyes
Delefilcon A contact lenses with different base curves and diameters worn in Period 1 or 2 as randomized in both eyes for 6 (+2) hours.
|
LID006961
n=504 eyes
Delefilcon A contact lenses with standard base curves and diameters worn in Period 1 or 2 as randomized in both eyes for 6 (+2) hours.
|
|---|---|---|
|
Proportion of Lenses Graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at 6 Hour Follow-up in Lens Movement (Overall Fit) at Primary Gaze
|
1.0 proportion of lenses
|
1.0 proportion of lenses
|
PRIMARY outcome
Timeframe: Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover periodPopulation: Full Analysis Set (FAS): all randomized subjects exposed to any study lens.
Lens movement was evaluated by the investigator using a slit lamp with the eye in peripheral gaze (upward gaze, downward gaze, looking to the left, and looking to the right). Lens movement was assessed for each gaze on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable). The overall lens fit grade was based on the worst-case scenario among the different gazes. A grade of Acceptably Tight, Optimal Fit, or Acceptably Loose is considered to be acceptable lens fit.
Outcome measures
| Measure |
LID023681
n=502 eyes
Delefilcon A contact lenses with different base curves and diameters worn in Period 1 or 2 as randomized in both eyes for 6 (+2) hours.
|
LID006961
n=504 eyes
Delefilcon A contact lenses with standard base curves and diameters worn in Period 1 or 2 as randomized in both eyes for 6 (+2) hours.
|
|---|---|---|
|
Proportion of Lenses Graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at 6 Hour Follow-up in Lens Movement (Overall Fit) at Peripheral Gazes
|
1.0 proportion of lenses
|
1.0 proportion of lenses
|
PRIMARY outcome
Timeframe: Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover periodPopulation: Full Analysis Set (FAS): all randomized subjects exposed to any study lens.
Lens position was evaluated by the investigator using a slit lamp with the eye in primary position (relaxed, looking straight ahead). Lens position was graded on a 3-point scale as follows: 0 = Optimal centration; 1 = Acceptable decentration; 2 = Unacceptable decentration. A grade of Optimal Centration or Acceptable Decentration is considered to be acceptable centration.
Outcome measures
| Measure |
LID023681
n=502 eyes
Delefilcon A contact lenses with different base curves and diameters worn in Period 1 or 2 as randomized in both eyes for 6 (+2) hours.
|
LID006961
n=504 eyes
Delefilcon A contact lenses with standard base curves and diameters worn in Period 1 or 2 as randomized in both eyes for 6 (+2) hours.
|
|---|---|---|
|
Proportion of Lenses Graded as Optimal Lens Centration or Acceptable Decentration at 6 Hour Follow-up in Lens Position (Centration)
|
1.00 proportion of lenses
|
1.00 proportion of lenses
|
Adverse Events
Pretreatment
LID023681 Ocular
LID023681 Nonocular
LID006961 Ocular
LID006961 Nonocular
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director, Clinical Project Management, Vision Care
Alcon Research, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER