Trial Outcomes & Findings for The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses (NCT NCT05020990)

NCT ID: NCT05020990

Last Updated: 2023-12-20

Results Overview

Subjective handling rating on lens removal was measured on a scale of 0-100 where 0=Unmanageable and 100=Excellent removal.

Recruitment status

COMPLETED

Study phase

Target enrollment

55 participants

Primary outcome timeframe

One week

Results posted on

2023-12-20

Participant Flow

A total of 55 participants were dispensed study lenses, and 54 completed the study. Five participants discontinued the study prior to dispensing and were therefore not included in either the enrollment count or data analysis population. Nine participants were ineligible.

Five participants were initially ineligible, but were re-enrolled following a protocol amendment that expanded the age range and allowed the use of an increased range of lens axes for Lens A.

Participant milestones

Participant milestones
Measure	Lens A (Delefilcon A), Then Lens B (Stenfilcon A) Participants wore Lens A for one week, then crossed over to wear Lens B for one week.	Lens B (Stenfilcon A), Then Lens A (Delefilcon A) Participants wore Lens B for one week, then crossed over to wear Lens A for one week.
Period 1 (One Week) STARTED	28	26
Period 1 (One Week) COMPLETED	28	26
Period 1 (One Week) NOT COMPLETED	0	0
Period 2 (One Week) STARTED	28	26
Period 2 (One Week) COMPLETED	28	26
Period 2 (One Week) 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

Baseline characteristics by cohort
Measure	Overall Study n=54 Participants All participants who were dispensed lenses and successfully completed the study.
Age, Continuous	34.6 years STANDARD_DEVIATION 13.5 • n=54 Participants
Sex: Female, Male Female	31 Participants n=54 Participants
Sex: Female, Male Male	23 Participants n=54 Participants

PRIMARY outcome

Timeframe: One week

Population: Lens A: all data for one participant was discounted, as the follow-up visit took place significantly outside the date range for this visit. Lens B: all data for a different participant was discounted, as the follow-up visit took place significantly outside the date range for this visit. Another participant's subjective scores and symptoms were not collected at the correct study visit in error, and their data was subsequently excluded from analysis.

Subjective handling rating on lens removal was measured on a scale of 0-100 where 0=Unmanageable and 100=Excellent removal.

Outcome measures

Outcome measures
Measure	Lens A n=53 Participants Participants that received Lens A during either the first or second period of the study.	Lens B n=52 Participants Participants that received Lens B during either the first or second period of the study.
Subjective Handling Rating on Lens Removal	85.5 units on a scale Standard Deviation 17.7	83.3 units on a scale Standard Deviation 20.1

SECONDARY outcome

Timeframe: One Week

Lens fit was reported as either optimum, acceptable, or unacceptable. To determine this, lens fit parameters (horizontal centration, vertical centration, corneal coverage, and lens movement) were measured on a 5-point scale (-2 to +2), where -2=Extremely nasal, 0=Optimum, and +2=Extremely temporal. Scores between -1 and +1 were considered "Acceptable". For overall lens fit to be 'acceptable', no parameters could be extreme. For a score to be 'optimum', all parameters needed to be optimum.

Outcome measures

Outcome measures
Measure	Lens A n=53 Participants Participants that received Lens A during either the first or second period of the study.	Lens B n=53 Participants Participants that received Lens B during either the first or second period of the study.
Overall Lens Fit at Follow-up Acceptable	53 Participants	53 Participants
Overall Lens Fit at Follow-up Unacceptable	0 Participants	0 Participants
Overall Lens Fit at Follow-up Optimum	23 Participants	20 Participants

SECONDARY outcome

Timeframe: One week

Population: Lens A: all data for one participant was discounted, as the follow-up visit took place significantly outside the date range for this visit. Lens B: all data for a different participant was discounted, as the follow-up visit took place significantly outside the date range for this visit. For parameter 'mucin balls', data from an additional participant was not collected in error.

Slit lamp biomicroscopy was used to assign grades to various biomicroscopic signs, as assessed by investigator, using Efron Grading Scales scored to the nearest 0.1 unit. Grading ranged from 0-4, where 0=None and 4=Severe.

Outcome measures

Outcome measures
Measure	Lens A n=53 Participants Participants that received Lens A during either the first or second period of the study.	Lens B n=53 Participants Participants that received Lens B during either the first or second period of the study.
Biomicroscopy Score at Follow-up Limbal hyperaemia	0.63 score on a scale Standard Deviation 0.41	0.64 score on a scale Standard Deviation 0.40
Biomicroscopy Score at Follow-up Conjunctival hyperaemia	0.82 score on a scale Standard Deviation 0.32	0.76 score on a scale Standard Deviation 0.31
Biomicroscopy Score at Follow-up Corneal vascularisation	0.05 score on a scale Standard Deviation 0.15	0.03 score on a scale Standard Deviation 0.09
Biomicroscopy Score at Follow-up Corneal oedema	0.00 score on a scale Standard Deviation 0.00	0.00 score on a scale Standard Deviation 0.00
Biomicroscopy Score at Follow-up Corneal staining	0.23 score on a scale Standard Deviation 0.37	0.20 score on a scale Standard Deviation 0.32
Biomicroscopy Score at Follow-up Conjunctival staining	0.41 score on a scale Standard Deviation 0.44	0.53 score on a scale Standard Deviation 0.49
Biomicroscopy Score at Follow-up Mucin balls	0.00 score on a scale Standard Deviation 0.00	0.10 score on a scale Standard Deviation 0.69
Biomicroscopy Score at Follow-up Papillary conjunctivitis	0.90 score on a scale Standard Deviation 0.40	0.90 score on a scale Standard Deviation 0.43
Biomicroscopy Score at Follow-up Blepharitis	0.06 score on a scale Standard Deviation 0.16	0.06 score on a scale Standard Deviation 0.15
Biomicroscopy Score at Follow-up Meibomian gland dysfunction	0.16 score on a scale Standard Deviation 0.32	0.09 score on a scale Standard Deviation 0.18

Adverse Events

Lens A

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Lens B

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lens A n=54 participants at risk Participants that received Lens A during either the first or second period of the study.	Lens B n=54 participants at risk Participants that received Lens B during either the first or second period of the study.
Eye disorders Swelling of Eyelid	0.00% 0/54 • The duration of the study, approximately 2 weeks per participant. There was 1 significant ocular adverse event and 1 non-significant ocular adverse event in 2 separate participants that occurred while wearing their habitual lens.	1.9% 1/54 • Number of events 1 • The duration of the study, approximately 2 weeks per participant. There was 1 significant ocular adverse event and 1 non-significant ocular adverse event in 2 separate participants that occurred while wearing their habitual lens.
Eye disorders Eye Redness	1.9% 1/54 • Number of events 1 • The duration of the study, approximately 2 weeks per participant. There was 1 significant ocular adverse event and 1 non-significant ocular adverse event in 2 separate participants that occurred while wearing their habitual lens.	0.00% 0/54 • The duration of the study, approximately 2 weeks per participant. There was 1 significant ocular adverse event and 1 non-significant ocular adverse event in 2 separate participants that occurred while wearing their habitual lens.
Eye disorders Corneal Scar	1.9% 1/54 • Number of events 1 • The duration of the study, approximately 2 weeks per participant. There was 1 significant ocular adverse event and 1 non-significant ocular adverse event in 2 separate participants that occurred while wearing their habitual lens.	0.00% 0/54 • The duration of the study, approximately 2 weeks per participant. There was 1 significant ocular adverse event and 1 non-significant ocular adverse event in 2 separate participants that occurred while wearing their habitual lens.
Eye disorders Corneal Abrasion	1.9% 1/54 • Number of events 1 • The duration of the study, approximately 2 weeks per participant. There was 1 significant ocular adverse event and 1 non-significant ocular adverse event in 2 separate participants that occurred while wearing their habitual lens.	0.00% 0/54 • The duration of the study, approximately 2 weeks per participant. There was 1 significant ocular adverse event and 1 non-significant ocular adverse event in 2 separate participants that occurred while wearing their habitual lens.
Eye disorders Conjunctival Redness	3.7% 2/54 • Number of events 2 • The duration of the study, approximately 2 weeks per participant. There was 1 significant ocular adverse event and 1 non-significant ocular adverse event in 2 separate participants that occurred while wearing their habitual lens.	0.00% 0/54 • The duration of the study, approximately 2 weeks per participant. There was 1 significant ocular adverse event and 1 non-significant ocular adverse event in 2 separate participants that occurred while wearing their habitual lens.

Additional Information

Director Global Clinical Affairs

CooperVision Inc.

Phone: +19256213761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place